ObesityNCT00250510
Reimbursement Effects on Enrollment in Obesity Treatment
A study testing Simulated insurance reimbursement in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The purpose of this study is to simulate what would occur if insurance reimbursement became available for obesity treatment but required that the individual meet defined performance milestones. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Simulated insurance reimbursement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Dec 2006
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with obesity (BMI at least 30 kg/m2)
- Commitment of the full EatRight Weight Management Program fee
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3360
About this study
Official title: A Prospective Study to Determine the Effects of a Reimbursement Incentive on Enrollment and Outcomes in a Community Weight Control Program.
The purpose of this study is to simulate what would occur if insurance reimbursement became available for obesity treatment but required that the individual meet defined performance milestones.
Read the detailed description
This is a prospective study to determine whether a reimbursement incentive (the prospect of reimbursement of half of the out-of-pocket fee for participation in the UAB EatRight Weight Management Program, when it is contingent upon consistent Program participation and loss of 6% of initial body weight) is associated with (1) a higher rate of Program enrollment and (2) greater percent weight loss, greater reductions in medication dosages and costs, and fewer visits to health care providers after 12 weeks and 9 months.
- Conditions
- Obesity
- Being tested
- Simulated insurance reimbursement
- Keywords
- Obesity treatment, Insurance reimbursement, Health care utilization, Health care costs
- Medical subject headings
- Obesity, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated insurance reimbursementBehavioural
Participants were told they would have the possibility of being reimbursed 50% ($150) of their initial fee ($300) if they: 1) paid the fee in advance or committed 3 monthly payments in advance, 2) attended 10 of 12 class sessions, and 3) lost at least 6% of their current body weight during the program.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Experimental | EatRight Program inquirers with BMI's of 30 kg/m2 or greater were told that they would have the possibility of being reimbursed 50% ($150) of their initial fee ($300) if certain conditions were met. Receives: Behavioral: Simulated insurance reimbursement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of inquirers who enroll in obesity treatment
Measured: 16 months
Secondary outcomes (4)
Class attendance
Measured: 12 weeks
Percent weight loss
Measured: 12 weeks and 9 months
Changes in medication dosages and costs
Measured: 12 weeks and 9 months
Visits to health care providers
Measured: 12 weeks and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startJun 2004
- Study completionDec 2006
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.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Douglas C Heimburger, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250510
- Sponsor's protocol ID
- R03 DK67357 (completed)
- Other IDs
- R03DK067357
- Status last verified
- Mar 2010
- First submitted
- 7 Nov 2005
- Last updated
- 18 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hubbert KA, Bussey BF, Allison DB, Beasley TM, Henson CS, Heimburger DC. Effects of outcome-driven insurance reimbursement on short-term weight control. Int J Obes Relat Metab Disord. 2003 Nov;27(11):1423-9. doi: 10.1038/sj.ijo.0802403.
PubMed 14574356
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Determine the Effects of a Reimbursement Incentive on Enrollment and Outcomes in a Community Weight Control Program.
- ClinicalTrials.gov ID
- NCT00250510
- Acronym / sponsor ID
- R03 DK67357 (completed)
- Conditions
- Obesity
- Keywords
- Obesity treatment, Insurance reimbursement, Health care utilization, Health care costs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Jun 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 8 Nov 2005 (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 simulate what would occur if insurance reimbursement became available for obesity treatment but required that the individual meet defined performance milestones.
Detailed description
This is a prospective study to determine whether a reimbursement incentive (the prospect of reimbursement of half of the out-of-pocket fee for participation in the UAB EatRight Weight Management Program, when it is contingent upon consistent Program participation and loss of 6% of initial body weight) is associated with (1) a higher rate of Program enrollment and (2) greater percent weight loss, greater reductions in medication dosages and costs, and fewer visits to health care providers after 12 weeks and 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Experimental | Behavioral: Simulated insurance reimbursementEatRight Program inquirers with BMI's of 30 kg/m2 or greater were told that they would have the possibility of being reimbursed 50% ($150) of their initial fee ($300) if certain conditions were met. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with obesity (BMI at least 30 kg/m2)
- Commitment of the full EatRight Weight Management Program fee
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Simulated insurance reimbursementParticipants were told they would have the possibility of being reimbursed 50% ($150) of their initial fee ($300) if they: 1) paid the fee in advance or committed 3 monthly payments in advance, 2) attended 10 of 12 class sessions, and 3) lost at least 6% of their current body weight during the program. | Behavioural | 2 |
Primary outcome
Proportion of inquirers who enroll in obesity treatment
Time frame: 16 months
4 secondary outcomes
Class attendance
Time frame: 12 weeks
Percent weight loss
Time frame: 12 weeks and 9 months
Changes in medication dosages and costs
Time frame: 12 weeks and 9 months
Visits to health care providers
Time frame: 12 weeks and 9 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 18 Mar 2010.
- Background: PubMed 14574356Hubbert KA, Bussey BF, Allison DB, Beasley TM, Henson CS, Heimburger DC. Effects of outcome-driven insurance reimbursement on short-term weight control. Int J Obes Relat Metab Disord. 2003 Nov;27(11):1423-9. doi: 10.1038/sj.ijo.0802403.
- UAB EatRight Weight Management ProgramLink provided by the sponsor.
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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.
Douglas C Heimburger, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated insurance reimbursement in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 2 inclusion and 1 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 18 Mar 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?
Proportion of inquirers who enroll in obesity treatment (time frame: 16 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 NCT00250510, 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 18 Mar 2010.