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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00466141
Other study ID # 2097-07
Secondary ID
Status Completed
Phase N/A
First received April 24, 2007
Last updated January 21, 2008
Start date June 2007
Est. completion date October 2007

Study information

Verified date April 2007
Source The Miriam Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. Participants will be randomly assigned to one of three groups: Education, Increased Exercise, or Daily Self-Weighing.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Are 18 years or older

2. Lost 10 or more pounds during the 2007 Shape Up RI program

3. Want to learn skills to maintain your weight loss

4. 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.

5. 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

6. 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.

Exclusion Criteria:

1. Not 18 or more years old.

2. Did not participate in the 2007 Shape UP RI program

3. Participated in 2007 Shape Up RI but lost less than 10 pounds in the program.

4. Currently or plan to become pregnant in the next 4 months.

5. Currently participating in another weight loss or exercise study.

6. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Increased Exercise for weight loss maintenance

Daily Self-weighing for weight loss maintenance

Education for weight loss maintenance


Locations

Country Name City State
United States Weight Control and Diabetes Research Center/The Miriam Hospital Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

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