Food, Activity and Behavior Trial (FAB)

March 31, 2008 updated by: Jenny Craig, Inc.

A Multi-Site Randomized Trial of a Commercial Weight Loss Program

This study will provide data on the response over 24 months to two commercial weight loss programs (center-based and telephone-based) compared to control conditions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The first study aim is to test, in a randomized controlled trial, whether participation in the multifaceted traditional center-based commercial weight loss intervention program and/or the telephone-delivered commerical program is associated with a greater degree of weight loss at six, 12, and 18 months and whether weight loss is maintained over a 24-month period in overweight or obese women, compared to usual care or control conditions. This study utilizes a randomized study design with subjects assigned to the center-based weight loss program, telephone-delivered program, or a usual care control group. The second study aim is to describe the effect of participation in the weight loss programs (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), insulin, glucose, leptin, C-reactive protein, and vitamin D, and cardiopulmonary fitness. The center-based intervention involves in-person counseling and obtaining food items from the center, whereas the telephone-delivered program involves telephone counseling with food delivered to the home every two weeks.

Secondary aims of this study involve describing the characteristics associated with greater weight loss and maintenance in each of the two intervention arms. The hypothesis to be tested is that selected participant characteristics, such as older or younger age, might be differentially associated with greater success across the two types of programs and approaches.

Notably, the results of this study would contribute valuable data to the scientific knowledge base regarding the various modalities of communication for behavioral interventions (in-person versus telephone counseling). This is an important issue currently being considered and debated among clinical and community-based behavioral and nutritional scientists whose intervention efforts focus on promoting behavior change and positive effects on health-related outcomes such as weight reduction.

Study Type

Interventional

Enrollment (Anticipated)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Aged 18 years and older
  • Initial BMI >25.0 kg/m2 and <40 kg/m2
  • A minimum of 15 kg over ideal weight as defined by the 1983 Metropolitan Life Insurance tables
  • Willing and able to participate in clinic visits and JC facility interactions at specified intervals and to maintain contact with the investigators for 24 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 severe disability (e.g., severe arthritic conditions)
  • A history or presence of a comorbid diseases for which diet modification and increased physical activity may be contraindicated
  • 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
  • Having 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Commercial program at center
Behavioral: Commercial weight loss program
Active weekly participation until weight loss goals are reached, and monthly participation to maintain the weight loss.
EXPERIMENTAL: Commercial program over the telephone
Behavioral: Commercial weight loss program
Active weekly participation until weight loss goals are reached, and monthly participation to maintain the weight loss.
OTHER: Usual care
Weight loss counseling
Behavioral: Usual care
Two individualized weight loss counseling sessions with a dietetics professional, and monthly contacts to maintain communications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight loss
Time Frame: 2 year
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jenny Craig, Inc.

Investigators

  • Principal Investigator: Cheryl L Rock, PhD, RD, UCSD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ANTICIPATED)

July 1, 2009

Study Completion (ANTICIPATED)

July 1, 2010

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 18, 2008

First Posted (ESTIMATE)

March 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 1, 2008

Last Update Submitted That Met QC Criteria

March 31, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20073396

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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