ObesityNCT00716027
Applying Social Comparison Theory to Behavioral Weight Loss: Does Modifying Group Membership Improve Outcome?
A study testing Standard behavioral treatment for weight loss and Modified behavioral treatment for weight loss in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a modified behavioral treatment for weight loss that includes one-on-one treatment for individuals struggling to lose weight is associated with more weight loss than a standard behavioral treatment. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Standard behavioral treatment for weight loss and Modified behavioral treatment for weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Mar 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI between 27 and 45 kg/m2
Who cannot join
- participating in a weight loss program or taking a weight loss medication
- currently pregnant, lactating, or less than 6-months post-partum or plan to become pregnant during the time of the intervention.
- report a heart condition, chest pain during periods of activity or rest, or loss of consciousness
- report conditions that would render the participant unlikely to follow the study protocol (e.g., terminal illness, relocation, substance abuse, sever psychiatric condition, dementia).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether a modified behavioral treatment for weight loss that includes one-on-one treatment for individuals struggling to lose weight is associated with more weight loss than a standard behavioral treatment.
- Conditions
- Obesity
- Being tested
- Standard behavioral treatment for weight loss, Modified behavioral treatment for weight loss
- 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 treatment for weight lossBehavioural
A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity.
Modified behavioral treatment for weight lossBehavioural
A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity. In this intervention, individuals not meeting weight loss goals will be given one-on-one treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity. Receives: Behavioral: Standard behavioral treatment for weight loss |
| 2 | Experimental | A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity. In this intervention, individuals not meeting weight loss goals will be given one-on-one treatment. Receives: Behavioral: Modified behavioral treatment for weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
Measured: weekly for 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Rena R Wing, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716027
- Sponsor's protocol ID
- 2034-08
- Status last verified
- Jul 2008
- First submitted
- 15 Jul 2008
- Last updated
- 29 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Social Comparison Theory to Behavioral Weight Loss: Does Modifying Group Membership Improve Outcome?
- ClinicalTrials.gov ID
- NCT00716027
- Acronym / sponsor ID
- 2034-08
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Jul 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.
The purpose of this study is to determine whether a modified behavioral treatment for weight loss that includes one-on-one treatment for individuals struggling to lose weight is associated with more weight loss than a standard behavioral treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Standard behavioral treatment for weight lossA 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity. |
| 2 | Experimental | Behavioral: Modified behavioral treatment for weight lossA 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity. In this intervention, individuals not meeting weight loss goals will be given one-on-one treatment. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI between 27 and 45 kg/m2
Key exclusion criteria (4 listed)
- participating in a weight loss program or taking a weight loss medication
- currently pregnant, lactating, or less than 6-months post-partum or plan to become pregnant during the time of the intervention.
- report a heart condition, chest pain during periods of activity or rest, or loss of consciousness
- report conditions that would render the participant unlikely to follow the study protocol (e.g., terminal illness, relocation, substance abuse, sever psychiatric condition, dementia).
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 treatment for weight lossA 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity. | Behavioural | 1 |
| Modified behavioral treatment for weight lossA 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity. In this intervention, individuals not meeting weight loss goals will be given one-on-one treatment. | Behavioural | 2 |
Primary outcome
weight
Time frame: weekly for 24-weeks
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 29 Sep 2010.
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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.
Rena R Wing, PhD principal investigator
The Miriam Hospital
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 treatment for weight loss and Modified behavioral treatment for weight loss in people with Obesity, run by The Miriam Hospital 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 1 inclusion and 4 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 29 Sep 2010. 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 (time frame: weekly for 24-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2010.