Prepackaged Foods to Promote Weight Loss (CHOICES)

Randomized Clinical Trial of Portion-Controlled Prepackaged Foods to Promote Weight Loss - CHOICES Study.

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Obese
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: Prepackaged meals

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.

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California, San Diego
    • La Jolla, California, United States, 92093
      • University of California, San Diego, Moores Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual Care; Weight loss counseling	Behavioral: Usual Care; Usual care dietary counseling
Experimental: Prepackaged meal; Prepackaged meals	Behavioral: Prepackaged meals; Portion-controlled prepackaged meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight loss	3 months

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Cheryl L Rock, PhD, RD, UC San Diego Moores Cancer Center

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Estimate): August 21, 2015
• Last Update Submitted That Met QC Criteria: August 19, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Weight loss
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: 140047; Nestle (Registry Identifier: Nestle)