Trial Outcomes & Findings for (R33 Phase) DELISH Study: Diabetes Education to Lower Insulin, Sugars, and Hunger (NCT NCT03837405)
NCT ID: NCT03837405
Last Updated: 2026-06-17
Results Overview
Percent of participant ketone measures \> or = 0.5 mmol/L during trial, by study arm
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
125 participants
Primary outcome timeframe
Measures from ketone measure initiation (week 5) to 12 months. Ketones were measured daily over 7 days at 5 study timepoints: 5 weeks, 3, 6, 9, and 12 months.
Results posted on
2026-06-17
Participant Flow
Participant milestones
| Measure |
Diet Education Initial Randomization
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness Initial Randomization
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfuless: Mindful eating app use plus group sessions to learn mindfulness
|
Ed+MBI High Adherence/Low Intensity Maintenance
Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Ed+MBI arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed+MBI participants with high adherence randomized to low intensity maintenance.
|
Ed+MBI High Adherence/Medium Intensity Maintenance
Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Ed+MBI arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed+MBI participants with high adherence randomized to medium intensity maintenance.
|
Ed+MBI Low Adherence/Medium Intensity Maintenance
Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Ed+MBI arm participants with low adherence during 3 month main intervention period were randomized to either medium or high intensity maintenance. This arm consists of Ed+MBI participants with high adherence randomized to medium intensity maintenance.
|
Ed+MBI Low Adherence/High Intensity Maintenance
Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Ed+MBI arm participants with low adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed+MBI participants with low adherence randomized to high intensity maintenance.
Ed+MBI arm participants with low adherence during main intervention period randomized to high intensity maintenance.
|
Ed Arm High Adherence/Low Intensity Maintenance
Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Ed arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed participants with high adherence randomized to low intensity maintenance.
|
Ed High Adherence/Medium Intensity Maintenance
Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Ed arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed participants with high adherence randomized to medium intensity maintenance.
|
Ed Low Adherence/Medium Intensity Maintenance
Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Ed arm participants with low adherence during 3 month main intervention period were randomized to either medium or high intensity maintenance. This arm consists of Ed participants with low adherence randomized to medium intensity maintenance.
|
Ed Low Adherence/High Intensity Maintenance
Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Ed arm participants with low adherence during 3 month main intervention period were randomized to either medium or high intensity maintenance. This arm consists of Ed participants with low adherence randomized to high intensity maintenance.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1: 3-month Main Intervention
STARTED
|
63
|
62
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1: 3-month Main Intervention
COMPLETED
|
59
|
60
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1: 3-month Main Intervention
NOT COMPLETED
|
4
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2: 9-month Maintenance
STARTED
|
0
|
0
|
15
|
15
|
15
|
15
|
15
|
14
|
14
|
16
|
|
Period 2: 9-month Maintenance
COMPLETED
|
0
|
0
|
15
|
14
|
15
|
13
|
14
|
14
|
12
|
15
|
|
Period 2: 9-month Maintenance
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
2
|
1
|
0
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
(R33 Phase) DELISH Study: Diabetes Education to Lower Insulin, Sugars, and Hunger
Baseline characteristics by cohort
| Measure |
Diet Education
n=63 Participants
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=62 Participants
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfuless: Mindful eating app use plus group sessions to learn mindfulness
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 10.0 • n=9 Participants
|
59.0 years
STANDARD_DEVIATION 10.3 • n=27 Participants
|
58.4 years
STANDARD_DEVIATION 10.1 • n=267 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=9 Participants
|
40 Participants
n=27 Participants
|
83 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
42 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
White
|
29 Participants
n=9 Participants
|
27 Participants
n=27 Participants
|
56 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Latino/a
|
10 Participants
n=9 Participants
|
13 Participants
n=27 Participants
|
23 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
14 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
25 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Other or more than one
|
3 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=9 Participants
|
62 participants
n=27 Participants
|
125 participants
n=267 Participants
|
|
Hemoglobin A1c
|
8.03 % of hemaglobin with glycosolation
STANDARD_DEVIATION 1.34 • n=9 Participants
|
8.54 % of hemaglobin with glycosolation
STANDARD_DEVIATION 1.50 • n=27 Participants
|
8.28 % of hemaglobin with glycosolation
STANDARD_DEVIATION 1.43 • n=267 Participants
|
PRIMARY outcome
Timeframe: Measures from ketone measure initiation (week 5) to 12 months. Ketones were measured daily over 7 days at 5 study timepoints: 5 weeks, 3, 6, 9, and 12 months.Population: All trial participants with ketone measures. Ketone measures started at week 5 of the trial and ended at month 12.
