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

This study is currently recruiting participants.
Verified May 19, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01862796
First Posted: May 24, 2013
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
May 23, 2013
May 24, 2013
October 19, 2017
May 31, 2013
March 1, 2018   (Final data collection date for primary outcome measure)
  • Adherence [ Time Frame: Weekly and at 6 wks ]
  • Weight Loss [ Time Frame: Weekly and at 6 wks ]
Examine differences in dietary adherence between lean and obese individuals [ Time Frame: 6 weeks ]
Complete list of historical versions of study NCT01862796 on ClinicalTrials.gov Archive Site
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Predicting Adherence to a Heart-Healthy Diet in Lean and Obese Individuals
Is Non-Adherence Unique to Weight-Loss? Predictors of Adherence to a Heart-Healthy Diet in Lean vs. 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 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.

Adherence, or "sticking to your diet" is important for successful initial weight loss and keeping off the weight over the long term (1). While early behavioral and dietary adherence have been associated with greater weight loss, sticking to a diet plan is difficult. It is not clear if adherence to any diet plan (even one which does not produce weight loss) is hard or whether people who are overweight have more difficulty with adhering to diet plans compared to people who are relatively lean.

<TAB><TAB>The main aim of this study is to evaluate dietary adherence in 3 groups of individuals participating in a 6-week heart-healthy dietary intervention program. Two groups [1 (BMI < 25 kg/m(2)) and 2. Obese (BMI greater than or equal to 30 kg/m(2))] will receive a heart-healthy diet designed to maintain their weight, and the third group [3. Obese] will be given a heart-healthy diet that is 35% less than their daily calorie needs to lose weight. Participants will attend one counseling session per week and will be contacted randomly 1x/week by study staff for completion of a 24-hour dietary recall. They will complete daily food diaries and daily records using smart-phones. Prior to starting the assigned heart-healthy dietary intervention, participants will complete questionnaires that include questions about how motivated they are to follow a diet, lose weight, and change eating patterns. These findings may help us understand what factors affect adherence, and help us design weight loss studies that improve people's ability to stick to diet interventions.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Obesity
  • Overweight
  • Behavioral: Weight Loss
    Participants receive either a weight-maintaining diet or a 35% calorie reduced diet
  • Behavioral: Weight Loss
    6-week heart-healthy dietary intervention; 35% calorie reduced diet
  • Behavioral: Food Intake
    6-week heart-healthy dietary intervention; 35% calorie reduced diet
  • Experimental: Obese
    Obese randomized to received a 35% calorie reduced diet
    Interventions:
    • Behavioral: Weight Loss
    • Behavioral: Weight Loss
  • Experimental: Obese: WMEN
    Randomized to receive a weight-maintaing diet
    Interventions:
    • Behavioral: Weight Loss
    • Behavioral: Weight Loss
  • Experimental: Lean
    Normal weight individuals receiving a weight-maintaining energy needs diet
    Intervention: Behavioral: Food Intake

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
March 1, 2018
March 1, 2018   (Final data collection date for primary outcome measure)

-INCLUSION CRITERIA:

  1. BMI

    • BMI greater than or equal to 30 kg/m(2) for the obese WMEN and UF groups but body weight less than 350 pounds to accommodate the DXA scanner
    • BMI less than or equal to 25 kg/m(2) (and BMI greater than or equal to 18.5 kg/m(2)) for the lean WMEN group
  2. Age greater than or equal to 18 years. Minors under the age of 18 will be excluded because growth and pubertal issues are significant parameters that could affect our outcomes and also because the time requirements of the study are such that they would interfere with school schedules. Participants must be healthy, as determined by medical history, physical examination, and laboratory tests.
  3. Weight stable (plus or minus 2 percent) for last 3 months

EXCLUSIION CRITERIA:

Candidates will be screened by phone to exclude those with BMI greater than or equal to 26 kg/m(2) and BMI less than or equal to 29 kg/m(2), significant health problems, including cancer, hypertension, diabetes, current and past 3-month use of certain prescribed medications, especially those that could affect body weight, such as antidepressants and stimulants as well as smoking, or excess alcohol (greater than 3 drinks/d). Women must not be pregnant or lactating, and be at least 1 year postpartum. Candidates with a history of psychotic disorder or hospitalization for psychiatric illness within the past 1 year will not be eligible. They will need to be weight stable for the past 3 months (plus or minus 2 percent) and cannot be in treatment for obesity or currently receiving psychotherapy. Individuals who meet criteria according to the phone screen will be invited to come to the unit for a screening visit and their screening sheets are placed in a locked filing cabinet. Forms from potential volunteers who are ineligible are shredded.

Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact: Marci Gluck, Ph.D. (602) 200-5312 gmarci@mail.nih.gov
United States
 
 
NCT01862796
999913096
13-DK-N096
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National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Marci Gluck, Ph.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health Clinical Center (CC)
May 19, 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP