Trial Outcomes & Findings for Predicting Adherence to a Heart-Healthy Diet in Lean and Obese Individuals (NCT 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

Average over 6 weeks

Results posted on

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

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

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

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=5 Participants	49.8 years STANDARD_DEVIATION 13.1 • n=7 Participants	49.7 years STANDARD_DEVIATION 12.5 • n=5 Participants	48.3 years STANDARD_DEVIATION 14.1 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	23 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethniticy · American Indian or Alaskan Native	7 Participants n=5 Participants	8 Participants n=7 Participants	1 Participants n=5 Participants	16 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethniticy · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethniticy · Native Hawaiian of Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethniticy · Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethniticy · Hispanic/Latino	2 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethniticy · Caucasian	9 Participants n=5 Participants	3 Participants n=7 Participants	17 Participants n=5 Participants	29 Participants n=4 Participants
Region of Enrollment United States	19 participants n=5 Participants	18 participants n=7 Participants	23 participants n=5 Participants	60 participants n=4 Participants
Weight, kg	111.0 kg STANDARD_DEVIATION 29.1 • n=5 Participants	88.1 kg STANDARD_DEVIATION 15.3 • n=7 Participants	63.9 kg STANDARD_DEVIATION 8.0 • n=5 Participants	86.1 kg STANDARD_DEVIATION 27.3 • n=4 Participants
Height, cm	170.5 cm STANDARD_DEVIATION 10.4 • n=5 Participants	161.7 cm STANDARD_DEVIATION 9.4 • n=7 Participants	166.9 cm STANDARD_DEVIATION 8.6 • n=5 Participants	166.5 cm STANDARD_DEVIATION 9.9 • n=4 Participants
BMI (kg/m^2)	38.0 kg/m^2 STANDARD_DEVIATION 8.7 • n=5 Participants	33.5 kg/m^2 STANDARD_DEVIATION 4.0 • n=7 Participants	22.9 kg/m^2 STANDARD_DEVIATION 1.8 • n=5 Participants	30.9 kg/m^2 STANDARD_DEVIATION 8.5 • n=4 Participants

PRIMARY outcome

Timeframe: Average over 6 weeks

Outcome measures

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 weeks

Weight loss from baseline, calculated as weight at 6 weeks - weight at baseline

Outcome measures

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)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Obese Weight Maintaining (WMEN)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lean Weight Maintaining (WMEN)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Phone: 602-200-5317

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place