Food, Activity and Behavior Trial

NCT ID: NCT00640900

Last Updated: 2008-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overweight Obesity

Keywords

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overweight obesity weight loss commercial weight loss program

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Commercial program at center

Group Type EXPERIMENTAL

Commercial weight loss program

Intervention Type BEHAVIORAL

Active weekly participation until weight loss goals are reached, and monthly participation to maintain the weight loss.

Commercial program over the telephone

Group Type EXPERIMENTAL

Commercial weight loss program

Intervention Type BEHAVIORAL

Active weekly participation until weight loss goals are reached, and monthly participation to maintain the weight loss.

Usual care

Weight loss counseling

Group Type OTHER

Usual care

Intervention Type BEHAVIORAL

Two individualized weight loss counseling sessions with a dietetics professional, and monthly contacts to maintain communications.

Interventions

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Usual care

Two individualized weight loss counseling sessions with a dietetics professional, and monthly contacts to maintain communications.

Intervention Type BEHAVIORAL

Commercial weight loss program

Active weekly participation until weight loss goals are reached, and monthly participation to maintain the weight loss.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jenny Craig, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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University of California, San Diego

Principal Investigators

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Cheryl L Rock, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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University of California, San Diego

La Jolla, California, United States

Site Status

Countries

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United States

References

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Dow CA, Thomson CA, Flatt SW, Sherwood NE, Pakiz B, Rock CL. Predictors of improvement in cardiometabolic risk factors with weight loss in women. J Am Heart Assoc. 2013 Dec 18;2(6):e000152. doi: 10.1161/JAHA.113.000152.

Reference Type DERIVED
PMID: 24351700 (View on PubMed)

Thomson CA, Morrow KL, Flatt SW, Wertheim BC, Perfect MM, Ravia JJ, Sherwood NE, Karanja N, Rock CL. Relationship between sleep quality and quantity and weight loss in women participating in a weight-loss intervention trial. Obesity (Silver Spring). 2012 Jul;20(7):1419-25. doi: 10.1038/oby.2012.62. Epub 2012 Mar 8.

Reference Type DERIVED
PMID: 22402738 (View on PubMed)

Rock CL, Emond JA, Flatt SW, Heath DD, Karanja N, Pakiz B, Sherwood NE, Thomson CA. Weight loss is associated with increased serum 25-hydroxyvitamin D in overweight or obese women. Obesity (Silver Spring). 2012 Nov;20(11):2296-301. doi: 10.1038/oby.2012.57. Epub 2012 Mar 8.

Reference Type DERIVED
PMID: 22402737 (View on PubMed)

Rock CL, Flatt SW, Sherwood NE, Karanja N, Pakiz B, Thomson CA. Effect of a free prepared meal and incentivized weight loss program on weight loss and weight loss maintenance in obese and overweight women: a randomized controlled trial. JAMA. 2010 Oct 27;304(16):1803-10. doi: 10.1001/jama.2010.1503. Epub 2010 Oct 9.

Reference Type DERIVED
PMID: 20935338 (View on PubMed)

Other Identifiers

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20073396

Identifier Type: -

Identifier Source: org_study_id