ObesityPhase 3NCT02008474
SHARE Study 4: Financial Incentives for Weight Loss
A Phase 3 study testing Online weight loss + incentives for behavior 3 months, Online weight loss + incentives for weight loss at month 3 and Online weight loss + Incentives for behavior 12 months in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
The purpose of this study is to examine different types of monetary incentive paradigms for weight loss. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Online weight loss + incentives for behavior 3 months, Online weight loss + incentives for weight loss at month 3 and Online weight loss + Incentives for behavior 12 months
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2016
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI >=25kg/m2
- English speaking
- Age 18-70
Who cannot join
- Health problems that make weight loss or unsupervised exercise unsafe
- Current pregnancy or plan to become pregnant int he next 12 months
- Planned relocation
- Current participation in weight loss research study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miriam Hospital's Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies: Study 4
The purpose of this study is to examine different types of monetary incentive paradigms for weight loss.
- Conditions
- Obesity
- Being tested
- Online weight loss + incentives for behavior 3 months, Online weight loss + incentives for weight loss at month 3, Online weight loss + Incentives for behavior 12 months, Online weight loss + Incentives for weight loss 12 months
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online weight loss + incentives for behavior 3 monthsBehavioural
Participants will receive monetary incentives for submitting their behavior change information into a study website
Online weight loss + incentives for weight loss at month 3Behavioural
Participants will receive an incentive for meeting their weight loss goal at month 3.
Online weight loss + Incentives for behavior 12 monthsBehavioural
Participants will receive incentives for submitting behavior change information over the course of 12 months.
Online weight loss + Incentives for weight loss 12 monthsBehavioural
Participants will be receive monetary incentives for reaching their weight loss goal at months 3 and 12.
| Study group | Role | What they receive |
|---|---|---|
| Online weight loss + Incentives for behavior 3 months | Active comparator | Not described Receives: Behavioral: Online weight loss + incentives for behavior 3 months |
| Online weight loss + Incentives for weight loss 3 months | Active comparator | Not described Receives: Behavioral: Online weight loss + incentives for weight loss at month 3 |
| Online weight loss + Incentives for behavior 12 months | Active comparator | Not described Receives: Behavioral: Online weight loss + Incentives for behavior 12 months |
| Online weight loss + Incentives for weight loss 12 months | Active comparator | Not described Receives: Behavioral: Online weight loss + Incentives for weight loss 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change from initial assessment to the 3-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram
Measured: 0 to 3 months
Secondary outcomes (2)
weight change from the initial assessment to the 12 month assessment measured on a digital scale to the nearest 0.1-kilogram
Measured: 0 to 12 months
Weight change from the 3 month assessment to the 12 month assessment measured on a digital scale to the nearest 0.1-kilogram
Measured: 3 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJun 2016
- Study completionJun 2016
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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rena Wing, PhD, Principal investigator, The Miriam HospitalTricia M Leahey, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008474
- Sponsor's protocol ID
- 211699-14
- Status last verified
- Aug 2016
- First submitted
- 6 Dec 2013
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies: Study 4
- ClinicalTrials.gov ID
- NCT02008474
- Acronym / sponsor ID
- 211699-14
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Dec 2013 (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 examine different types of monetary incentive paradigms for weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Online weight loss + Incentives for behavior 3 months | Active comparator | Behavioral: Online weight loss + incentives for behavior 3 months |
| Online weight loss + Incentives for weight loss 3 months | Active comparator | Behavioral: Online weight loss + incentives for weight loss at month 3 |
| Online weight loss + Incentives for behavior 12 months | Active comparator | Behavioral: Online weight loss + Incentives for behavior 12 months |
| Online weight loss + Incentives for weight loss 12 months | Active comparator | Behavioral: Online weight loss + Incentives for weight loss 12 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI >=25kg/m2
- English speaking
- Age 18-70
Key exclusion criteria (4 listed)
- Health problems that make weight loss or unsupervised exercise unsafe
- Current pregnancy or plan to become pregnant int he next 12 months
- Planned relocation
- Current participation in weight loss research study
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 |
|---|---|---|
| Online weight loss + incentives for behavior 3 monthsParticipants will receive monetary incentives for submitting their behavior change information into a study website | Behavioural | Online weight loss + Incentives for behavior 3 months |
| Online weight loss + incentives for weight loss at month 3Participants will receive an incentive for meeting their weight loss goal at month 3. | Behavioural | Online weight loss + Incentives for weight loss 3 months |
| Online weight loss + Incentives for behavior 12 monthsParticipants will receive incentives for submitting behavior change information over the course of 12 months. | Behavioural | Online weight loss + Incentives for behavior 12 months |
| Online weight loss + Incentives for weight loss 12 monthsParticipants will be receive monetary incentives for reaching their weight loss goal at months 3 and 12. | Behavioural | Online weight loss + Incentives for weight loss 12 months |
Primary outcome
weight change from initial assessment to the 3-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram
Time frame: 0 to 3 months
2 secondary outcomes
weight change from the initial assessment to the 12 month assessment measured on a digital scale to the nearest 0.1-kilogram
Time frame: 0 to 12 months
Weight change from the 3 month assessment to the 12 month assessment measured on a digital scale to the nearest 0.1-kilogram
Time frame: 3 to 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 30 Aug 2016.
Related trials for Obesity
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
Obesity
Recruiting
Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort
Joint Osteoarthritis, Atherosclerosis of the Distal Arteries, Without Gangrene
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Active, not recruiting
Eat, Move, Live Program for the Reduction of Cancer and Chronic Disease Risk in Underserved Communities
Diabetes Mellitus, Obesity-Related Malignant Neoplasm
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.
Rena Wing, PhD principal investigator
The Miriam Hospital
Tricia M Leahey, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Online weight loss + incentives for behavior 3 months, Online weight loss + incentives for weight loss at month 3 and Online weight loss + Incentives for behavior 12 months in people with Obesity, run by The Miriam Hospital 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 4 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 30 Aug 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
weight change from initial assessment to the 3-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram (time frame: 0 to 3 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 30 Aug 2016; AzTrials last refreshed its copy on 5 Nov 2026.