ObesityNCT00827593
Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches
A study testing Standard behavioral weight loss treatment, Weight Watchers and Combined Treatment in people with Obesity, run by Baruch College City University of New York at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of 3 behavioral weight loss programs- Weight Watchers, university-based behavioral weight loss treatment, and a combined approach which includes university-based treatment followed by Weight Watchers. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Standard behavioral weight loss treatment, Weight Watchers and Combined Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Oct 2011
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 30-65 years
- BMI between 27-50 kg/m2
- Written approval/consent from primary health care provider
Who cannot join
- Unable to walk 2 blocks without stopping.
- Currently participating in a weight loss program or taking weight loss medication.
- Participated in a weight loss program in the last year
- Took weight loss medication in the last 6 months.
- Participated in Weight Watchers in last 2 years.
- Lost >=5% of body weight during 6 months prior to screening.
Show all 9Show fewer
- Pregnant, lactating, less than 6 months postpartum, or plan to become pregnant during study time frame.
- Report conditions that in the judgment of the principal investigator would render them potentially unlikely to follow protocol for the 12 month study.
- Report a medical condition that would affect the safety and/or efficacy of a weight management program involving changes in diet and physical activity.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the effectiveness of 3 behavioral weight loss programs- Weight Watchers, university-based behavioral weight loss treatment, and a combined approach which includes university-based treatment followed by Weight Watchers.
- Conditions
- Obesity
- Being tested
- Standard behavioral weight loss treatment, Weight Watchers, Combined Treatment
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard behavioral weight loss treatmentBehavioural
Participants will receive 12 months of university-based behavioral weight loss treatment
Weight WatchersBehavioural
Participants will receive 12 months of Weight Watchers
Combined TreatmentBehavioural
Participants will receive university-based behavioral weight loss treatment followed by Weight Watchers
| Study group | Role | What they receive |
|---|---|---|
| Standard behavioral weight loss | Active comparator | University-based behavioral weight loss treatment Receives: Behavioral: Standard behavioral weight loss treatment |
| Weight Watchers | Active comparator | Weight Watchers program Receives: Behavioral: Weight Watchers |
| Combined Treatment | Active comparator | University-based behavioral weight loss treatment followed by Weight Watchers Receives: Behavioral: Combined Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: 3, 6, 12 months
Secondary outcomes (1)
cost-effectiveness
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionApr 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baruch College City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela M Pinto, Baruch College City University of New York
- Investigators
- Angela M Pinto, PhD, Principal investigator, Baruch College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827593
- Sponsor's protocol ID
- 070601
- Status last verified
- Apr 2012
- First submitted
- 22 Jan 2009
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pinto AM, Fava JL, Hoffmann DA, Wing RR. Combining behavioral weight loss treatment and a commercial program: a randomized clinical trial. Obesity (Silver Spring). 2013 Apr;21(4):673-80. doi: 10.1002/oby.20044.
PubMed 23404824
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches
- ClinicalTrials.gov ID
- NCT00827593
- Acronym / sponsor ID
- 070601
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Baruch College City University of New YorkUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Nov 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Jan 2009 (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.
The purpose of this study is to examine the effectiveness of 3 behavioral weight loss programs- Weight Watchers, university-based behavioral weight loss treatment, and a combined approach which includes university-based treatment followed by Weight Watchers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard behavioral weight loss | Active comparator | Behavioral: Standard behavioral weight loss treatmentUniversity-based behavioral weight loss treatment |
| Weight Watchers | Active comparator | Behavioral: Weight WatchersWeight Watchers program |
| Combined Treatment | Active comparator | Behavioral: Combined TreatmentUniversity-based behavioral weight loss treatment followed by Weight Watchers |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 30-65 years
- BMI between 27-50 kg/m2
- Written approval/consent from primary health care provider
Key exclusion criteria (9 listed)
- Unable to walk 2 blocks without stopping.
- Currently participating in a weight loss program or taking weight loss medication.
- Participated in a weight loss program in the last year
- Took weight loss medication in the last 6 months.
- Participated in Weight Watchers in last 2 years.
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 |
|---|---|---|
| Standard behavioral weight loss treatmentParticipants will receive 12 months of university-based behavioral weight loss treatment | Behavioural | Standard behavioral weight loss |
| Weight WatchersParticipants will receive 12 months of Weight Watchers | Behavioural | Weight Watchers |
| Combined TreatmentParticipants will receive university-based behavioral weight loss treatment followed by Weight Watchers | Behavioural | Combined Treatment |
Primary outcome
weight loss
Time frame: 3, 6, 12 months
1 secondary outcome
cost-effectiveness
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2012.
- Derived from this study: PubMed 23404824Pinto AM, Fava JL, Hoffmann DA, Wing RR. Combining behavioral weight loss treatment and a commercial program: a randomized clinical trial. Obesity (Silver Spring). 2013 Apr;21(4):673-80. doi: 10.1002/oby.20044.
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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.
Angela M Pinto, PhD principal investigator
Baruch College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard behavioral weight loss treatment, Weight Watchers and Combined Treatment in people with Obesity, run by Baruch College City University of New York 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 13 Apr 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 3, 6, 12 months). 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 NCT00827593, which also lists 1 linked publication.
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 13 Apr 2012.