Trial Outcomes & Findings for Time Restricted Eating (TRE) Among Native Hawaiian/Pacific Islander Women at Risk for Endometrial Cancer (NCT NCT04763902)
NCT ID: NCT04763902
Last Updated: 2026-07-29
Results Overview
Count of participants whose pre-made control diet meals were delivered on schedule. Participants were provided with pre-made, frozen lunch and dinner meals 7 days a week during both 4-week diet phases.
COMPLETED
NA
39 participants
From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
2026-07-29
Participant Flow
25 participants who participated in the focus groups did not continue to the randomized portion of the study.
Participant milestones
| Measure |
FOCUS Group Only
Native Hawaiian/Pacific Islander (NHPI) women at risk for endometrial cancer were recruited to conduct virtual focus groups. These focus groups will took place via private videoconference, and a language translator was provided as necessary. The focus groups were attended by a NHPI Community Expert.
The PI and a project assistant used a 9-question, semi-structured focus group guide for up to 90-minutes. Two additional study team members were present as note takers. Questions were designed to understand sociocultural influences on dietary behavior; questions on social eating, meal timing, and dietary preferences, soliciting feedback on study intervention delivery design, and perceptions of weight loss and body image.
Focus group participants were invited during the focus group to learn more about participation in the TRE intervention if they met eligibility criteria.
Participants in this arm did not continue to be randomized to one of the study arms ("TRE, Then Control" or "Control, Then TRE")
|
Time Restricted Eating (TRE) Schedule, Then Control
In this arm of the 14-week randomized dietary crossover study, participants will undergo a 2-week run-in period, followed by an 8-hour TRE protocol (comprising 8 hours of feeding and 16 hours of fasting periods), a 4-week washout period, and a 4-week control diet schedule.
Behavioral: Time Restricted Eating (TRE) Schedule Women will receive prepared frozen lunch and dinner meals as per the control schedule, but will be asked to consume daily meals, snacks, and calorie-containing beverages within an 8 to 10-hour period that fits their schedule. They will be asked to maintain their regular sleep and physical activity schedule. Fasting period will ramp up during the first week (e.g., Days 1-3, 12-14 h per day, Days 4-6, 14-16 h per day, Days 7+, 16 h per day). Women will be asked to schedule the feeding period at the same time each day. They will be allowed to consume water and 1-2 servings of very low-calorie drinks and foods (e.g., herbal tea, diet drinks, mints, gum containing \< 4 kcal/serving) to increase compliance. All meals (control and TRE) will be provided by the Metabolic Kitchen developed in collaboration with the department of Nutrition and Integrative Physiology.
Behavioral: Control Schedule Women will receive frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu will be designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
Control Schedule, Then TRE
In this arm of the 14-week randomized dietary crossover study, participants will undergo a 2-week run-in period, followed by 4-week control diet schedule, a 4-week washout period, and an 8-hour TRE protocol (comprising 8 hours of feeding and 16 hours of fasting periods)
Behavioral: Time Restricted Eating (TRE) Schedule Women will receive prepared frozen lunch and dinner meals as per the control schedule, but will be asked to consume daily meals, snacks, and calorie-containing beverages within an 8 to 10-hour period that fits their schedule. They will be asked to maintain their regular sleep and physical activity schedule. Fasting period will ramp up during the first week (e.g., Days 1-3, 12-14 h per day, Days 4-6, 14-16 h per day, Days 7+, 16 h per day). Women will be asked to schedule the feeding period at the same time each day. They will be allowed to consume water and 1-2 servings of very low-calorie drinks and foods (e.g., herbal tea, diet drinks, mints, gum containing \< 4 kcal/serving) to increase compliance. All meals (control and TRE) will be provided by the Metabolic Kitchen developed in collaboration with the department of Nutrition and Integrative Physiology.
