OverweightFABNCT00640900
Food, Activity and Behavior Trial
A study testing Commercial weight loss program in people with Overweight and Obesity, run by Jenny Craig, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Commercial weight loss program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: 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.
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.
- Conditions
- Overweight, Obesity
- Being tested
- Usual care, Commercial weight loss program
- Keywords
- overweight, obesity, weight loss, commercial weight loss program
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careBehavioural
Two individualized weight loss counseling sessions with a dietetics professional, and monthly contacts to maintain communications.
Commercial weight loss programBehavioural
Active weekly participation until weight loss goals are reached, and monthly participation to maintain the weight loss.
| Study group | Role | What they receive |
|---|---|---|
| Commercial program at center | Experimental | Not described Receives: Behavioral: Commercial weight loss program |
| Commercial program over the telephone | Experimental | Not described Receives: Behavioral: Commercial weight loss program |
| Usual care | Other | Weight loss counseling Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startJul 2007
- Primary completionJul 2009 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jenny Craig, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Cheryl L Rock, PhD, RD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640900
- Sponsor's protocol ID
- 20073396
- Acronym
- FAB
- Status last verified
- Mar 2008
- First submitted
- 18 Mar 2008
- Last updated
- 1 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
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 24351700Thomson 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 22402738Rock 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 22402737Rock 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Randomized Trial of a Commercial Weight Loss Program
- ClinicalTrials.gov ID
- NCT00640900
- Acronym / sponsor ID
- FAB / 20073396
- Conditions
- Overweight, Obesity
- Keywords
- overweight, obesity, weight loss, commercial weight loss program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Jenny Craig, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 21 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Commercial program at center | Experimental | Behavioral: Commercial weight loss program |
| Commercial program over the telephone | Experimental | Behavioral: Commercial weight loss program |
| Usual care | Other | Behavioral: Usual careWeight loss counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careTwo individualized weight loss counseling sessions with a dietetics professional, and monthly contacts to maintain communications. | Behavioural | Usual care |
| Commercial weight loss programActive weekly participation until weight loss goals are reached, and monthly participation to maintain the weight loss. | Behavioural | Commercial program at center, Commercial program over the telephone |
Primary outcome
weight loss
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2008.
- Derived from this study: PubMed 24351700Dow 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.
- Derived from this study: PubMed 22402738Thomson 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.
- Derived from this study: PubMed 22402737Rock 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.
- Derived from this study: PubMed 20935338Rock 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl L Rock, PhD, RD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercial weight loss program in people with Overweight and Obesity, run by Jenny Craig, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00640900, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2008.