ObesityNCT02088749
Comparison of Weight Management Programs Delivered in Large Versus Small Groups
A study testing lifestyle intervention for obesity in people with Obesity, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
The purpose of this study is to compare the 6- and 12-month weight changes associated with lifestyle interventions delivered in a large group or small groups of participants. It is hypothesized that participants receiving treatment in a small group will have greater weight loss than those assigned to a larger group. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- lifestyle intervention for obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to Dec 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 21 years-old
- body mass index (BMI) between 30-45
Who cannot join
- have lost >4.5 kg in past six months
- have medical condition(s) likely to affect ability to participate in physical activity
- planning to relocate from the area in next 12 months
- unable or unwilling to attend weekly group sessions
- unwilling to accept random assignment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Florida State University
Tallahassee, Florida, 32309
About this study
The purpose of this study is to compare the 6- and 12-month weight changes associated with lifestyle interventions delivered in a large group or small groups of participants. It is hypothesized that participants receiving treatment in a small group will have greater weight loss than those assigned to a larger group.
- Conditions
- Obesity
- Being tested
- lifestyle intervention for obesity
- Keywords
- obesity, weight loss, treatment, lifestyle
- 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.
lifestyle intervention for obesityBehavioural
| Study group | Role | What they receive |
|---|---|---|
| small group treatment | Experimental | lifestyle intervention for obesity delivered to small groups of approximately 12 participants/group Receives: Behavioral: lifestyle intervention for obesity |
| large group treatment | Active comparator | lifestyle intervention for obesity delivered to a large group of approximately 30 participants Receives: Behavioral: lifestyle intervention for obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in body weight from baseline to months 6 and 12
Weight will be measured to the nearest 0.1 kg using calibrated digital scales at baseline, month 6, and month 12.
Measured: baseline, month 6, month 12
Secondary outcomes (2)
treatment attendance
Participants attendance at each treatment group session was recorded.
Measured: 12 months
treatment adherence
Participants' self-monitoring of food intake was collected to determine adherence to this component of treatment.
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 posted17 Mar 2014 (estimated)
- Study startMay 2010
- Primary completionSep 2011
- Study completionDec 2011
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 University of Alabama at BirminghamThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gareth R. Dutton PhD, University of Alabama at Birmingham
- Investigators
- Gareth Dutton, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088749
- Sponsor's protocol ID
- K23DK081607-pilot
- Other IDs
- K23DK081607
- Status last verified
- Jan 2024
- First submitted
- 12 Mar 2014
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Weight Management Programs Delivered in Large Versus Small Groups
- ClinicalTrials.gov ID
- NCT02088749
- Acronym / sponsor ID
- K23DK081607-pilot
- Conditions
- Obesity
- Keywords
- obesity, weight loss, treatment, lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Mar 2014 (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 compare the 6- and 12-month weight changes associated with lifestyle interventions delivered in a large group or small groups of participants. It is hypothesized that participants receiving treatment in a small group will have greater weight loss than those assigned to a larger 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 treatment | Experimental | Behavioral: lifestyle intervention for obesitylifestyle intervention for obesity delivered to small groups of approximately 12 participants/group |
| large group treatment | Active comparator | Behavioral: lifestyle intervention for obesitylifestyle intervention for obesity delivered to a large group of approximately 30 participants |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 21 years-old
- body mass index (BMI) between 30-45
Key exclusion criteria (5 listed)
- have lost >4.5 kg in past six months
- have medical condition(s) likely to affect ability to participate in physical activity
- planning to relocate from the area in next 12 months
- unable or unwilling to attend weekly group sessions
- 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 |
|---|---|---|
| lifestyle intervention for obesity | Behavioural | large group treatment, small group treatment |
Primary outcome
change in body weight from baseline to months 6 and 12
Time frame: baseline, month 6, month 12
Weight will be measured to the nearest 0.1 kg using calibrated digital scales at baseline, month 6, and month 12.
2 secondary outcomes
treatment attendance
Time frame: 12 months
treatment adherence
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 11 Jan 2024.
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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.
Gareth Dutton, PhD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle intervention for obesity in people with Obesity, run by University of Alabama at Birmingham at 2 sites 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 2 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: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
change in body weight from baseline to months 6 and 12 (time frame: baseline, month 6, month 12). 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 11 Jan 2024.