Percent of participant ketone measures \> or = 0.5 mmol/L during trial, by study arm
Outcome measures
| Measure |
Diet Education
n=62 Participants
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=60 Participants
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfuless: Mindful eating app use plus group sessions to learn mindfulness
|
|---|---|---|
|
Diet Adherence Between Intervention Arms as Measured by % of Ketones >= 0.5 mmol/L
|
72.2 % of ketone measures >= 0.5 mmol/L
Standard Deviation 23.5
|
70.4 % of ketone measures >= 0.5 mmol/L
Standard Deviation 21.1
|
PRIMARY outcome
Timeframe: Average of three measures, done at 3, 6 and 12 monthsPopulation: All study participants with 24-hour dietary recall data.
Average percent of participant measures with consumption of \< 50 grams/day of non-fiber carbohydrate (from 24-hour diet recall) by arm. Each participant was assigned a % of up to three measures reporting \< 50 grams/day of non-fiber carbohydrate consumption, and this percent was averaged across each arm.
Outcome measures
| Measure |
Diet Education
n=61 Participants
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=60 Participants
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfuless: Mindful eating app use plus group sessions to learn mindfulness
|
|---|---|---|
|
Diet Adherence Between Intervention Arms as Measured by % of Participants in Each Arm With < 50 Grams/Day of Non-fiber Carbohydrate on 24- Hour Diet Recall
|
50.2 percentage of participants
Interval 40.6 to 59.8
|
52.3 percentage of participants
Interval 42.5 to 62.1
|
SECONDARY outcome
Timeframe: change from baseline to 12 monthsPopulation: Participants with PEMS coping measured at 12 months
change in emotion-related eating as measured by the Coping subscale of the Palatable Eating Motives Scale (PEMS). The coping subscale ranges from 1 to 5 (based on a mean of 4 items), with higher values indicating more emotion-related eating (the intervention aimed to lower this score--lower scores represent improvement).
Outcome measures
| Measure |
Diet Education
n=56 Participants
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=57 Participants
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfuless: Mindful eating app use plus group sessions to learn mindfulness
|
|---|---|---|
|
Emotion-related Eating
|
-0.74 points on a scale
Interval -0.86 to -0.63
|
-0.76 points on a scale
Interval -0.92 to -0.6
|
SECONDARY outcome
Timeframe: change from baseline to 12 monthsPopulation: All study participants with 12 month data
Change in Hemoglobin A1c from baseline to 12 months with study arm
Outcome measures
| Measure |
Diet Education
n=49 Participants
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=53 Participants
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfuless: Mindful eating app use plus group sessions to learn mindfulness
|
|---|---|---|
|
Glycemic Control--HbA1c
|
-1.35 % of hemaglobin with glucose
Interval -1.57 to -1.14
|
-1.07 % of hemaglobin with glucose
Interval -1.39 to -0.75
|
SECONDARY outcome
Timeframe: Change from baseline to 12 monthsPopulation: Participants who completed the required number of EMA assessments at baseline and 12 months
Frequency of eating in response to cravings (indulgence) using ecological momentary assessment (EMA), operationalized as the percent of solicited occasions when a participant reported eating in response to cravings (rather than in response merely to hunger). Participants received 18 queries about eating in response to cravings over 3 days. Participants had to respond to at least 9 queries to have adequate data completeness for analysis. Frequency of eating in response to cravings is the proportion (scaled as a percent) of queries that participants responded to with responses that reported eating in response to cravings.
