OverweightPhase 2NCT00875199
Contingency Management to Promote Weight Loss in Low Income Adults
A Phase 2 study testing contingency management and weight loss manual-guided individual therapy sessions in people with Overweight, run by UConn Health at 1 site in United States.
Trial summary
This study is designed to evaluate the feasibility and provide preliminary evidence for efficacy of a 12-week contingency management intervention to promote weight loss in overweight and obese low income adults in a community-based clinic. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Overweight
- What is being tested?
- contingency management and weight loss manual-guided individual therapy sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Mar 2010
- Phase
- Phase 2
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 18 and 55 years
- body mass index in kg/m2 (BMI) between 25 and 39.9
- resting blood pressure between 90/60 and 140/90
- ability to speak English and read at the 6th grade level
- willingness to be randomly assigned to one of two groups
Who cannot join
- any serious acute or chronic medical problems that may impact dietary or exercise regimens
- psychiatric conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
This study is designed to evaluate the feasibility and provide preliminary evidence for efficacy of a 12-week contingency management intervention to promote weight loss in overweight and obese low income adults in a community-based clinic. The study has three primary goals: (a) to determine if the contingency management treatment can be effectively applied to a new application, weight loss; (b) to obtain preliminary evidence for contingency management's efficacy in promoting weight loss and improving treatment retention, diet quality, physical activity levels, and self efficacy; and (c) to identify barriers and challenges to implementing contingency management for weight loss among low income patients.
- Conditions
- Overweight
- Being tested
- contingency management, weight loss manual-guided individual therapy sessions
- Keywords
- Overweight, Obesity, Contingency Management
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contingency managementBehavioural
Prize-based contingency management for weight loss
weight loss manual-guided individual therapy sessionsBehavioural
once weekly counseling session with research staff
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Participants assigned to Group A will receive the DPP manual (Wing \& Gillis, 1996), a behavioral weight-loss program with demonstrated efficacy in facilitating weight loss. Participants in Group A will be instructed to read a section of the manual each week and complete suggested activities. They will also meet with the research staff once a week for weigh-in and supportive counseling. Receives: Behavioral: weight loss manual-guided individual therapy sessions |
| B | Experimental | Participants assigned to Group B will receive the DPP manual and will meet with research staff each week for weigh-in and supportive counseling. They will also receive contingency management or the opportunity to earn draws with the chance of winning prizes for losing weight and completing healthy activities. Receives: Behavioral: contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute and relative weight loss
Measured: pre-treatment, weekly during active phase, post-treatment
number of participants achieving clinically significant weight loss (5% or more of baseline weight)
Measured: pre-treatment, weekly during active phase, post-treatment
Secondary outcomes (3)
retention
Measured: during active phase
changes on measures of diet quality, physical activity, and self-efficacy
Measured: pre-treatment, post-treatment
self-reports, focus groups
Measured: pre-treatment, post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle M Barry, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875199
- Sponsor's protocol ID
- 09-108-2
- Other IDs
- 20090009
- Status last verified
- Nov 2011
- First submitted
- 31 Mar 2009
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management to Promote Weight Loss in Low Income Adults
- ClinicalTrials.gov ID
- NCT00875199
- Acronym / sponsor ID
- 09-108-2
- Conditions
- Overweight
- Keywords
- Overweight, Obesity, Contingency Management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 3 Apr 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.
This study is designed to evaluate the feasibility and provide preliminary evidence for efficacy of a 12-week contingency management intervention to promote weight loss in overweight and obese low income adults in a community-based clinic. The study has three primary goals: (a) to determine if the contingency management treatment can be effectively applied to a new application, weight loss; (b) to obtain preliminary evidence for contingency management's efficacy in promoting weight loss and improving treatment retention, diet quality, physical activity levels, and self efficacy; and (c) to identify barriers and challenges to implementing contingency management for weight loss among low income patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Behavioral: weight loss manual-guided individual therapy sessionsParticipants assigned to Group A will receive the DPP manual (Wing \& Gillis, 1996), a behavioral weight-loss program with demonstrated efficacy in facilitating weight loss. Participants in Group A will be instructed to read a section of the manual each week and complete suggested activities. They will also meet with the research staff once a week for weigh-in and supportive counseling. |
| B | Experimental | Behavioral: contingency managementParticipants assigned to Group B will receive the DPP manual and will meet with research staff each week for weigh-in and supportive counseling. They will also receive contingency management or the opportunity to earn draws with the chance of winning prizes for losing weight and completing healthy activities. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age between 18 and 55 years
- body mass index in kg/m2 (BMI) between 25 and 39.9
- resting blood pressure between 90/60 and 140/90
- ability to speak English and read at the 6th grade level
- willingness to be randomly assigned to one of two groups
Key exclusion criteria (2 listed)
- any serious acute or chronic medical problems that may impact dietary or exercise regimens
- psychiatric conditions
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 |
|---|---|---|
| contingency managementPrize-based contingency management for weight loss | Behavioural | B |
| weight loss manual-guided individual therapy sessionsonce weekly counseling session with research staff | Behavioural | A |
Primary outcome
absolute and relative weight loss
Time frame: pre-treatment, weekly during active phase, post-treatment
number of participants achieving clinically significant weight loss (5% or more of baseline weight)
Time frame: pre-treatment, weekly during active phase, post-treatment
3 secondary outcomes
retention
Time frame: during active phase
changes on measures of diet quality, physical activity, and self-efficacy
Time frame: pre-treatment, post-treatment
self-reports, focus groups
Time frame: pre-treatment, post-treatment
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 21 Nov 2011.
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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.
Danielle M Barry, Ph.D. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing contingency management and weight loss manual-guided individual therapy sessions in people with Overweight, run by UConn Health 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 5 inclusion and 2 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 21 Nov 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
absolute and relative weight loss (time frame: pre-treatment, weekly during active phase, post-treatment). The study lists 2 primary outcomes in all. 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 21 Nov 2011.