A Small Changes Weight Loss Program and Message Dissemination Via Facebook in Chicago's West Side

August 15, 2019 updated by: Melissa M. Crane, PhD, Rush University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Core Participants Weight Loss Program
Small changes weight loss program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 3 months
Change from baseline using objectively measured body weight
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 3 months
Change from baseline
3 months
Physical activity
Time Frame: 3 months
Change from baseline in total minutes of MVPA assessed by accelerometer
3 months
Weight loss strategies
Time Frame: 3 months
Change from baseline on self-reported use of weight loss strategies
3 months
Weight
Time Frame: 6 months
Change from baseline using objectively measured body weight
6 months
HbA1c
Time Frame: 3 months
Change from baseline using a point of care analyzer
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program satisfaction
Time Frame: 3 months
Self-reported program satisfaction post-intervention
3 months
Program engagement
Time Frame: 3 months
Number of sessions attended during intervention
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2019

Primary Completion (Actual)

May 8, 2019

Study Completion (Actual)

August 15, 2019

Study Registration Dates

First Submitted

July 30, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

August 19, 2019

Last Update Submitted That Met QC Criteria

August 15, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18070904

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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