Weight LossSTOPRegainNCT00466141
Weight Maintenance Study for 2007 Shape UP RI Participants
A study testing Increased Exercise for weight loss maintenance, Daily Self-weighing for weight loss maintenance and Education for weight loss maintenance in people with Weight Loss, run by The Miriam Hospital at 1 site in United States.
Trial summary
This study will focus on maintenance of weight loss achieved in the 2007 Shape-Up Rhode Island(SURI)program. We plan to recruit 180 individuals who participated in SURI and lost at least 10 pounds to take part in a 4-month weight loss maintenance program when the SURI ends. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Increased Exercise for weight loss maintenance, Daily Self-weighing for weight loss maintenance and Education for weight loss maintenance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Oct 2007
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are 18 years or older
- Lost 10 or more pounds during the 2007 Shape Up RI program
- Want to learn skills to maintain your weight loss
- Can come to the Weight Control and Diabetes Research Center located at 196 Richmond Street in the "The Jewelry District" of Providence for a baseline assessment visit in mid-May/mid-June and final assessment visit in mid-October.
- Agree to be randomly assigned (which means you cannot choose) to one of the three weight loss maintenance interventions: General Education, Increased Physical Activity, or Self-Regulation
- Available to take part in six 30-minute conference calls on either a Monday, Tuesday or Thursday starting at noon or 12:30pm. You will be given a toll-free call-in number so you can call from any location. The calls would be weekly for 4 weeks starting in June, and then there would be one call in mid-August and one in mid-September.
Who cannot join
- Not 18 or more years old.
- Did not participate in the 2007 Shape UP RI program
- Participated in 2007 Shape Up RI but lost less than 10 pounds in the program.
- Currently or plan to become pregnant in the next 4 months.
- Currently participating in another weight loss or exercise study.
- Not available to take part in six 30-minute conference calls on either a Monday, Tuesday or Thursday starting at noon or 12:30pm. The calls would be weekly for 4 weeks starting in June, and then there would be one call in mid-August and one in mid-September.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control and Diabetes Research Center/The Miriam Hospital
Providence, Rhode Island, 02903
About this study
Official title: Evaluation of the 2007 Shape Up RI Campaign: Study 3 Maintenance
This study will focus on maintenance of weight loss achieved in the 2007 Shape-Up Rhode Island(SURI)program. We plan to recruit 180 individuals who participated in SURI and lost at least 10 pounds to take part in a 4-month weight loss maintenance program when the SURI ends. Participants will be randomly assigned to one of three groups: Education, Increased Exercise, or Daily Self-Weighing.
- Conditions
- Weight Loss
- Being tested
- Increased Exercise for weight loss maintenance, Daily Self-weighing for weight loss maintenance, Education for weight loss maintenance
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased Exercise for weight loss maintenanceBehavioural
Daily Self-weighing for weight loss maintenanceBehavioural
Education for weight loss maintenanceBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Rena R Wing, Ph.D, Principal investigator, Lifespan/ The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466141
- Sponsor's protocol ID
- 2097-07
- Acronym
- STOPRegain
- Status last verified
- Apr 2007
- First submitted
- 24 Apr 2007
- Last updated
- 23 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the 2007 Shape Up RI Campaign: Study 3 Maintenance
- ClinicalTrials.gov ID
- NCT00466141
- Acronym / sponsor ID
- STOPRegain / 2097-07
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 27 Apr 2007 (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.
This study will focus on maintenance of weight loss achieved in the 2007 Shape-Up Rhode Island(SURI)program. We plan to recruit 180 individuals who participated in SURI and lost at least 10 pounds to take part in a 4-month weight loss maintenance program when the SURI ends. Participants will be randomly assigned to one of three groups: Education, Increased Exercise, or Daily Self-Weighing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are 18 years or older
- Lost 10 or more pounds during the 2007 Shape Up RI program
- Want to learn skills to maintain your weight loss
- Can come to the Weight Control and Diabetes Research Center located at 196 Richmond Street in the "The Jewelry District" of Providence for a baseline assessment visit in mid-May/mid-June and final assessment visit in mid-October.
- Agree to be randomly assigned (which means you cannot choose) to one of the three weight loss maintenance interventions: General Education, Increased Physical Activity, or Self-Regulation
Key exclusion criteria (6 listed)
- Not 18 or more years old.
- Did not participate in the 2007 Shape UP RI program
- Participated in 2007 Shape Up RI but lost less than 10 pounds in the program.
- Currently or plan to become pregnant in the next 4 months.
- Currently participating in another weight loss or exercise 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 |
|---|---|---|
| Increased Exercise for weight loss maintenance | Behavioural | – |
| Daily Self-weighing for weight loss maintenance | Behavioural | – |
| Education for weight loss maintenance | Behavioural | – |
Primary outcome
Not reported in the source record.
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 23 Jan 2008.
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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, Ph.D principal investigator
Lifespan/ 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 study testing Increased Exercise for weight loss maintenance, Daily Self-weighing for weight loss maintenance and Education for weight loss maintenance in people with Weight Loss, 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 6 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 23 Jan 2008. 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.
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 23 Jan 2008.