Outcome measures
| Measure |
Diet Education
n=57 Participants
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=56 Participants
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfuless: Mindful eating app use plus group sessions to learn mindfulness
|
|---|---|---|
|
Frequency of Eating in Response to Cravings
|
-17.3 Mean % EMA responses w/craving eating
Interval -21.1 to -13.5
|
-20.0 Mean % EMA responses w/craving eating
Interval -23.8 to -16.2
|
SECONDARY outcome
Timeframe: From 3 to 12 months, using measures done at 3, 6, and 12 monthsPopulation: All study participants with 24-hour dietary recall data.
Mean grams of non-fiber carbohydrate consumed per day (from 24-hour diet recall) during trial. We calculated average grams of non-fiber consumed per day across up to three measures during the trial for each participant, and this was averaged across arms.
Outcome measures
| Measure |
Diet Education
n=61 Participants
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=60 Participants
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfuless: Mindful eating app use plus group sessions to learn mindfulness
|
|---|---|---|
|
Diet Adherence Between Intervention Arms as Measured by Mean Grams of Non-fiber Carbohydrate Consumed Per Day From 24- Hour Diet Recall
|
61.4 grams non-fiber carbohydrate per day
Standard Deviation 36.1
|
55.2 grams non-fiber carbohydrate per day
Standard Deviation 32.3
|
SECONDARY outcome
Timeframe: change from baseline to 12 monthsPopulation: All trial participants with 12 month data
Change in stress-related eating as measured by Salzburg Stress Eating Scale. Range is from 1 to 5. Higher scores indicate greater stress-related eating.
Outcome measures
| Measure |
Diet Education
n=56 Participants
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=57 Participants
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfuless: Mindful eating app use plus group sessions to learn mindfulness
|
|---|---|---|
|
Salzburg Stress Eating Scale
|
-0.39 units on a scale
Interval -0.54 to -0.24
|
-0.41 units on a scale
Interval -0.6 to -0.21
|
SECONDARY outcome
Timeframe: change from baseline to 12 month weight dataPopulation: All trial participants with 12 month data
Body mass in kilograms (kg) from baseline to 12 months
Outcome measures
| Measure |
Diet Education
n=55 Participants
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=56 Participants
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfuless: Mindful eating app use plus group sessions to learn mindfulness
|
|---|---|---|
|
Weight Change
|
-9.12 kg
Interval -11.59 to -6.65
|
-6.53 kg
Interval -8.29 to -4.77
|
OTHER_PRE_SPECIFIED outcome
Timeframe: change from baseline to 12 monthsPopulation: All participants with 12 month data
Change in stress-related eating as measured by two questions about stress-related eating from the MIDUS study and one additional stress-related eating question. Range is 2 to 8. Higher scores indicate more stress-related eating.
Outcome measures
| Measure |
Diet Education
n=56 Participants
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=57 Participants
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfuless: Mindful eating app use plus group sessions to learn mindfulness
|
|---|---|---|
|
Stress-related Eating
|
-1.54 score on a scale
Interval -2.01 to -1.07
|
-1.34 score on a scale
Interval -1.71 to -0.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: change from baseline to 12 monthsPopulation: All participants with 12 month data
Change in Perceived Stress Scale total score. Range is 0 to 40. Higher scores indicate more perceived stress.
Outcome measures
| Measure |
Diet Education
n=56 Participants
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=57 Participants
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfuless: Mindful eating app use plus group sessions to learn mindfulness
|
|---|---|---|
|
Perceived Stress Scale
|
-2.47 score on a scale
Interval -4.23 to -0.71
|
-1.50 score on a scale
Interval -2.35 to -0.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: change from baseline to 12 monthsPopulation: All participants with 12 month lab data except n=6 with baseline insulin values out of recommended range for HOMA-2IR calculation (insulin should be 20 to 400 picamoles/L).
