ObesityNCT00948415
Evaluation of the Shape Up Rhode Island Campaign Study 5
A study testing Evaluation of the Shape Up RI Campaign in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
Obesity is a major health problem that has reached epidemic levels. Efforts are needed to develop cost-effective public health approaches for weight loss and maintenance. One such approach is to develop team-based programs that may motivate people to lose weight and/or increase their physical activity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Evaluation of the Shape Up RI Campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2010
- 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
- Overweight or obese
- Current participant in the Shape Up RI program weight loss competition
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Shape Up Rhode Island Campaign Study 5: Does Adding Behavioral Weight Control Information to Shape-Up Rhode Island Improve Outcomes?
Obesity is a major health problem that has reached epidemic levels. Efforts are needed to develop cost-effective public health approaches for weight loss and maintenance. One such approach is to develop team-based programs that may motivate people to lose weight and/or increase their physical activity. One such program is entitled Shape-up Rhode Island (SURI). The current trial is investigating whether adding both a behavioral intervention delivered online PLUS automated feedback to self-monitoring would enhance the outcomes of SURI participants.
Read the detailed description
Background: Given the epidemic of obesity, approaches to weight loss that can be applied on a community, state, or national level are needed. This project is an ongoing evaluation of Shape Up Rhode Island (SURI) program, a state-wide Internet based program involving team-based competition to increase physical activity and achieve weight loss.
Aim: To enhance the effectiveness of SURI utilizing a minimal contact intervention delivered online.
Design: SURI 2009 participants were invited to join a research study focusing on weight loss. Interested participants were randomized to two groups including a SURI Enhanced group (behavioral intervention presented in 12 weekly online presentations, daily self-monitoring, and weekly automated feedback) or a SURI Standard group (group given a list of previously existing online resources to aid with weight loss).
- Conditions
- Obesity
- Being tested
- Evaluation of the Shape Up RI Campaign
- Keywords
- Obesity, Weight loss, Internet
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the Shape Up RI CampaignBehavioural
The SURI enhanced group will receive the standard Shape Up RI program. In addition, participants will be asked to record and report their daily calorie intake, body weight, minutes of physical activity, and pedometer steps. Participants will receive automated feedback on progress as well as a behavioral lesson delivered online during each week of the program. Participants assigned to the SURI Standard arm will receive the standard Shape Up RI program. The intervention will take place during the 12-week Shape Up RI campaign.
| Study group | Role | What they receive |
|---|---|---|
| SURI Enhanced | Experimental | Not described Receives: Behavioral: Evaluation of the Shape Up RI Campaign |
| SURI Standard | Active comparator | Not described Receives: Behavioral: Evaluation of the Shape Up RI Campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss at the end of Shape Up RI
Measured: 3 Months
Secondary outcomes (1)
Weight loss maintenance 6 months after program completion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionDec 2010
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948415
- Sponsor's protocol ID
- 2097-07 Study 5
- Status last verified
- Jul 2014
- First submitted
- 27 Jul 2009
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Shape Up Rhode Island Campaign Study 5: Does Adding Behavioral Weight Control Information to Shape-Up Rhode Island Improve Outcomes?
- ClinicalTrials.gov ID
- NCT00948415
- Acronym / sponsor ID
- 2097-07 Study 5
- Conditions
- Obesity
- Keywords
- Obesity, Weight loss, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Jul 2009 (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.
Obesity is a major health problem that has reached epidemic levels. Efforts are needed to develop cost-effective public health approaches for weight loss and maintenance. One such approach is to develop team-based programs that may motivate people to lose weight and/or increase their physical activity. One such program is entitled Shape-up Rhode Island (SURI). The current trial is investigating whether adding both a behavioral intervention delivered online PLUS automated feedback to self-monitoring would enhance the outcomes of SURI participants.
Detailed description
Background: Given the epidemic of obesity, approaches to weight loss that can be applied on a community, state, or national level are needed. This project is an ongoing evaluation of Shape Up Rhode Island (SURI) program, a state-wide Internet based program involving team-based competition to increase physical activity and achieve weight loss.
Aim: To enhance the effectiveness of SURI utilizing a minimal contact intervention delivered online.
Design: SURI 2009 participants were invited to join a research study focusing on weight loss. Interested participants were randomized to two groups including a SURI Enhanced group (behavioral intervention presented in 12 weekly online presentations, daily self-monitoring, and weekly automated feedback) or a SURI Standard group (group given a list of previously existing online resources to aid with weight loss).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SURI Enhanced | Experimental | Behavioral: Evaluation of the Shape Up RI Campaign |
| SURI Standard | Active comparator | Behavioral: Evaluation of the Shape Up RI Campaign |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Overweight or obese
- Current participant in the Shape Up RI program weight loss competition
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Evaluation of the Shape Up RI CampaignThe SURI enhanced group will receive the standard Shape Up RI program. In addition, participants will be asked to record and report their daily calorie intake, body weight, minutes of physical activity, and pedometer steps. Participants will receive automated feedback on progress as well as a behavioral lesson delivered online during each week of the program. Participants assigned to the SURI Standard arm will receive the standard Shape Up RI program. The intervention will take place during the 12-week Shape Up RI campaign. | Behavioural | SURI Enhanced, SURI Standard |
Primary outcome
Weight loss at the end of Shape Up RI
Time frame: 3 Months
1 secondary outcome
Weight loss maintenance 6 months after program completion
Time frame: 6 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 8 Jul 2014.
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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 study testing Evaluation of the Shape Up RI Campaign 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 1 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 8 Jul 2014. 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.
What does the primary outcome measure?
Weight loss at the end of Shape Up RI (time frame: 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 8 Jul 2014.