ObesityPhase 4NCT01165151
Impact of Group Size in Weight Loss Interventions
A Phase 4 study testing behavioral weight loss program in people with Obesity and Weight Loss, run by Florida State University at 1 site in United States.
Trial summary
The present study will assess whether the size of treatment groups (groups of 10 vs. 30 participants) affects short- and long-term weight loss. It is hypothesized that participants assigned to a small group will exhibit similar short-term and long-term weight losses (i.e., weight loss at months 6 and 12) as compared… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- behavioral weight loss program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2014
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (at least 21 years-old)
- Health insurance coverage with Capital Health Plan (CHP)
- Body mass index BMI between 30-45 kg/m2
Who cannot join
- BMI is less than 30 kg/m2 or greater than 45 kg/m2
- Weight loss > 10 pounds in past 6 months
- Acute or chronic illnesses for which weight loss is contraindicated
- Unwilling or unable to give informed consent
- Unwilling to accept random assignment
- Unwilling or unable to travel to CHP clinic for assessments and groups
- Likely to relocate out of the area in the next 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Improving Weight Loss Maintenance Through Alternatives Schedules of Treatment
The present study will assess whether the size of treatment groups (groups of 10 vs. 30 participants) affects short- and long-term weight loss. It is hypothesized that participants assigned to a small group will exhibit similar short-term and long-term weight losses (i.e., weight loss at months 6 and 12) as compared to those assigned to a large group.
- Conditions
- Obesity, Weight Loss
- Being tested
- behavioral weight loss program
- Keywords
- obesity, weight loss, group size
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral weight loss programBehavioural
weekly, group-based lifestyle weight loss program
| Study group | Role | What they receive |
|---|---|---|
| Small group | Experimental | 10-member groups Receives: Behavioral: behavioral weight loss program |
| Large group | Active comparator | 30-member groups Receives: Behavioral: behavioral weight loss program |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in weight from baseline to month 12
Measured: 12 months
Secondary outcomes (1)
adherence to treatment protocol
number and proportion of treatment sessions attended
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 posted19 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2014
- Study completionDec 2014
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.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165151
- Sponsor's protocol ID
- DK081607-01A1
- Status last verified
- Mar 2015
- First submitted
- 16 Jul 2010
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Weight Loss Maintenance Through Alternatives Schedules of Treatment
- ClinicalTrials.gov ID
- NCT01165151
- Acronym / sponsor ID
- DK081607-01A1
- Conditions
- Obesity, Weight Loss
- Keywords
- obesity, weight loss, group size
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Jul 2010 (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 present study will assess whether the size of treatment groups (groups of 10 vs. 30 participants) affects short- and long-term weight loss. It is hypothesized that participants assigned to a small group will exhibit similar short-term and long-term weight losses (i.e., weight loss at months 6 and 12) as compared to those assigned to a large group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small group | Experimental | Behavioral: behavioral weight loss program10-member groups |
| Large group | Active comparator | Behavioral: behavioral weight loss program30-member groups |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (at least 21 years-old)
- Health insurance coverage with Capital Health Plan (CHP)
- Body mass index BMI between 30-45 kg/m2
Key exclusion criteria (7 listed)
- BMI is less than 30 kg/m2 or greater than 45 kg/m2
- Weight loss > 10 pounds in past 6 months
- Acute or chronic illnesses for which weight loss is contraindicated
- Unwilling or unable to give informed consent
- Unwilling to accept random assignment
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 |
|---|---|---|
| behavioral weight loss programweekly, group-based lifestyle weight loss program | Behavioural | Large group, Small group |
Primary outcome
change in weight from baseline to month 12
Time frame: 12 months
1 secondary outcome
adherence to treatment protocol
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 6 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing behavioral weight loss program in people with Obesity and Weight Loss, run by Florida State University 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 7 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 6 Mar 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change in weight from baseline to month 12 (time frame: 12 months). 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 6 Mar 2015.