Considering Patient Diet Preferences to Optimize Weight Loss (Diet Choice)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01152359
First received: June 14, 2010
Last updated: October 17, 2014
Last verified: October 2014

June 14, 2010
October 17, 2014
May 2011
May 2013   (final data collection date for primary outcome measure)
Body Weight [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01152359 on ClinicalTrials.gov Archive Site
  • 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) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Obesity-specific Health-related Quality of Life as Measured by Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • obesity-specific health-related quality of life as measured by IWQOL-Lite [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Considering Patient Diet Preferences to Optimize Weight Loss
Considering Patient Diet Preference to Optimize Weight Loss

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.

The prevalence of obesity (body mass index [BMI] 30 kg/m2) in US adults has skyrocketed over the past 30 years, and is currently as high or higher in veterans as it is in non-veterans. Thus, identifying effective strategies for treating obesity is both a public health and a VA priority. A variety of diet approaches have proven successful in achieving moderate weight loss in many individuals. Yet, most diet interventions fail to achieve meaningful weight loss in more than a few individuals. This failure likely results from inadequate adherence to the diet.

It is widely felt, but not empirically shown, that targeting the diet to an individual's food preferences will enhance adherence, thereby improving weight loss outcomes. This study will test the commonly proposed assumption that helping patients choose a diet based on their dietary preferences will increase weight loss success relative to assigning or recommending one diet.

The proposed study is a 2-arm randomized controlled trial involving 216 outpatients from Durham VA Medical Center. Participants must be obese (BMI 30 kg/m) VAMC outpatients without unstable health issues. Participants in the experimental arm (Choice) will select from two of the most widely studied diets for weight loss, either a low-carbohydrate, calorie-unrestricted diet (LCD) or a low-fat, reduced-calorie diet (LFD). This choice will be informed by results from a validated food preference questionnaire and a discussion of available diet options with trained personnel. As may occur in the clinical setting, the Choice participants will also have the opportunity to switch to the other diet after 3 months if unsuccessful or dissatisfied with their primary selection. The Choice intervention is designed to enhance the three psychological needs of a person according to self-determination theory (SDT): competence, relatedness, and, in particular, autonomy. This should maximize intrinsic motivation, thereby improving adherence to diet recommendations and increasing weight loss. Participants in the Control arm will be randomly assigned to follow one of the two diets for the duration of follow-up.

All participants will receive diet-appropriate counseling in small group meetings every 2 weeks for 24 weeks, then monthly for another 24 weeks. All participants will also receive brief telephone counseling involving individual goal setting and problem solving halfway through each month in the latter 24 weeks. The primary outcome is weight change from baseline to 48 weeks. Secondary outcomes include adherence to diet by food frequency questionnaire and obesity-specific health-related quality of life. Exploratory analyses will examine whether the impact of choice versus lack of choice on weight loss is moderated by individual differences in the SDT constructs of autonomy orientation, competence, and relatedness.

If assisting patients to choose their diet enhances adherence and increases weight loss, the results will support the provision of diet options to veterans and non-veterans alike, and bring us one step closer to remediating the obesity epidemic faced by the VA and other healthcare systems.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • Behavioral: Choice
    Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. The low-carbohydrate diet will limit carbohydrate intake to 20-40 grams/day initially. The low-fat diet will restrict saturated fat to below 30% of daily calories and total energy intake to 500-1000 calories below maintenance level. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
  • Behavioral: Control
    Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. The low-carbohydrate diet will limit carbohydrate intake to 20-40 grams/day initially. The low-fat diet will restrict saturated fat to below 30% of daily calories and total energy intake to 500-1000 calories below maintenance level. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
  • Experimental: Arm 1
    Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. The low-carbohydrate diet will limit carbohydrate intake to 20-40 grams/day initially. The low-fat diet will restrict saturated fat to below 30% of daily calories and total energy intake to 500-1000 calories below maintenance level. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
    Intervention: Behavioral: Choice
  • Active Comparator: Arm 2
    Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. The low-carbohydrate diet will limit carbohydrate intake to 20-40 grams/day initially. The low-fat diet will restrict saturated fat to below 30% of daily calories and total energy intake to 500-1000 calories below maintenance level. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
    Intervention: Behavioral: Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
August 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
up to 74 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01152359
IIR 09-381
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: William S. Yancy, MD MHS Durham VA Medical Center HSR&D COE
Department of Veterans Affairs
October 2014

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