Behavioral: Control Schedule Women will receive frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu will be designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|---|
|
Focus Groups
STARTED
|
25
|
6
|
8
|
|
Focus Groups
COMPLETED
|
25
|
6
|
8
|
|
Focus Groups
NOT COMPLETED
|
0
|
0
|
0
|
|
Run In (2 Weeks)
STARTED
|
0
|
6
|
8
|
|
Run In (2 Weeks)
COMPLETED
|
0
|
6
|
7
|
|
Run In (2 Weeks)
NOT COMPLETED
|
0
|
0
|
1
|
|
First Intervention (4 Weeks)
STARTED
|
0
|
6
|
7
|
|
First Intervention (4 Weeks)
COMPLETED
|
0
|
6
|
6
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
0
|
0
|
1
|
|
Washout (4 Weeks)
STARTED
|
0
|
6
|
6
|
|
Washout (4 Weeks)
COMPLETED
|
0
|
6
|
5
|
|
Washout (4 Weeks)
NOT COMPLETED
|
0
|
0
|
1
|
|
Second Intervention (4 Weeks)
STARTED
|
0
|
6
|
5
|
|
Second Intervention (4 Weeks)
COMPLETED
|
0
|
6
|
5
|
|
Second Intervention (4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
FOCUS Group Only
Native Hawaiian/Pacific Islander (NHPI) women at risk for endometrial cancer were recruited to conduct virtual focus groups. These focus groups will took place via private videoconference, and a language translator was provided as necessary. The focus groups were attended by a NHPI Community Expert.
The PI and a project assistant used a 9-question, semi-structured focus group guide for up to 90-minutes. Two additional study team members were present as note takers. Questions were designed to understand sociocultural influences on dietary behavior; questions on social eating, meal timing, and dietary preferences, soliciting feedback on study intervention delivery design, and perceptions of weight loss and body image.
Focus group participants were invited during the focus group to learn more about participation in the TRE intervention if they met eligibility criteria.
Participants in this arm did not continue to be randomized to one of the study arms ("TRE, Then Control" or "Control, Then TRE")
|
Time Restricted Eating (TRE) Schedule, Then Control
In this arm of the 14-week randomized dietary crossover study, participants will undergo a 2-week run-in period, followed by an 8-hour TRE protocol (comprising 8 hours of feeding and 16 hours of fasting periods), a 4-week washout period, and a 4-week control diet schedule.
Behavioral: Time Restricted Eating (TRE) Schedule Women will receive prepared frozen lunch and dinner meals as per the control schedule, but will be asked to consume daily meals, snacks, and calorie-containing beverages within an 8 to 10-hour period that fits their schedule. They will be asked to maintain their regular sleep and physical activity schedule. Fasting period will ramp up during the first week (e.g., Days 1-3, 12-14 h per day, Days 4-6, 14-16 h per day, Days 7+, 16 h per day). Women will be asked to schedule the feeding period at the same time each day. They will be allowed to consume water and 1-2 servings of very low-calorie drinks and foods (e.g., herbal tea, diet drinks, mints, gum containing \< 4 kcal/serving) to increase compliance. All meals (control and TRE) will be provided by the Metabolic Kitchen developed in collaboration with the department of Nutrition and Integrative Physiology.
Behavioral: Control Schedule Women will receive frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu will be designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
Control Schedule, Then TRE
In this arm of the 14-week randomized dietary crossover study, participants will undergo a 2-week run-in period, followed by 4-week control diet schedule, a 4-week washout period, and an 8-hour TRE protocol (comprising 8 hours of feeding and 16 hours of fasting periods)
Behavioral: Time Restricted Eating (TRE) Schedule Women will receive prepared frozen lunch and dinner meals as per the control schedule, but will be asked to consume daily meals, snacks, and calorie-containing beverages within an 8 to 10-hour period that fits their schedule. They will be asked to maintain their regular sleep and physical activity schedule. Fasting period will ramp up during the first week (e.g., Days 1-3, 12-14 h per day, Days 4-6, 14-16 h per day, Days 7+, 16 h per day). Women will be asked to schedule the feeding period at the same time each day. They will be allowed to consume water and 1-2 servings of very low-calorie drinks and foods (e.g., herbal tea, diet drinks, mints, gum containing \< 4 kcal/serving) to increase compliance. All meals (control and TRE) will be provided by the Metabolic Kitchen developed in collaboration with the department of Nutrition and Integrative Physiology.
Behavioral: Control Schedule Women will receive frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu will be designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|---|
|
Run In (2 Weeks)
Withdrawal by Subject
|
0
|
0
|
1
|
|
First Intervention (4 Weeks)
Withdrawal by Subject
|
0
|
0
|
1
|
|
Washout (4 Weeks)
Withdrawn by Study
|
0
|
0
|
1
|
Baseline Characteristics
Height and weight were missing for one participant.
