Evaluation of the Shape Up Rhode Island Campaign: Study 4 Does Adding Behavioral Weight Control Information to Shape-Up Rhode Island Improve Outcomes?
Evaluation of the Shape Up Rhode Island Campaign
Sponsors
Source
The Miriam Hospital
Oversight Info
Has Dmc
No
Brief 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. One such program is entitled Shape-up Rhode Island (SURI).
The purpose of this project is to evaluate the overall effectiveness of SURI and to test if a
behavioral intervention can enhance the effectiveness of the original program. The current
trial is investigating whether adding a behavioral intervention delivered online 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 2008 participants were invited to join a research study focusing on weight loss.
Interested participants were randomized to two groups including a SURI Enhanced (behavioral
intervention presented in 12 weekly online presentations) or a SURI Standard group (group
given a list of previously existing online resources to aid with weight loss).
Overall Status
Completed
Start Date
2008-01-01
Completion Date
2010-12-01
Primary Completion Date
2010-12-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Weight loss at the end of Shape Up RI |
3 months |
Secondary Outcome
Measure |
Time Frame |
|
Weight loss maintenance 6 months after program completion |
6 months |
Enrollment
179
Condition
Intervention
Intervention Type
Behavioral
Intervention Name
Description
The SURI Standard group will receive all of the Shape-Up RI program materials plus an organized directory of useful websites related to healthy eating, exercise, and weight control. The SURI enhanced group will receive the standard Shape-Up RI program materials plus access to 12 behavioral weight loss lessons.
Arm Group Label
SURI Enhanced
SURI Standard
Eligibility
Criteria
Inclusion Criteria:
- Overweight or obese
- Current participant in the Shape Up RI program weight loss competition
Exclusion Criteria:
- None
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
|
Rena R Wing, Ph.D. |
Principal Investigator |
The Miriam Hospital |
Location
Facility |
|
The Miriam Hospital Providence Rhode Island 02906 United States |
Location Countries
Country
United States
Verification Date
2012-03-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
The Miriam Hospital
Investigator Full Name
Rena R. Wing
Investigator Title
Professor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
SURI Enhanced
Arm Group Type
Experimental
Arm Group Label
SURI Standard
Arm Group Type
Active Comparator
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Study First Submitted
November 14, 2008
Study First Submitted Qc
November 14, 2008
Study First Posted
November 18, 2008
Last Update Submitted
March 15, 2012
Last Update Submitted Qc
March 15, 2012
Last Update Posted
March 16, 2012
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.