Insulin resistance estimated from the Homeostatic model assessment (HOMA) model 2 index of insulin resistance. The basic formula is: (glucose × insulin) / 22.5, where glucose is measured in mmol/L and insulin in mU/L. The computer assisted re-calibration in model 2 addresses variations in the glucose resistance of the peripheral tissue and liver, increases in the insulin secretion curve for glucose \> 180 mg/dL, and contribution of circulating pro-insulin. Higher values indicate more insulin resistance (worse outcome). The Oxford University HOMA-2IR calculator was used (https://process.innovation.ox.ac.uk/software/p/2112/homa2-calculator/1). HOMA index values \< 2.0 are generally considered normal and indicate adequate sensitivity of cells to insulin. HOMA index values between 2.0 and 2.5 may indicate borderline changes in insulin sensitivity. HOMA index values \> 2.5 clearly indicate insulin resistance.
Outcome measures
| Measure |
Diet Education
n=49 Participants
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=52 Participants
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfuless: Mindful eating app use plus group sessions to learn mindfulness
|
|---|---|---|
|
HOMA-2IR Index of Insulin Resistance
|
-0.94 index
Interval -1.25 to -0.62
|
-0.66 index
Interval -1.03 to -0.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: change from baseline to 12 monthsPopulation: All participants with fasting glucose levels at baseline and 12 months. There n=6 participants included without a confirmed report of fasting from the lab.
Glycemic control as measured by fasting blood glucose
Outcome measures
| Measure |
Diet Education
n=49 Participants
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=53 Participants
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfuless: Mindful eating app use plus group sessions to learn mindfulness
|
|---|---|---|
|
Fasting Glucose
|
-31.28 mg/dL
Interval -37.36 to -25.21
|
-22.48 mg/dL
Interval -30.11 to -14.85
|
OTHER_PRE_SPECIFIED outcome
Timeframe: change from baseline to 12 monthsPopulation: All participants with 12-month data.
Five-factor mindfulness questionnaire scale (FFMQ). Values represent an overall score summing five sub-scales. Range is 24 to 120. Higher scores indicate greater mindfulness.
Outcome measures
| Measure |
Diet Education
n=56 Participants
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=57 Participants
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfuless: Mindful eating app use plus group sessions to learn mindfulness
|
|---|---|---|
|
Mindfulness: FFMQ
|
4.59 score on a scale
Interval 2.11 to 7.07
|
5.46 score on a scale
Interval 1.75 to 9.17
|
Adverse Events
Period 1: Diet Education
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Period 1: Diet Education + Mindfulness
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Period 2: Ed+MBI High Adherence/Low Intensity Maintenance
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Period 2: Ed+MBI High Adherence/Medium Intensity Maintenance
Serious events: 0 serious events
Other events: 8 other events
Deaths: 1 deaths
Period 2: Ed+MBI Low Adherence/Medium Intensity Maintenance
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Period 2: Ed+MBI Low Adherence/High Intensity Maintenance
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Period 2: Ed High Adherence: Low Intensity
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Period 2: Ed High Adherence: Medium Intensity
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Period 2: Ed Low Adherence: Medium Intensity
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Period 2: Ed Low Adherence: High Intensity
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Period 2: Ed+MBI n/a (Assessment Only)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Period 2: Ed n/a (Assessment Only)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Period 1: Diet Education
n=63 participants at risk
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
|
Period 1: Diet Education + Mindfulness
n=62 participants at risk
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
|
Period 2: Ed+MBI High Adherence/Low Intensity Maintenance
n=15 participants at risk
Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. Ed+MBI arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed+MBI participants with high adherence randomized to low intensity maintenance.
|
Period 2: Ed+MBI High Adherence/Medium Intensity Maintenance
n=15 participants at risk
Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Ed+MBI arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed+MBI participants with high adherence randomized to medium intensity maintenance.
|
Period 2: Ed+MBI Low Adherence/Medium Intensity Maintenance
n=15 participants at risk
Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Ed+MBI arm participants with low adherence during 3 month main intervention period were randomized to either medium or high intensity maintenance. This arm consists of Ed+MBI participants with high adherence randomized to medium intensity maintenance.
