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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04293055
Other study ID # 1561299
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 4, 2020
Est. completion date August 23, 2023

Study information

Verified date December 2023
Source The Miriam Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine whether weight loss maintenance can be improved by providing individuals with 4 consecutive weeks of phone coaching during the maintenance period. Individuals who previously achieved and maintained a >=5% weight loss in a 1-year behavioral weight loss program will be provided with a low-intensity maintenance intervention. Some individuals will be selected to receive phone coaching. Assessments of weight, physical activity, and other weight-related behaviors will occur at baseline, 6 months, and 1 year.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date August 23, 2023
Est. primary completion date August 23, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 72 Years
Eligibility Inclusion Criteria: - 18-72 years of age - Recent completion of a 1-year behavioral weight loss program - Achievement of >=5% weight loss at the end of the 1-year weight loss program Exclusion Criteria: - Not currently enrolled in another weight management program

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Maintenance program
1-year weight loss maintenance program, consisting of monthly newsletters
Phone coaching
Some individuals will receive 4 consecutive weeks of phone coaching. The first coaching call will be approximately 30 minutes in duration and follow-up calls will be 10-15 minutes in duration. Coaches will help support participants in their weight loss maintenance efforts. Once coaching calls are completed, the participant will not have any other contact with their coach.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent weight change at 6 months 6 months after study enrollment
Primary Percent weight change at 12 months 12 months after study enrollment
Secondary Change in physical activity minutes (min/week) Physical activity will be assessed via an Actigraph accelerometer which is worn on the waist 12 months after study enrollment
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