Prepackaged Foods to Promote Weight Loss
Condition: Overweight; Obese
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The primary goal of this clinical trial is to examine whether provision of portion-controlled
      prepackaged foods in the context of a reduced-energy diet prescription and counseling is
      associated with a greater degree of weight loss at three months in overweight or obese men
      and women, compared to usual care or control conditions in which the prescribed
      reduced-energy diet is to be consumed via self-selected foods. The effect on body weight and
      recognized indicators of disease risk, diet quality and cardiopulmonary fitness, as well as
      meal satiety and satisfaction, will also be examined. Participants are 184 overweight or
      obese men and women in San Diego area who will be randomly assigned to usual care or control
      conditions.
    

Detailed description: 
      The first study aim is (1) to test, in a randomized controlled trial, whether provision of
      portion-controlled prepackaged lunch and dinner entrees in the context of a reduced-energy
      diet prescription and counseling is associated with a greater degree of weight loss at 12
      weeks in overweight or obese men and women, compared to usual care or control conditions in
      which the prescribed reduced-energy diet is to be consumed via self-selected foods. This
      study utilizes a randomized study design with participants assigned to the prepackaged food
      intervention arms or a usual care control group. The second study aim is (2) to describe the
      effect of participation in the prepackaged food arms (versus control conditions) on
      circulating lipids (fasting total plasma cholesterol and triglycerides, low-density
      lipoprotein [LDL] cholesterol, and high-density lipoprotein [HDL] cholesterol), carotenoids
      (a biomarker of vegetable and fruit intake), C-reactive protein, and cardiopulmonary fitness.

      Secondary aims of this study are (3) to describe the association between prepackaged food
      consumption on meal satiety, eating attitudes and behavior, and meal satisfaction. The
      hypothesis to be tested is that eating a reduced-energy diet that incorporates unit-defined,
      prepackaged foods is associated with meal satiety and satisfaction that is superior to a diet
      based on self-selected foods.

      As an exploratory aim, we also will examine whether there is a differential response to
      different dietary macronutrient composition in the prepackaged food items used in the
      structured meal plan in intervention participants. Lean Cuisine meal products will be offered
      to participants assigned to one intervention group, and only Lean Cuisine items with protein
      contributing >25% energy will be offered to participants in the other intervention group.

      Notably, the results of this study may contribute valuable data to the scientific knowledge
      base regarding the various aspects of diet and diet composition that may promote more
      successful weight loss. How diet can be best modified to promote weight loss is an important
      issue currently being considered and debated among clinical and community-based behavioral
      and nutritional scientists, and the optimal composition for weight loss diets has not been
      established (IOM 2002). Adherence to any dietary regimen and energy imbalance is a central
      determinant of successful weight loss, and evidence-based approaches that may promote better
      adherence with less deprivation and more meal satisfaction could help public health and
      clinical efforts to reduce the high prevalence of overweight and obesity in the U.S. today.
    

Intervention name(s): Prepackaged meals; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Portion-controlled prepackaged meals; Usual care dietary counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Weight loss