Obesity Clinical Trial
Official title:
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.
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