|
Period 2: Ed+MBI Low Adherence/High Intensity Maintenance
n=15 participants at risk
Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Ed+MBI arm participants with low adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed+MBI participants with low adherence randomized to high intensity maintenance.
|
Period 2: Ed High Adherence: Low Intensity
n=15 participants at risk
Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Ed arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed participants with high adherence randomized to low intensity maintenance.
|
Period 2: Ed High Adherence: Medium Intensity
n=14 participants at risk
Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Ed arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed participants with high adherence randomized to medium intensity maintenance.
|
Period 2: Ed Low Adherence: Medium Intensity
n=14 participants at risk
Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Ed arm participants with low adherence during 3 month main intervention period were randomized to either medium or high intensity maintenance. This arm consists of Ed participants with low adherence randomized to medium intensity maintenance.
|
Period 2: Ed Low Adherence: High Intensity
n=16 participants at risk
Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
Ed arm participants with low adherence during 3 month main intervention period were randomized to either medium or high intensity maintenance. This arm consists of Ed participants with low adherence randomized to high intensity maintenance.
|
Period 2: Ed+MBI n/a (Assessment Only)
n=2 participants at risk
This group consists of Ed+MBI participants who were not re-randomized for maintenance phase because they dropped out of the intervention, but may have continued to complete assessments including adverse event reporting.
|
Period 2: Ed n/a (Assessment Only)
n=4 participants at risk
This group consists of Ed participants who were not re-randomized for maintenance phase because they dropped out of the intervention, but may have continued to complete assessments including adverse event reporting.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
15.9%
10/63 • Number of events 13 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
21.0%
13/62 • Number of events 18 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
0.00%
0/15 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
6.7%
1/15 • Number of events 5 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
13.3%
2/15 • Number of events 3 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
6.7%
1/15 • Number of events 1 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
6.7%
1/15 • Number of events 1 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
0.00%
0/14 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
7.1%
1/14 • Number of events 1 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
6.2%
1/16 • Number of events 1 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
0.00%
0/2 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
0.00%
0/4 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
|
Cardiac disorders
Hypercholesterolemia
|
4.8%
3/63 • Number of events 3 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
1.6%
1/62 • Number of events 1 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
13.3%
2/15 • Number of events 2 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
13.3%
2/15 • Number of events 2 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
20.0%
3/15 • Number of events 3 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
6.7%
1/15 • Number of events 1 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
13.3%
2/15 • Number of events 2 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
21.4%
3/14 • Number of events 3 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
0.00%
0/14 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
12.5%
2/16 • Number of events 2 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
0.00%
0/2 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
0.00%
0/4 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
|
Cardiac disorders
Hypertriglyceridemia
|
1.6%
1/63 • Number of events 1 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
3.2%
2/62 • Number of events 2 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
13.3%
2/15 • Number of events 2 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
0.00%
0/15 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
13.3%
2/15 • Number of events 2 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
13.3%
2/15 • Number of events 2 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
0.00%
0/15 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
7.1%
1/14 • Number of events 1 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
7.1%
1/14 • Number of events 1 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
6.2%
1/16 • Number of events 1 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
0.00%
0/2 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
0.00%
0/4 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
|
General disorders
Other
|
23.8%
15/63 • Number of events 22 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
16.1%
10/62 • Number of events 19 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
40.0%
6/15 • Number of events 9 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
40.0%
6/15 • Number of events 12 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
73.3%
11/15 • Number of events 13 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
20.0%
3/15 • Number of events 3 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
46.7%
7/15 • Number of events 9 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
28.6%
4/14 • Number of events 8 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
42.9%
6/14 • Number of events 9 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
31.2%
5/16 • Number of events 6 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
0.00%
0/2 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
0.00%
0/4 • 1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
|
Additional Information
Frederick Hecht, MD
University of California, San Francisco
Phone: (415) 353-9743
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place