Prepackaged Foods to Promote Weight Loss

Completed · Not applicable

Conditions studied: Overweight, Obese

In brief

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.

Key facts

Study ID

NCT02136290

Run by

University of California, San Diego

People needed

184

Starts

2014-05-01

Expected to finish

2015-03-01

Last updated by the study team

2015-08-21

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• overweight or obese men and women
• Aged 25-65 years
• initial BMI >27.0 kg/m2 and < 40 kg/m2
• no eating disorders, food allergies or intolerances
• no history of bariatric surgery
• willing and able to participate in clinic visits and study interactions at specified intervals
• maintain contact with the investigators for at least three months
• willing to allow blood collections
• capable of performing a simple test for assessing cardiopulmonary fitness

You may not qualify if…

• inability to participate in physical activity because of co-morbidity or disability (e.g., severe arthritic conditions);
• a history or presence of a comorbid disease for which diet modification and increased physical activity may be contraindicated or complicated;
• self-reported pregnancy or breastfeeding or planning a pregnancy within the next two years;
• currently actively involved in another diet intervention study or organized weight loss program;
• a history or presence of a significant psychiatric disorder or any other condition that, in the investigator's judgment, would interfere with participation in the trial.

Where it is running

• University of California, San Diego, Moores Cancer Center — La Jolla, California, United States
• University of California, San Diego — La Jolla, California, United States

Full record on ClinicalTrials.gov

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