Food, Activity and Behavior Trial (FAB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Jenny Craig, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Jenny Craig, Inc.
ClinicalTrials.gov Identifier:
NCT00640900
First received: March 18, 2008
Last updated: March 31, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention
Overweight
Obesity
Behavioral: Usual care
Behavioral: Commercial weight loss program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Multi-Site Randomized Trial of a Commercial Weight Loss Program

Resource links provided by NLM:


Further study details as provided by Jenny Craig, Inc.:

Primary Outcome Measures:
  • weight loss [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: July 2007
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Usual care
Weight loss counseling
Behavioral: Usual care
Two individualized weight loss counseling sessions with a dietetics professional, and monthly contacts to maintain communications.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640900

Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
Jenny Craig, Inc.
Investigators
Principal Investigator: Cheryl L Rock, PhD, RD UCSD
  More Information

No publications provided by Jenny Craig, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Cheryl Rock, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00640900     History of Changes
Other Study ID Numbers: 20073396
Study First Received: March 18, 2008
Last Updated: March 31, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Jenny Craig, Inc.:
overweight
obesity
weight loss
commercial weight loss program

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014