Considering Patient Diet Preferences to Optimize Weight Loss

NCT01152359 | Completed Results

• 1 other identifier: IIR 09-381
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is increasingly common and can lead to decreased quality of life, increased medical and psychiatric illness, high health care costs, and early mortality. The problem of obesity is as great in veterans as it is in the general public. Adherence to dietary therapy for obesity is often inadequate, possibly because patients' food preferences are not considered during dietary counseling. Allowing patients to choose a diet based on their food preferences may increase their motivation to adhere to diet counseling. This, in turn, could enhance their weight loss success and, ultimately, reduce the many health complications and costs of obesity. The proposed study will examine whether assessing a person's food preferences, and then allowing the person to choose from two commonly prescribed diets, results in greater weight loss success.

Conditions

Obesity

Keywords

obesity; diet, low carbohydrate; diet, fat-restricted; food preferences; quality of life; patient compliance

Outcome Measures

Primary Outcomes (1)

• Percent Change in Body Weight From Baseline to 48 Weeks

  Baseline, 48 weeks

Secondary Outcomes (2)

• Diet Adherence as Measured by Block Food-frequency Questionnaire (Absolute Percentage Deviation From the Goal Macronutrient Intake--<30% Fat for Low-fat Diet or <10% Carbohydrate for Low-carbohydrate Diet)

  48 weeks

• Change in Obesity-specific Health-related Quality of Life as Measured by Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire From Baseline to 48 Weeks

  Baseline, 48 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Participants are allowed to choose between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and their food preferences (Choice arm). Then they receive counseling on their chosen diet in a small group format. The low-carbohydrate diet limits carbohydrate intake to 20-40 grams/day initially. The low-fat diet restricts saturated fat to below 30% of daily calories and has a 500-1000 calorie deficit. Group sessions are every 2 weeks for 24 weeks then alternate with telephone calls every 2 weeks for 24 weeks. Phone calls focus on goal setting to maximize weight loss. Participants also receive counseling on behavioral techniques and physical activity. Participants in this arm have the option to switch diets at 12 weeks.

Behavioral: Choice

Arm 2

ACTIVE COMPARATOR

Participants are randomly assigned to (rather than getting to choose, as in the experimental arm) a low-carbohydrate or a low-fat diet for weight loss (Control arm). Then they receive counseling on their chosen diet in a small group format. The low-carbohydrate diet limits carbohydrate intake to 20-40 grams/day initially. The low-fat diet restricts saturated fat to below 30% of daily calories and has a 500-1000 calorie deficit. Group sessions are every 2 weeks for 24 weeks then alternate with telephone calls every 2 weeks for 24 weeks. Phone calls focus on goal setting to maximize weight loss. Participants also receive counseling on behavioral techniques and physical activity. Participants in this arm do not have the option to switch diets at 12 weeks.

Behavioral: Control

Interventions

Choice BEHAVIORAL

Participants are allowed to choose between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and their food preferences (Choice arm). Then they receive counseling on their chosen diet in a small group format. The low-carbohydrate diet limits carbohydrate intake to 20-40 grams/day initially. The low-fat diet restricts saturated fat to below 30% of daily calories and has a 500-1000 calorie deficit. Group sessions are every 2 weeks for 24 weeks then alternate with telephone calls every 2 weeks for 24 weeks. Phone calls focus on goal setting to maximize weight loss. Participants also receive counseling on behavioral techniques and physical activity. Participants in this arm have the option to switch diets at 12 weeks.

Arm 1

Control BEHAVIORAL

Participants are randomly assigned to (rather than getting to choose, as in the experimental arm) a low-carbohydrate or a low-fat diet for weight loss (Control arm). Then they receive counseling on their chosen diet in a small group format. The low-carbohydrate diet limits carbohydrate intake to 20-40 grams/day initially. The low-fat diet restricts saturated fat to below 30% of daily calories and has a 500-1000 calorie deficit. Group sessions are every 2 weeks for 24 weeks then alternate with telephone calls every 2 weeks for 24 weeks. Phone calls focus on goal setting to maximize weight loss. Participants also receive counseling on behavioral techniques and physical activity. Participants in this arm do not have the option to switch diets at 12 weeks.

