Food, Activity and Behavior Trial

Obesity Clinical Trial

— FAB  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00640900
• Other study ID #: 20073396
• Status: Active, not recruiting
• Phase: N/A
• First received: March 18, 2008
• Last updated: March 31, 2008
• Start date: July 2007
• Est. completion date: July 2010

Study information

• Verified date: March 2008
• Source: Jenny Craig, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 440
• Est. completion date: July 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Usual care
Two individualized weight loss counseling sessions with a dietetics professional, and monthly contacts to maintain communications.
• Commercial weight loss program
Active weekly participation until weight loss goals are reached, and monthly participation to maintain the weight loss.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Jenny Craig, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss		2 year	No