NCT01862796

Predicting Adherence to a Heart-Healthy Diet in Lean and Obese Individuals

Completed NA Results posted Last updated 15 August 2019

What this trial tests

NA trial testing Underfeeding diet in Obesity in 100 participants. Completed in 22 May 2018.

Timeline

31 May 2013

Primary endpoint
22 May 2018

22 May 2018

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	31 May 2013
Primary completion	22 May 2018
Estimated completion	22 May 2018
Sites	1 location across United States

Drugs / interventions tested

• Underfeeding diet
• Weight maintaining diet

Conditions studied

• Obesity — all drugs for Obesity →
• Overweight — all drugs for Overweight →

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who can join

Adults 18 to 70, any sex, with Obesity or Overweight. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adherence Score Primary · Average over 6 weeks

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.

Group	Value	95% CI
Obese Underfeeding (UF)	0.57	± 0.17
Obese Weight Maintaining (WMEN)	0.54	± 0.18
Lean Weight Maintaining (WMEN)	0.59	± 0.10

Change in Weight From Baseline to 6 Weeks Secondary · 6 weeks

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

Group	Value	95% CI
Obese Underfeeding (UF)	-3.14	± 2.76
Obese Weight Maintaining (WMEN)	-1.64	± 2.41
Lean Weight Maintaining (WMEN)	-0.54	± 1.53

Sponsor's own description

Background:

\- Sticking to a diet plan can be difficult, but is important for many different health reasons. Some people seem to have a harder time following and sticking to a diet plan than others. It is not clear whether people of different weights (lean or obese) might have differences in the way they adhere to diet plans. Researchers want to study three different groups of people based on their body mass index (BMI), which measures people based on their weight and height. The study will place the participants on a 6-week diet and see how well they follow the diet. The information from this study may help develop better weight-loss plans and healthy diet ideas.

Objectives:

* To understand what factors affect adherence to a diet plan.
* To collect information for future studies that may improve people's ability to stick to diets.

Eligibility:

\- Individuals at least 18 years of age who are lean (BMI between 18.5 and 25) or obese (BMI greater than 30).

Design:

* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will have a full-body scan to measure fat and muscle. They will also answer questions on eating behaviors, mood, and desire to change eating patterns.
* Participants will be separated into three groups. Each group will have a different diet. The lean group will have a heart-healthy diet designed to maintain the same weight. One of the obese groups will also have a heart-healthy diet designed to maintain the same weight. The other obese group will have a heart-healthy weight loss diet. In all groups, all food will be provided by the study doctors. Participants should not eat any food other than that provided for the study.
* Everyone will start with a 1-week food testing period to find the right number of calories for each group. After this first week, participants will attend one diet counseling session per week and will be contacted randomly once a week to check on the foods they have had in the past 24 hours. Participants will complete daily food diaries on paper as well as daily food records using a smart phone.
* Participants will come to the clinic twice a week to pick up the diet food. On one of those days, they will also have their counseling session.
* The study will last for 6 weeks. At the final study visit, participants will repeat the tests from the screening study.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Is Dietary Nonadherence Unique to Obesity and Weight Loss? Results From a Randomized Clinical Trial.
   Stinson EJ, Piaggi P, Votruba SB, Venti C, et al · · 2020 · cited 10× · PMID 32808484 · DOI 10.1002/oby.23008
2. Dietary Adherence Is Associated with Perceived Stress, Anhedonia, and Food Insecurity Independent of Adiposity.
   Booker JM, Cabeza de Baca T, Treviño-Alvarez AM, Stinson EJ, et al · · 2024 · cited 4× · PMID 38398850 · DOI 10.3390/nu16040526
3. Food insecurity moderates the relationship between momentary affect and adherence in a dietary intervention study.
   Andersen CC, Cabeza de Baca T, Votruba SB, Stinson EJ, et al · · 2022 · cited 4× · PMID 35088549 · DOI 10.1002/oby.23335