Back to resultsA Small Changes Weight Loss Program and Message Dissemination Via Facebook in Chicago's West Side
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Small changes weight loss program
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- BMI 25-45 kg/m2
- Age 18-75
- Attend one of the West Side partnership churches at least 2 times per month
- Able to attend in-person meetings
- Willing to share their experiences on the West Side ALIVE Facebook page
Exclusion Criteria:
- Blood pressure > 170/90 (self-report or during the WSA screening)
- Diabetes treated with insulin
- History of cancer within the past 5 years
- Pregnancy or breastfeeding in the last 6 months, planning to become pregnant in the next 3 months
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Core Participants Weight Loss Program
Arm Description
Small changes weight loss program
Outcomes
Primary Outcome Measures
Weight
Change from baseline using objectively measured body weight
Secondary Outcome Measures
Blood pressure
Change from baseline
Physical activity
Change from baseline in total minutes of MVPA assessed by accelerometer
Weight loss strategies
Change from baseline on self-reported use of weight loss strategies
Weight
Change from baseline using objectively measured body weight
HbA1c
Change from baseline using a point of care analyzer
Full Information
NCT ID
NCT03614338
First Posted
July 30, 2018
Last Updated
August 15, 2019
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03614338
Brief Title
A Small Changes Weight Loss Program and Message Dissemination Via Facebook in Chicago's West Side
Official Title
A Small Changes Weight Loss Program and Message Dissemination Via Facebook in Chicago's West Side
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
May 8, 2019 (Actual)
Study Completion Date
August 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
African-American communities experience a greater burden of obesity-related diseases such as type 2 diabetes mellitus and cardiovascular disease and higher rates of obesity, compared to other race groups. There is a need for interventions that show promise in mitigating these disparities. The primary goal of this project is to pilot test whether an existing "small-changes" intervention for weight loss can be modified and delivered within the West Side ALIVE churches.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Core Participants Weight Loss Program
Arm Type
Experimental
Arm Description
Small changes weight loss program
Intervention Type
Behavioral
Intervention Name(s)
Small changes weight loss program
Intervention Description
This intervention uses a "small-changes" approach to calorie reduction (operationalized as 6 100-calories changes per day) along with increasing leisure-time physical activity and self-regulation strategies to produce weight loss. The intervention will be delivered via 12 face-to-face group sessions.
Primary Outcome Measure Information:
Title
Weight
Description
Change from baseline using objectively measured body weight
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Change from baseline
Time Frame
3 months
Title
Physical activity
Description
Change from baseline in total minutes of MVPA assessed by accelerometer
Time Frame
3 months
Title
Weight loss strategies
Description
Change from baseline on self-reported use of weight loss strategies
Time Frame
3 months
Title
Weight
Description
Change from baseline using objectively measured body weight
Time Frame
6 months
Title
HbA1c
Description
Change from baseline using a point of care analyzer
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Program satisfaction
Description
Self-reported program satisfaction post-intervention
Time Frame
3 months
Title
Program engagement
Description
Number of sessions attended during intervention
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI 25-45 kg/m2
Age 18-75
Attend one of the West Side partnership churches at least 2 times per month
Able to attend in-person meetings
Willing to share their experiences on the West Side ALIVE Facebook page
Exclusion Criteria:
Blood pressure > 170/90 (self-report or during the WSA screening)
Diabetes treated with insulin
History of cancer within the past 5 years
Pregnancy or breastfeeding in the last 6 months, planning to become pregnant in the next 3 months
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Small Changes Weight Loss Program and Message Dissemination Via Facebook in Chicago's West Side
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