Baseline characteristics by cohort
| Measure |
Focus Groups Only
n=25 Participants
Native Hawaiian/Pacific Islander (NHPI) women at risk for endometrial cancer were recruited to conduct virtual focus groups. These focus groups will took place via private videoconference, and a language translator was provided as necessary. The focus groups were attended by a NHPI Community Expert.
The PI and a project assistant used a 9-question, semi-structured focus group guide for up to 90-minutes. Two additional study team members were present as note takers. Questions were designed to understand sociocultural influences on dietary behavior; questions on social eating, meal timing, and dietary preferences, soliciting feedback on study intervention delivery design, and perceptions of weight loss and body image.
Focus group participants were invited during the focus group to learn more about participation in the TRE intervention if they met eligibility criteria. If a participant expresses interest in continuing with the TRE dietary intervention, the clinical coordinator conducted a remote informed consent and the participant was randomized to one of the study arms.
|
Control Schedule, Then TRE
n=8 Participants
In this arm of the 14-week randomized dietary crossover study, participants will undergo a 2-week run-in period, followed by 4-week control diet schedule, a 4-week washout period, and an 8-hour TRE protocol (comprising 8 hours of feeding and 16 hours of fasting periods) Behavioral: Time Restricted Eating (TRE) Schedule Women will receive prepared frozen lunch and dinner meals as per the control schedule, but will be asked to consume daily meals, snacks, and calorie-containing beverages within an 8 to 10-hour period that fits their schedule. They will be asked to maintain their regular sleep and physical activity schedule. Fasting period will ramp up during the first week (e.g., Days 1-3, 12-14 h per day, Days 4-6, 14-16 h per day, Days 7+, 16 h per day). Women will be asked to schedule the feeding period at the same time each day. They will be allowed to consume water and 1-2 servings of very low-calorie drinks and foods (e.g., herbal tea, diet drinks, mints, gum containing \< 4 kcal/serving) to increase compliance. All meals (control and TRE) will be provided by the Metabolic Kitchen developed in collaboration with the department of Nutrition and Integrative Physiology.
Behavioral: Control Schedule Women will receive frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu will be designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
Time Restricted Eating (TRE) Schedule, Then Control
n=6 Participants
In this arm of the 14-week randomized dietary crossover study, participants will undergo a 2-week run-in period, followed by an 8-hour TRE protocol (comprising 8 hours of feeding and 16 hours of fasting periods), a 4-week washout period, and a 4-week control diet schedule.
Behavioral: Time Restricted Eating (TRE) Schedule Women will receive prepared frozen lunch and dinner meals as per the control schedule, but will be asked to consume daily meals, snacks, and calorie-containing beverages within an 8 to 10-hour period that fits their schedule. They will be asked to maintain their regular sleep and physical activity schedule. Fasting period will ramp up during the first week (e.g., Days 1-3, 12-14 h per day, Days 4-6, 14-16 h per day, Days 7+, 16 h per day). Women will be asked to schedule the feeding period at the same time each day. They will be allowed to consume water and 1-2 servings of very low-calorie drinks and foods (e.g., herbal tea, diet drinks, mints, gum containing \< 4 kcal/serving) to increase compliance. All meals (control and TRE) will be provided by the Metabolic Kitchen developed in collaboration with the department of Nutrition and Integrative Physiology.
Behavioral: Control Schedule Women will receive frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu will be designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=39 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=25 Participants
|
8 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
39 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=39 Participants
|
|
Age, Continuous
|
33.56 years
STANDARD_DEVIATION 10.63 • n=25 Participants
|
60.91 years
STANDARD_DEVIATION 4.82 • n=8 Participants
|
31.04 years
STANDARD_DEVIATION 2.74 • n=6 Participants
|
32.63 years
STANDARD_DEVIATION 8.84 • n=39 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=25 Participants
|
8 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
39 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=25 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
23 Participants
n=25 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
36 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=25 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=25 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=25 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
8 participants
n=8 Participants
|
6 participants
n=6 Participants
|
39 participants
n=39 Participants
|
|
Body Mass Index
|
38.74 Kg/m^2
STANDARD_DEVIATION 10.04 • n=25 Participants • Height and weight were missing for one participant.
|
39.97 Kg/m^2
STANDARD_DEVIATION 8.53 • n=7 Participants • Height and weight were missing for one participant.
