Trial Outcomes & Findings for Predicting Adherence to a Heart-Healthy Diet in Lean and Obese Individuals (NCT NCT01862796)
NCT ID: NCT01862796
Last Updated: 2019-08-15
Results Overview
An adherence score is calculated each week by summing 7 measurements of adherence and dividing by 21, the maximum score, with range from 0 (no adherence) to 1 (perfectly adherent). For each of the 7 measures a higher score means better adherence: \[1\] Attendance (0-2), \[2\] Food diaries (0-3), \[3\] 24-hour food recall via interview (0-3), \[4\] computer survey (0-3), \[5\] 24-hour food recall via interview (0-3), \[6\] Ecological momentary assessment (0-6), and \[7\] On time arrival for session (0-1). The final score is calculated as the average of the six weekly scores.
COMPLETED
NA
100 participants
Average over 6 weeks
2019-08-15
Participant Flow
100 participants were assessed for eligibility, 30 were ineligible and 9 did not complete the run-in phase. Sixty-one were assigned to groups.
Participant milestones
| Measure |
Obese Underfeeding (UF)
Obese randomized to received a 35% calorie reduced diet
Underfeeding diet: Heart healthy diet with 35% reduced calories
|
Obese Weight Maintaining (WMEN)
Randomized to receive a weight-maintaining diet
Weight maintaining diet: Heart healthy weight-maintaining diet
|
Lean Weight Maintaining (WMEN)
Normal weight individuals receiving a weight-maintaining energy needs diet
Weight maintaining diet: Heart healthy weight-maintaining diet
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
24
|
|
Overall Study
COMPLETED
|
19
|
18
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Obese Underfeeding (UF)
Obese randomized to received a 35% calorie reduced diet
Underfeeding diet: Heart healthy diet with 35% reduced calories
|
Obese Weight Maintaining (WMEN)
Randomized to receive a weight-maintaining diet
Weight maintaining diet: Heart healthy weight-maintaining diet
|
Lean Weight Maintaining (WMEN)
Normal weight individuals receiving a weight-maintaining energy needs diet
Weight maintaining diet: Heart healthy weight-maintaining diet
|
|---|---|---|---|
|
Overall Study
Prohibited medications
|
0
|
0
|
1
|
Baseline Characteristics
Predicting Adherence to a Heart-Healthy Diet in Lean and Obese Individuals
Baseline characteristics by cohort
| Measure |
Obese Underfeeding (UF)
n=19 Participants
Obese randomized to received a 35% calorie reduced diet
Underfeeding diet: Heart healthy diet with 35% reduced calories
|
Obese Weight Maintaining (WMEN)
n=18 Participants
Randomized to receive a weight-maintaining diet
Weight maintaining diet: Heart healthy weight-maintaining diet
|
Lean Weight Maintaining (WMEN)
n=23 Participants
Normal weight individuals receiving a weight-maintaining energy needs diet
Weight maintaining diet: Heart healthy weight-maintaining diet
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 16.8 • n=99 Participants
|
49.8 years
STANDARD_DEVIATION 13.1 • n=107 Participants
|
49.7 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
48.3 years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race/Ethniticy · American Indian or Alaskan Native
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race/Ethniticy · Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race/Ethniticy · Native Hawaiian of Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race/Ethniticy · Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race/Ethniticy · Hispanic/Latino
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race/Ethniticy · Caucasian
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
18 participants
n=107 Participants
|
23 participants
n=206 Participants
|
60 participants
n=7 Participants
|
|
Weight, kg
|
111.0 kg
STANDARD_DEVIATION 29.1 • n=99 Participants
|
88.1 kg
STANDARD_DEVIATION 15.3 • n=107 Participants
|
63.9 kg
STANDARD_DEVIATION 8.0 • n=206 Participants
|
86.1 kg
STANDARD_DEVIATION 27.3 • n=7 Participants
|
|
Height, cm
|
170.5 cm
STANDARD_DEVIATION 10.4 • n=99 Participants
|
161.7 cm
STANDARD_DEVIATION 9.4 • n=107 Participants
|
166.9 cm
STANDARD_DEVIATION 8.6 • n=206 Participants
|
166.5 cm
STANDARD_DEVIATION 9.9 • n=7 Participants
|
|
BMI (kg/m^2)
|
38.0 kg/m^2
STANDARD_DEVIATION 8.7 • n=99 Participants
|
33.5 kg/m^2
STANDARD_DEVIATION 4.0 • n=107 Participants
|
22.9 kg/m^2
STANDARD_DEVIATION 1.8 • n=206 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 8.5 • n=7 Participants
|
PRIMARY outcome
Timeframe: Average over 6 weeksAn adherence score is calculated each week by summing 7 measurements of adherence and dividing by 21, the maximum score, with range from 0 (no adherence) to 1 (perfectly adherent). For each of the 7 measures a higher score means better adherence: \[1\] Attendance (0-2), \[2\] Food diaries (0-3), \[3\] 24-hour food recall via interview (0-3), \[4\] computer survey (0-3), \[5\] 24-hour food recall via interview (0-3), \[6\] Ecological momentary assessment (0-6), and \[7\] On time arrival for session (0-1). The final score is calculated as the average of the six weekly scores.
Outcome measures
| Measure |
Obese Underfeeding (UF)
n=19 Participants
Obese randomized to received a 35% calorie reduced diet
Underfeeding diet: Heart healthy diet with 35% reduced calories
|
Obese Weight Maintaining (WMEN)
n=18 Participants
Randomized to receive a weight-maintaining diet
Weight maintaining diet: Heart healthy weight-maintaining diet
|
Lean Weight Maintaining (WMEN)
n=23 Participants
Normal weight individuals receiving a weight-maintaining energy needs diet
Weight maintaining diet: Heart healthy weight-maintaining diet
|
|---|---|---|---|
|
Adherence Score
|
0.57 score on a scale
Standard Deviation 0.17
|
0.54 score on a scale
Standard Deviation 0.18
|
0.59 score on a scale
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: 6 weeksWeight loss from baseline, calculated as weight at 6 weeks - weight at baseline
Outcome measures
| Measure |
Obese Underfeeding (UF)
n=19 Participants
Obese randomized to received a 35% calorie reduced diet
Underfeeding diet: Heart healthy diet with 35% reduced calories
|
Obese Weight Maintaining (WMEN)
n=18 Participants
Randomized to receive a weight-maintaining diet
Weight maintaining diet: Heart healthy weight-maintaining diet
|
Lean Weight Maintaining (WMEN)
n=23 Participants
Normal weight individuals receiving a weight-maintaining energy needs diet
Weight maintaining diet: Heart healthy weight-maintaining diet
|
|---|---|---|---|
|
Change in Weight From Baseline to 6 Weeks
|
-3.14 kg
Standard Deviation 2.76
|
-1.64 kg
Standard Deviation 2.41
|
-0.54 kg
Standard Deviation 1.53
|
Adverse Events
Obese Underfeeding (UF)
Obese Weight Maintaining (WMEN)
Lean Weight Maintaining (WMEN)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Marci E. Gluck
National Institute of Diabetes Digestive and Kidney Diseases/NIH
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place