Arm 2

Eligibility Criteria

• Age: Up to 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index 30 or greater
• Stable health
• Desire to lose weight
• Agrees to attend regular visits
• Access to telephone and reliable transportation
• Has a Veterans Affairs Medical Center (VAMC) provider

You may not qualify if:

• Certain chronic or unstable disease (kidney or liver disease, type 1 diabetes, hemoglobin A1c 12% or more, insulin use, unstable heart disease, transplant recipient, blood pressure 160/100 or greater, fasting blood triglycerides 600 or greater, LDL cholesterol 190 or greater)
• Pregnancy, breastfeeding, lack of birth control
• Active dementia, psychiatric illness, or substance abuse (past year)
• Weight loss therapy in previous month
• Pacemaker or defibrillator
• Enrolled in another study that might affect measurements
• Previously in study of low-carbohydrate or low-fat diet for weight loss
• Unable to complete all study measures

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (9)

• McVay MA, Yancy WS Jr, Vijan S, Van Scoyoc L, Neelon B, Voils CI, Maciejewski ML. Obesity-related health status changes and weight-loss treatment utilization. Am J Prev Med. 2014 May;46(5):465-72. doi: 10.1016/j.amepre.2013.11.018.

  PMID: 24745636 BACKGROUND

• Yancy WS. Peer Support Significantly Improves Compliance in Veterans with Diabetes. U. S. Medicine. 2012 Nov 20.

  BACKGROUND

• Yancy WS Jr, McVay MA, Brinkworth GD. Adherence to diets for weight loss. JAMA. 2013 Dec 25;310(24):2676. doi: 10.1001/jama.2013.282639. No abstract available.

  PMID: 24368474 RESULT

• McVay MA, Jeffreys AS, King HA, Olsen MK, Voils CI, Yancy WS Jr. The relationship between pretreatment dietary composition and weight loss during a randomised trial of different diet approaches. J Hum Nutr Diet. 2015 Feb;28 Suppl 2:16-23. doi: 10.1111/jhn.12188. Epub 2013 Nov 20.

  PMID: 24251378 RESULT

• McVay MA, Voils CI, Coffman CJ, Geiselman PJ, Kolotkin RL, Mayer SB, Smith VA, Gaillard L, Turner MJ, Yancy WS Jr. Factors associated with choice of a low-fat or low-carbohydrate diet during a behavioral weight loss intervention. Appetite. 2014 Dec;83:117-124. doi: 10.1016/j.appet.2014.08.023. Epub 2014 Aug 19.

  PMID: 25149197 RESULT

• Yancy WS Jr, Coffman CJ, Geiselman PJ, Kolotkin RL, Almirall D, Oddone EZ, Mayer SB, Gaillard LA, Turner M, Smith VA, Voils CI. Considering patient diet preference to optimize weight loss: design considerations of a randomized trial investigating the impact of choice. Contemp Clin Trials. 2013 May;35(1):106-16. doi: 10.1016/j.cct.2013.03.002. Epub 2013 Mar 16.

  PMID: 23506974 RESULT

• Yancy WS Jr, Mayer SB, Coffman CJ, Smith VA, Kolotkin RL, Geiselman PJ, McVay MA, Oddone EZ, Voils CI. Effect of Allowing Choice of Diet on Weight Loss: A Randomized Trial. Ann Intern Med. 2015 Jun 16;162(12):805-14. doi: 10.7326/M14-2358.

  PMID: 26075751 RESULT

• Yancy WS Jr, McVay MA, Voils CI. Effect of allowing choice of diet on weight loss--in response. Ann Intern Med. 2015 Nov 17;163(10):805-6. doi: 10.7326/L15-5159. No abstract available.

  PMID: 26571246 RESULT

• McVay MA, Voils CI, Geiselman PJ, Smith VA, Coffman CJ, Mayer S, Yancy WS Jr. Food preferences and weight change during low-fat and low-carbohydrate diets. Appetite. 2016 Aug 1;103:336-343. doi: 10.1016/j.appet.2016.04.035. Epub 2016 Apr 29.

  PMID: 27133551 RESULT

MeSH Terms

Conditions

Obesity; Food Preferences; Patient Compliance

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: William S. Yancy, Jr.
• Organization: VA Medical Center

william.yancy2@va.gov

919-286-0411

Study Officials

• William S. Yancy, MD MHS

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 29, 2010
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 12, 2019
• Results First Posted: October 22, 2014

Record last verified: 2019-01

Locations

US (1)