|
38.58 Kg/m^2
STANDARD_DEVIATION 7.16 • n=6 Participants • Height and weight were missing for one participant.
|
38.94 Kg/m^2
STANDARD_DEVIATION 9.18 • n=38 Participants • Height and weight were missing for one participant.
|
|
Waist (cm)
|
—
|
114.13 cm
STANDARD_DEVIATION 22.33 • n=8 Participants • This measure was not complete for participants who did not continue to the randomized period of the study (25 participants).
|
119.30 cm
STANDARD_DEVIATION 19.40 • n=6 Participants • This measure was not complete for participants who did not continue to the randomized period of the study (25 participants).
|
116.34 cm
STANDARD_DEVIATION 20.50 • n=14 Participants • This measure was not complete for participants who did not continue to the randomized period of the study (25 participants).
|
PRIMARY outcome
Timeframe: up to 1 day after screeningPopulation: All study participants screened
The feasibility of the Time-Restricted Eating (TRE) intervention will be measured by calculating the proportion (%) of women who were consented and enrolled in the study out of all the participants who screened for the trial.
Outcome measures
| Measure |
Screened and Consented
n=27 Participants
Participants screened and consented
|
Control Schedule
Participants received a 4-week control diet schedule.
Women received frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu were designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|
|
Proportion of Participants Referred That Were Consented and Enrolled
|
17 Participants
|
—
|
PRIMARY outcome
Timeframe: From the baseline of the randomized portion of the study to Visit 5, up to 19 weeksPopulation: One participant withdrew from the study prior to starting either intervention and is not included in this outcome measure (TRE and Control Schedule). One participant in the "Control Schedule, Then TRE" arm withdrew during the washout period and is not included in the TRE Schedule. One participant in the "Control Schedule, Then TRE" arm withdrew during the Control period and is not included in the TRE Schedule.
To assess the feasibility of the TRE intervention. This outcome measure will report the number of participants who withdrew throughout the course of the interventional component of the study.
Outcome measures
| Measure |
Screened and Consented
n=11 Participants
Participants screened and consented
|
Control Schedule
n=13 Participants
Participants received a 4-week control diet schedule.
Women received frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu were designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|
|
Attrition
Did Not Complete the Intervention
|
0 Participants
|
1 Participants
|
|
Attrition
Completed the Intervention
|
11 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: From the baseline of the randomized portion of the study to Visit 5, up to 19 weeksThis outcome measure will report the count of participants who completed each study assessment per protocol. Participants who were randomized and withdrew from the study are included as missed assessments. After the TRE Schedule (Visit 3 or 5), waist circumference, weight, blood pressure, blood, and stool were collected. After the Control Schedule (Visit 3 or 5), waist circumference, weight, blood pressure, blood, and stool were collected. This outcome measure will report the count of participants who completed each assessment
Outcome measures
| Measure |
Screened and Consented
n=14 Participants
Participants screened and consented
|
Control Schedule
n=14 Participants
Participants received a 4-week control diet schedule.
Women received frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu were designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|
|
Protocol Items Completed
Waist Circumference · Assessment Not Complete
|
3 Participants
|
4 Participants
|
|
Protocol Items Completed
Waist Circumference · Assessment Complete
|
11 Participants
|
10 Participants
|
|
Protocol Items Completed
Weight · Assessment Complete
|
11 Participants
|
10 Participants
|
|
Protocol Items Completed
Blood Pressure · Assessment Complete
|
10 Participants
|
12 Participants
|
|
Protocol Items Completed
Blood Pressure · Assessment Not Complete
|
4 Participants
|
2 Participants
|
|
Protocol Items Completed
Stool Collection · Assessment Complete
|
7 Participants
|
7 Participants
|
|
Protocol Items Completed
Stool Collection · Assessment Not Complete
|
7 Participants
|
7 Participants
|
|
Protocol Items Completed
Weight · Assessment Not Complete
|
3 Participants
|
4 Participants
|
|
Protocol Items Completed
Blood Collection · Assessment Complete
|
8 Participants
|
6 Participants
|
|
Protocol Items Completed
Blood Collection · Assessment Not Complete
|
6 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeksPopulation: One participant withdrew from the study prior to starting either intervention and is not included in the TRE Schedule. One participant in the "Control Schedule, Then TRE" arm withdrew during the washout period and is not included in the TRE Schedule. One participant in the "Control Schedule, Then TRE" arm withdrew during the Control period and is not included in the TRE Schedule.
