ObesityPhase 3SHARENCT01560130
State-wide Health Approach to Increase Reach and Effectiveness: Study 2
A Phase 3 study testing Shape Up Rhode Island + Online weight loss program, Shape Up Rhode Island + Online weight loss program + Groups and Shape Up Rhode Island + Online weight loss + Incentives in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
Behavioral weight loss programs can successfully reduce body weight, but these programs are available to limited numbers of overweight and obese individuals. This project evaluates a unique weight loss approach that combines a self-sustaining weight loss campaign (for outreach) with training in behavioral weight loss… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Shape Up Rhode Island + Online weight loss program, Shape Up Rhode Island + Online weight loss program + Groups and Shape Up Rhode Island + Online weight loss + Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Feb 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index >=25 kg/m2
- English speaking
Who cannot join
- Health problems that make weight loss or unsupervised exercise unsafe
- Current pregnancy or plan to become pregnant in the next 12 months
- Planned relocation
- Previous participation in Shape Up Rhode Island research studies
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
Behavioral weight loss programs can successfully reduce body weight, but these programs are available to limited numbers of overweight and obese individuals. This project evaluates a unique weight loss approach that combines a self-sustaining weight loss campaign (for outreach) with training in behavioral weight loss strategies and tests the efficacy of adding components designed to enhance accountability and increase motivation for weight loss.
Read the detailed description
This is a randomized trial. Participants will be randomly assigned to 1 of 3 treatment arms: (1) Shape Up Rhode Island (a community-based weight loss campaign) plus and Internet-based behavioral weight loss program (SURI+IBWL), (2) SURI + IBWL + optional group sessions (SURI+IBWL+Group), or (3) SURI+IBWL + monetary incentives for submitting self-monitoring information and achieving clinically significant weight loss. The primary outcome is weight loss at 12 weeks.
- Conditions
- Obesity
- Being tested
- Shape Up Rhode Island + Online weight loss program, Shape Up Rhode Island + Online weight loss program + Groups, Shape Up Rhode Island + Online weight loss + Incentives
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shape Up Rhode Island + Online weight loss programBehavioural
Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention and an Internet-based behavioral weight loss program.
Shape Up Rhode Island + Online weight loss program + GroupsBehavioural
Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention, an Internet-based behavioral weight loss program, and the option to attend group sessions.
Shape Up Rhode Island + Online weight loss + IncentivesBehavioural
Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention, an Internet-based behavioral weight loss program, and monetary incentives for submitting self-monitoring information and for achieving clinically significant weight loss.
| Study group | Role | What they receive |
|---|---|---|
| Shape Up Rhode Island + Online Weight Loss + Incentives | Active comparator | Not described Receives: Behavioral: Shape Up Rhode Island + Online weight loss + Incentives |
| Shape Up Rhode Island + Online weight loss program | Active comparator | Not described Receives: Behavioral: Shape Up Rhode Island + Online weight loss program |
| Shape Up Rhode Island + Online weight loss program + groups | Active comparator | Not described Receives: Behavioral: Shape Up Rhode Island + Online weight loss program + Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change from the 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 6-month assessment measured on a digital scale to the nearest 0.1-kilogram
Measured: 0 to 6 months
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rena R. Wing, The Miriam Hospital
- Investigators
- Rena R Wing, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560130
- Sponsor's protocol ID
- 211699-7
- Other IDs
- R18DK083248
- Acronym
- SHARE
- Status last verified
- Apr 2013
- First submitted
- 20 Mar 2012
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. 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
- ClinicalTrials.gov ID
- NCT01560130
- Acronym / sponsor ID
- SHARE / 211699-7
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 Mar 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.
Behavioral weight loss programs can successfully reduce body weight, but these programs are available to limited numbers of overweight and obese individuals. This project evaluates a unique weight loss approach that combines a self-sustaining weight loss campaign (for outreach) with training in behavioral weight loss strategies and tests the efficacy of adding components designed to enhance accountability and increase motivation for weight loss.
Detailed description
This is a randomized trial. Participants will be randomly assigned to 1 of 3 treatment arms: (1) Shape Up Rhode Island (a community-based weight loss campaign) plus and Internet-based behavioral weight loss program (SURI+IBWL), (2) SURI + IBWL + optional group sessions (SURI+IBWL+Group), or (3) SURI+IBWL + monetary incentives for submitting self-monitoring information and achieving clinically significant weight loss. The primary outcome is weight loss at 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shape Up Rhode Island + Online Weight Loss + Incentives | Active comparator | Behavioral: Shape Up Rhode Island + Online weight loss + Incentives |
| Shape Up Rhode Island + Online weight loss program | Active comparator | Behavioral: Shape Up Rhode Island + Online weight loss program |
| Shape Up Rhode Island + Online weight loss program + groups | Active comparator | Behavioral: Shape Up Rhode Island + Online weight loss program + Groups |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index >=25 kg/m2
- English speaking
Key exclusion criteria (4 listed)
- Health problems that make weight loss or unsupervised exercise unsafe
- Current pregnancy or plan to become pregnant in the next 12 months
- Planned relocation
- Previous participation in Shape Up Rhode Island research studies
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 |
|---|---|---|
| Shape Up Rhode Island + Online weight loss programParticipants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention and an Internet-based behavioral weight loss program. | Behavioural | Shape Up Rhode Island + Online weight loss program |
| Shape Up Rhode Island + Online weight loss program + GroupsParticipants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention, an Internet-based behavioral weight loss program, and the option to attend group sessions. | Behavioural | Shape Up Rhode Island + Online weight loss program + groups |
| Shape Up Rhode Island + Online weight loss + IncentivesParticipants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention, an Internet-based behavioral weight loss program, and monetary incentives for submitting self-monitoring information and for achieving clinically significant weight loss. | Behavioural | Shape Up Rhode Island + Online Weight Loss + Incentives |
Primary outcome
Weight change from the 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 6-month assessment measured on a digital scale to the nearest 0.1-kilogram
Time frame: 0 to 6 months
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
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 24 Apr 2013.
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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.
Rena R Wing, 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 Shape Up Rhode Island + Online weight loss program, Shape Up Rhode Island + Online weight loss program + Groups and Shape Up Rhode Island + Online weight loss + Incentives 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 2 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 24 Apr 2013. 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 the 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 24 Apr 2013.