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

NCT01862796 | Completed Results

• 2 other identifiers: 99991309613-DK-N096
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Obesity; Overweight

Keywords

Food Intake; Weight Loss; Compliance

Outcome Measures

Primary Outcomes (1)

• Adherence Score

  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.

  Average over 6 weeks

Secondary Outcomes (1)

• Change in Weight From Baseline to 6 Weeks

  6 weeks

Study Arms (3)

Obese underfeeding (UF)

EXPERIMENTAL

Obese randomized to received a 35% calorie reduced diet

Behavioral: Underfeeding diet

Obese weight maintaining (WMEN)

EXPERIMENTAL

Randomized to receive a weight-maintaining diet

Behavioral: Weight maintaining diet

Lean weight maintaining (WMEN)

EXPERIMENTAL

Normal weight individuals receiving a weight-maintaining energy needs diet

Behavioral: Weight maintaining diet

Interventions

Underfeeding diet BEHAVIORAL

Heart healthy diet with 35% reduced calories

Also known as: UF

Obese underfeeding (UF)

Weight maintaining diet BEHAVIORAL

Heart healthy weight-maintaining diet

Also known as: WMEN

Lean weight maintaining (WMEN); Obese weight maintaining (WMEN)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• Weight stable (plus or minus 2 percent) for last 3 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

NIDDK, Phoenix

Phoenix, Arizona, 85014, United States

Location

Related Publications (4)

• Fappa E, Yannakoulia M, Pitsavos C, Skoumas I, Valourdou S, Stefanadis C. Lifestyle intervention in the management of metabolic syndrome: could we improve adherence issues? Nutrition. 2008 Mar;24(3):286-91. doi: 10.1016/j.nut.2007.11.008. Epub 2008 Jan 16.

  PMID: 18201869 BACKGROUND

• Flegal KM, Graubard BI, Williamson DF, Gail MH. Weight-associated deaths in the United States. J Womens Health (Larchmt). 2007 Nov;16(9):1368-70. doi: 10.1089/jwh.2007.0547. No abstract available.

  PMID: 18001195 BACKGROUND

• Kassirer JP, Angell M. Losing weight--an ill-fated New Year's resolution. N Engl J Med. 1998 Jan 1;338(1):52-4. doi: 10.1056/NEJM199801013380109. No abstract available.

  PMID: 9414332 BACKGROUND

• Stinson EJ, Piaggi P, Votruba SB, Venti C, Lovato-Morales B, Engel S, Krakoff J, Gluck ME. Is Dietary Nonadherence Unique to Obesity and Weight Loss? Results From a Randomized Clinical Trial. Obesity (Silver Spring). 2020 Nov;28(11):2020-2027. doi: 10.1002/oby.23008.

  PMID: 32808484 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss; Patient Compliance

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Marci E. Gluck
• Organization: National Institute of Diabetes Digestive and Kidney Diseases/NIH

gmarci@mail.nih.gov

602-200-5317

Study Officials

• Marci Gluck, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: May 24, 2013
• Study Start: May 31, 2013
• Primary Completion: May 22, 2018
• Study Completion: May 22, 2018
• Last Updated: August 15, 2019
• Results First Posted: August 15, 2019

Record last verified: 2018-05-22

Locations

US (1)