This outcome measure will report the mean percentage of TRE-adherent days. TRE adherence is achieved when participants fast for 14-18 hours per day during the TRE phase, as measured by a mealtime log using the MyCircadianClock phone app.
Outcome measures
| Measure |
Screened and Consented
n=11 Participants
Participants screened and consented
|
Control Schedule
Participants received a 4-week control diet schedule.
Women received frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu were designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|
|
Percentage of TRE-Adherent Days
|
11.23 percentage of TRE-adherent days
Standard Deviation 21
|
—
|
PRIMARY outcome
Timeframe: From the baseline of the randomized portion of the study to Visit 5, up to 19 weeksPopulation: Three participants did not start or complete the TRE schedule and were not included in this outcome measure.
Count of participants whose pre-made control diet meals were delivered on schedule. Participants were provided with pre-made, frozen lunch and dinner meals 7 days a week during both 4-week diet phases.
Outcome measures
| Measure |
Screened and Consented
n=11 Participants
Participants screened and consented
|
Control Schedule
n=11 Participants
Participants received a 4-week control diet schedule.
Women received frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu were designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|
|
Meals Delivered On Schedule
|
10 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: From the baseline of the randomized portion of the study to Visit 5, up to 19 weeksPopulation: Three participants did not start or complete the TRE schedule and were not included in the analysis of this outcome measure.
To assess feasibility of the study, the percentage of in-person study visits completed out of 5 study visits for each participant was calculated. This outcome measure will report the mean percentage of completed study visits. This outcome measure was assessed throughout the course of the study during both the TRE and Control Schedules; it is not possible to regroup participants to report Arms/Groups "per intervention".
Outcome measures
| Measure |
Screened and Consented
n=6 Participants
Participants screened and consented
|
Control Schedule
n=5 Participants
Participants received a 4-week control diet schedule.
Women received frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu were designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|
|
Study Visit Completion
|
97 percentage of study visit completed
Standard Deviation 8
|
100 percentage of study visit completed
Standard Deviation 0
|
SECONDARY outcome
Timeframe: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeksPopulation: Three participants did not start or complete the TRE schedule and were not included in this outcome measure. One participant missed the post-TRE visit. Two participants had missing Blood Pressure data at the post-control visit.
Blood pressure was measured using an electronic blood pressure monitor after the TRE phase and after the control diet phase.
Outcome measures
| Measure |
Screened and Consented
n=10 Participants
Participants screened and consented
|
Control Schedule
n=12 Participants
Participants received a 4-week control diet schedule.
Women received frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu were designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|
|
Blood Pressure Measured With Electronic Blood Pressure Monitor
Diastolic Blood Pressure
|
77.7 mmHg (millimeters of mercury)
Standard Deviation 12.94
|
78.52 mmHg (millimeters of mercury)
Standard Deviation 13.55
|
|
Blood Pressure Measured With Electronic Blood Pressure Monitor
Systolic Blood Pressure
|
127.2 mmHg (millimeters of mercury)
Standard Deviation 19.01
|
124.33 mmHg (millimeters of mercury)
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeksPopulation: Three participants did not start or complete the TRE schedule and were not included in this outcome measure. One participant missed the post-TRE visit. Three participants had missing waist circumference data at the post-control visit.
Waist circumference was measured by trained study staff using a tape measure and standardized protocols. Waist circumference was measured after the TRE Schedule and after the Control Schedule.
Outcome measures
| Measure |
Screened and Consented
n=10 Participants
Participants screened and consented
|
Control Schedule
n=11 Participants
Participants received a 4-week control diet schedule.
Women received frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu were designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|
|
Waist Circumference
|
114.5 cm
Standard Deviation 14.87
|
122.2 cm
Standard Deviation 28.98
|
SECONDARY outcome
Timeframe: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeksPopulation: Three participants did not start or complete the TRE schedule and were not included in this outcome measure. One participant missed the post-TRE visit. Four participants had missing weight data at the post-control visit.
Participants' height and weight was measured by trained study staff using a stadiometer and calibrated weighing scales. Measures were done in triplicate (duplicate if measures did not agree). Height and weight were used to calculate body mass index in kilograms divided by height in meters-squared. BMI was measured after the TRE Schedule and after the Control Schedule.
