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NCT01862796 · ClinicalTrials.gov registry record · NA
Predicting Adherence to a Heart-Healthy Diet in Lean and Obese Individuals
A NA study of Obesity and Overweight, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT01862796: Completed NA study of Obesity and Overweight, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT01862796 is a NA study of Obesity and Overweight that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 100 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01862796, a NA study of Obesity and Overweight, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
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 h
Primary Outcome
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 sessi
Conditions Studied
Interventions
- BEHAVIORAL Underfeeding diet
- BEHAVIORAL Weight maintaining diet
Study Locations (1)
Arizona
- NIDDK, Phoenix - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2013-05-31 |
| Est. Completion | 2018-05-22 |
| Phase | NA |
What the finished NCT01862796 record still lists
NCT01862796 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Underfeeding diet is the first listed.
NCT01862796 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT01862796 about?
NCT01862796 is a clinical study titled "Predicting Adherence to a Heart-Healthy Diet in Lean and Obese Individuals". 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 wa...
What is the current status of trial NCT01862796?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2013-05-31. Estimated completion is 2018-05-22.
What conditions does trial NCT01862796 study?
This clinical trial studies the following conditions: Obesity, Overweight.
What interventions are being tested in trial NCT01862796?
The interventions under investigation include: Underfeeding diet (BEHAVIORAL), Weight maintaining diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT01862796?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01862796 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01862796's enrollment target sits among peer trials
100 478th of 1053 higher than 555 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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