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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03614338
Other study ID # 18070904
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 3, 2019
Est. completion date August 15, 2019

Study information

Verified date August 2019
Source Rush University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date August 15, 2019
Est. primary completion date May 8, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. BMI 25-45 kg/m2

2. Age 18-75

3. Attend one of the West Side partnership churches at least 2 times per month

4. Able to attend in-person meetings

5. Willing to share their experiences on the West Side ALIVE Facebook page

Exclusion Criteria:

1. Blood pressure > 170/90 (self-report or during the WSA screening)

2. Diabetes treated with insulin

3. History of cancer within the past 5 years

4. Pregnancy or breastfeeding in the last 6 months, planning to become pregnant in the next 3 months

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Small changes weight loss program
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.

Locations

Country Name City State
United States Rush University Medical Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Program satisfaction Self-reported program satisfaction post-intervention 3 months
Other Program engagement Number of sessions attended during intervention 3 months
Primary Weight Change from baseline using objectively measured body weight 3 months
Secondary Blood pressure Change from baseline 3 months
Secondary Physical activity Change from baseline in total minutes of MVPA assessed by accelerometer 3 months
Secondary Weight loss strategies Change from baseline on self-reported use of weight loss strategies 3 months
Secondary Weight Change from baseline using objectively measured body weight 6 months
Secondary HbA1c Change from baseline using a point of care analyzer 3 months
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