An interventional study of Prepackaged meals and Usual Care in Overweight and Obese, sponsored by University of California, San Diego. Completed at 2 sites in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-21.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Prevention
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.
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 184 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Exclusion Criteria:
Weight loss counseling
Behavioral: Usual Care
Prepackaged meals
Behavioral: Prepackaged meals
Portion-controlled prepackaged meals
Usual care dietary counseling
Weight loss
Time frame: 3 months
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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University of California, San Diego