Prepackaged Foods to Promote Weight Loss

NCT02136290 | Completed

• 2 other identifiers: 140047Nestle
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Overweight; Obese

Keywords

Weight loss

Outcome Measures

Primary Outcomes (1)

• Weight loss

  3 months

Study Arms (2)

Usual Care

OTHER

Weight loss counseling

Behavioral: Usual Care

Prepackaged meal

EXPERIMENTAL

Prepackaged meals

Behavioral: Prepackaged meals

Interventions

Prepackaged meals BEHAVIORAL

Portion-controlled prepackaged meals

Prepackaged meal

Usual Care BEHAVIORAL

Usual care dietary counseling

Usual Care

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Société des Produits Nestlé (SPN): collaborator

Study Sites (2)

University of California, San Diego, Moores Cancer Center

La Jolla, California, 92093, United States

Location

University of California, San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Cheryl L Rock, PhD, RD

  UC San Diego Moores Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: May 13, 2014
• Study Start: May 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 21, 2015

Record last verified: 2015-08

Locations

US (2)