ObesityEarly Phase 1ObesityNCT01629576
Obesity and Financial Incentives
A Early Phase 1 study testing economic incentive in people with Obesity, run by Rhine-Westphalia Institute for Economic Research at 1 site in Germany.
Trial summary
Investigate whether economic incentives help obese individuals to lose weight. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- economic incentive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Oct 2014
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI above 30
- age between 18 anf 75
- registered residence in the German federal state of Baden-Württemberg
Who cannot join
- considerable language barriers
- pregnancy
- psychological disorders
- eating disorders
- tumor disease within last five years
- abuse of alcohol
- abuse of drugs
- serious general diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Finanzielle Anreize Zur Reduktion Von Übergewicht
Investigate whether economic incentives help obese individuals to lose weight.
- Conditions
- Obesity
- Being tested
- economic incentive
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
economic incentiveOther
economic incentive for weight loss
economic incentiveOther
economic incentive for weight loss
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| low reward | Experimental | economic incentive Receives: Other: economic incentive |
| high reward | Experimental | economic incentive Receives: Other: economic incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
bodyweight
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startMar 2010
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhine-Westphalia Institute for Economic Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629576
- Sponsor's protocol ID
- 010902
- Acronym
- Obesity
- Status last verified
- Jun 2012
- First submitted
- 21 Jun 2012
- Last updated
- 27 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finanzielle Anreize Zur Reduktion Von Übergewicht
- ClinicalTrials.gov ID
- NCT01629576
- Acronym / sponsor ID
- Obesity / 010902
- Conditions
- Obesity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Rhine-Westphalia Institute for Economic ResearchUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 27 Jun 2012 (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.
Investigate whether economic incentives help obese individuals to lose weight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| low reward | Experimental | Other: economic incentiveeconomic incentive |
| high reward | Experimental | Other: economic incentiveeconomic incentive |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI above 30
- age between 18 anf 75
- registered residence in the German federal state of Baden-Württemberg
Key exclusion criteria (8 listed)
- considerable language barriers
- pregnancy
- psychological disorders
- eating disorders
- tumor disease within last five years
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 |
|---|---|---|
| economic incentiveeconomic incentive for weight loss | Other | low reward |
| economic incentiveeconomic incentive for weight loss | Other | high reward |
Primary outcome
bodyweight
Time frame: 22 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
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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 Early Phase 1 study testing economic incentive in people with Obesity, run by Rhine-Westphalia Institute for Economic Research at 1 site in Germany.
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 8 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: status not confirmed, as of the sponsor's last update on 27 Jun 2012. 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 Germany. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
bodyweight (time frame: 22 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 27 Jun 2012.