CClinicalTrials.gg
Status unknownNCT00640900FABUpdated Apr 1, 2008

Food, Activity and Behavior Trial

An interventional study of Usual care and Commercial weight loss program in Overweight and Obesity, sponsored by Jenny Craig, Inc.. Status unknown at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-04-01.

Sponsored by Jenny Craig, Inc. · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2008), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
440
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Overweight
  • Obesity

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Keywords

  • overweight
  • obesity
  • weight loss
  • commercial weight loss program
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In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's planned enrollment of 440 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Jenny Craig, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
440 participants (estimated)

Study arms

  • Experimental
    Commercial program at center

    Behavioral: Commercial weight loss program

  • Experimental
    Commercial program over the telephone

    Behavioral: Commercial weight loss program

  • Other
    Usual care

    Weight loss counseling

    Behavioral: Usual care

Interventions

  • BehavioralUsual care

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

  • BehavioralCommercial weight loss program

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

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What researchers measure

Primary outcomes

  1. weight loss

    Time frame: 2 year

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Study locations

1 site
  • University of California, San Diego
    La Jolla, California 92093, United States
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References and documents

Publications

  • 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. PubMed 24351700 ↗
  • 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. PubMed 22402738 ↗
  • 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. PubMed 22402737 ↗
  • 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. PubMed 20935338 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00640900
Lead sponsor
Jenny Craig, Inc.
First posted
Mar 21, 2008
Start date
Jul 2007
Primary completion
Jul 2009 (estimated)
Completion
Jul 2010 (estimated)
Last update
Apr 1, 2008

Study contacts

Cheryl L Rock, PhD, RD
principal investigator · UCSD

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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