ObesityPhase 3SHARENCT01264393
State-wide Health Approach to Increase Reach and Effectiveness: Study 1
A Phase 3 study testing Shape Up Rhode Island + Online Resources, Shape Up Rhode Island + Online Weight Loss Program and Shape Up Rhode Island + Online Weight Loss Program + Group sessions 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 years
- Conditions the study is for
- Obesity
- What is being tested?
- Shape Up Rhode Island + Online Resources, Shape Up Rhode Island + Online Weight Loss Program and Shape Up Rhode Island + Online Weight Loss Program + Group sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-70 years
- Body Mass Index >25 kg/m2
- Both genders will be recruited; it is estimated that 70% of participants will be women.
- All ethnic groups will be recruited, with a goal of recruiting 33% minorities (see below for specific recruitment plans)
- No health problems that make weight loss or unsupervised exercise unsafe
- English speaking
Who cannot join
- report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4). Individuals endorsing joint problems, prescription medication use or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
- are currently pregnant or intend to become pregnant in the next 12 months
- are planning to move outside of the state within the next 12 months
- have previously participated in the Shape Up Rhode Island 2008 pilot 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
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 strategies to increase accountability (to improve weight loss success). This innovative combination has the potential to be a cost-effective model for disseminating weight control interventions.
Read the detailed description
Participants will be randomly assigned to 1 of 3 treatment arms: Shape Up Rhode Island (SURI; a community-based weight loss campaign), SURI plus an Internet-based behavioral weight loss program (SURI + IBWL), or SURI + IBWL + optional group sessions (SURI + IBWL + Group). Primary outcome is weight loss at 12-weeks.
- Conditions
- Obesity
- Being tested
- Shape Up Rhode Island + Online Resources, Shape Up Rhode Island + Online Weight Loss Program, Shape Up Rhode Island + Online Weight Loss Program + Group sessions
- 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 ResourcesBehavioural
Participants will receive Shape Up Rhode Island, which is a 12-week statewide physical activity and weight loss campaign in addition to online weight loss resources
Shape Up Rhode Island + Online Weight Loss ProgramBehavioural
Participants will receive Shape Up Rhode Island, a 12-week statewide physical activity and weight loss campaign in addition to an online weight loss program
Shape Up Rhode Island + Online Weight Loss Program + Group sessionsBehavioural
Participants will receive Shape Up Rhode Island, a 12-week statewide physical activity and weight loss campaign in addition to an online weight loss program and the option of attending group sessions
| Study group | Role | What they receive |
|---|---|---|
| Shape Up Rhode Island + Online weight loss program + groups | Active comparator | Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention, an internet-based weight loss program, and the option of attending face-to-face group sessions Receives: Behavioral: Shape Up Rhode Island + Online Weight Loss Program + Group sessions |
| Shape Up Rhode Island + Online Weight Loss Program | Active comparator | Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention in addition to an internet-based weight loss program Receives: Behavioral: Shape Up Rhode Island + Online Weight Loss Program |
| Shape Up Rhode Island + Internet Resources | Active comparator | Participants in this arm will receive the Standard Shape Up Rhode Island statewide intervention plus access to internet resources Receives: Behavioral: Shape Up Rhode Island + Online Resources |
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 follow-up 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 follow-up 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 posted21 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 500 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
- NCT01264393
- Sponsor's protocol ID
- 2054-10
- Other IDs
- R18DK083248
- Acronym
- SHARE
- Status last verified
- Apr 2013
- First submitted
- 17 Dec 2010
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wing RR, Crane MM, Thomas JG, Kumar R, Weinberg B. Improving weight loss outcomes of community interventions by incorporating behavioral strategies. Am J Public Health. 2010 Dec;100(12):2513-9. doi: 10.2105/AJPH.2009.183616. Epub 2010 Oct 21.
PubMed 20966375Naparstek J, Wing RR, Xu X, Leahey TM. Internet-delivered obesity treatment improves symptoms of and risk for depression. Obesity (Silver Spring). 2017 Apr;25(4):671-675. doi: 10.1002/oby.21773. Epub 2017 Feb 22.
PubMed 28224713
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
- NCT01264393
- Acronym / sponsor ID
- SHARE / 2054-10
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Dec 2010 (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 strategies to increase accountability (to improve weight loss success). This innovative combination has the potential to be a cost-effective model for disseminating weight control interventions.
Detailed description
Participants will be randomly assigned to 1 of 3 treatment arms: Shape Up Rhode Island (SURI; a community-based weight loss campaign), SURI plus an Internet-based behavioral weight loss program (SURI + IBWL), or SURI + IBWL + optional group sessions (SURI + IBWL + Group). 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 program + groups | Active comparator | Behavioral: Shape Up Rhode Island + Online Weight Loss Program + Group sessionsParticipants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention, an internet-based weight loss program, and the option of attending face-to-face group sessions |
| Shape Up Rhode Island + Online Weight Loss Program | Active comparator | Behavioral: Shape Up Rhode Island + Online Weight Loss ProgramParticipants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention in addition to an internet-based weight loss program |
| Shape Up Rhode Island + Internet Resources | Active comparator | Behavioral: Shape Up Rhode Island + Online ResourcesParticipants in this arm will receive the Standard Shape Up Rhode Island statewide intervention plus access to internet resources |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18-70 years
- Body Mass Index >25 kg/m2
- Both genders will be recruited; it is estimated that 70% of participants will be women.
- All ethnic groups will be recruited, with a goal of recruiting 33% minorities (see below for specific recruitment plans)
- No health problems that make weight loss or unsupervised exercise unsafe
Key exclusion criteria (4 listed)
- report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4). Individuals endorsing joint problems, prescription medication use or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
- are currently pregnant or intend to become pregnant in the next 12 months
- are planning to move outside of the state within the next 12 months
- have previously participated in the Shape Up Rhode Island 2008 pilot 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 |
|---|---|---|
| Shape Up Rhode Island + Online ResourcesParticipants will receive Shape Up Rhode Island, which is a 12-week statewide physical activity and weight loss campaign in addition to online weight loss resources | Behavioural | Shape Up Rhode Island + Internet Resources |
| Shape Up Rhode Island + Online Weight Loss ProgramParticipants will receive Shape Up Rhode Island, a 12-week statewide physical activity and weight loss campaign in addition to an online weight loss program | Behavioural | Shape Up Rhode Island + Online Weight Loss Program |
| Shape Up Rhode Island + Online Weight Loss Program + Group sessionsParticipants will receive Shape Up Rhode Island, a 12-week statewide physical activity and weight loss campaign in addition to an online weight loss program and the option of attending group sessions | Behavioural | Shape Up Rhode Island + Online weight loss program + groups |
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 follow-up 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 follow-up 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.
- Background: PubMed 20966375Wing RR, Crane MM, Thomas JG, Kumar R, Weinberg B. Improving weight loss outcomes of community interventions by incorporating behavioral strategies. Am J Public Health. 2010 Dec;100(12):2513-9. doi: 10.2105/AJPH.2009.183616. Epub 2010 Oct 21.
- Derived from this study: PubMed 28224713Naparstek J, Wing RR, Xu X, Leahey TM. Internet-delivered obesity treatment improves symptoms of and risk for depression. Obesity (Silver Spring). 2017 Apr;25(4):671-675. doi: 10.1002/oby.21773. Epub 2017 Feb 22.
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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 Resources, Shape Up Rhode Island + Online Weight Loss Program and Shape Up Rhode Island + Online Weight Loss Program + Group sessions 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 6 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?
On the ClinicalTrials.gov record for NCT01264393, which also lists 2 linked publications.
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.