Outcome measures
| Measure |
Screened and Consented
n=11 Participants
Participants screened and consented
|
Control Schedule
n=10 Participants
Participants received a 4-week control diet schedule.
Women received frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu were designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|
|
Body Mass Index (BMI) Assessed Via Stadiometer and Calibrated Scales
|
41.05 kg/m^2
Standard Deviation 6.57
|
41.84 kg/m^2
Standard Deviation 7.44
|
SECONDARY outcome
Timeframe: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeksPopulation: Three participants did not start or complete the TRE schedule and were not included in this outcome measure. One participant missed the post-TRE visit. Two participants had missing data at the post-TRE visit. Seven participants had missing data at the post-Control visit.
Fasting glucose was measured at Associated Regional and University Pathologists (ARUP) Laboratories. Fasting blood samples were taken from participants by a trained phlebotomist using standard protocols after the TRE Schedule and after the Control Schedule.
Outcome measures
| Measure |
Screened and Consented
n=8 Participants
Participants screened and consented
|
Control Schedule
n=7 Participants
Participants received a 4-week control diet schedule.
Women received frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu were designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|
|
Fasting Blood Glucose Level
|
96.13 mg/dL
Standard Deviation 7.83
|
97.86 mg/dL
Standard Deviation 7.95
|
SECONDARY outcome
Timeframe: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeksPopulation: Three participants did not start or complete the TRE schedule and were not included in this outcome measure. One participant missed the post-TRE visit. Three participants had missing data at the post-TRE visit. Seven participants had missing data at the post-Control visit.
C-peptide was measured at ARUP Laboratories. Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.
Outcome measures
| Measure |
Screened and Consented
n=7 Participants
Participants screened and consented
|
Control Schedule
n=7 Participants
Participants received a 4-week control diet schedule.
Women received frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu were designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|
|
Fasting Blood C-peptide Level
|
2.23 ng/mL
Standard Deviation 0.57
|
2.43 ng/mL
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeksPopulation: Three participants did not start or complete the TRE schedule and were not included in this outcome measure. One participant missed the post-TRE visit. Two participants had missing data at the post-TRE visit. Seven participants had missing data at the post-Control visit.
Blood triglyceride level was measured at ARUP Laboratories. Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.
Outcome measures
| Measure |
Screened and Consented
n=8 Participants
Participants screened and consented
|
Control Schedule
n=7 Participants
Participants received a 4-week control diet schedule.
Women received frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu were designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|
|
Fasting Blood Triglyceride Level
|
139.75 mg/dL
Standard Deviation 96.70
|
129.57 mg/dL
Standard Deviation 122.25
|
SECONDARY outcome
Timeframe: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeksPopulation: Three participants did not start or complete the TRE schedule and were not included in this outcome measure. One participant missed the post-TRE visit. Two participants had missing data at the post-TRE visit. Seven participants had missing data at the post-Control visit.
Blood HDL-cholesterol level was measured at ARUP Laboratories. Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.
Outcome measures
| Measure |
Screened and Consented
n=8 Participants
Participants screened and consented
|
Control Schedule
n=7 Participants
Participants received a 4-week control diet schedule.
Women received frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu were designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|
|
Fasting Blood High-density Lipoprotein(HDL)-Cholesterol Level
|
45 mg/dL
Standard Deviation 6.89
|
44 mg/dL
Standard Deviation 8.04
|
SECONDARY outcome
Timeframe: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeksPopulation: Three participants did not start or complete the TRE schedule and were not included in this outcome measure. One participant missed the post-TRE visit. Two participants had missing data at the post-TRE visit. Seven participants had missing data at the post-Control visit.
Blood C-peptide level was measured at ARUP Laboratories. Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.
Outcome measures
| Measure |
Screened and Consented
n=8 Participants
Participants screened and consented
|
Control Schedule
n=7 Participants
Participants received a 4-week control diet schedule.
Women received frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu were designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.
|
|---|---|---|
|
Fasting Blood High Sensitivity C-reactive Protein
|
3.74 mg/L
Standard Deviation 3.42
|
4.77 mg/L
Standard Deviation 5.78
|
Adverse Events
Time Restricted Eating (TRE) Schedule
Control Schedule
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place