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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03614338
Recruitment Status : Completed
First Posted : August 3, 2018
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Melissa M. Crane, PhD, Rush University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Small changes weight loss program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Small Changes Weight Loss Program and Message Dissemination Via Facebook in Chicago's West Side
Actual Study Start Date : January 3, 2019
Actual Primary Completion Date : May 8, 2019
Actual Study Completion Date : August 15, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Weight [ Time Frame: 3 months ]
    Change from baseline using objectively measured body weight


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 3 months ]
    Change from baseline

  2. Physical activity [ Time Frame: 3 months ]
    Change from baseline in total minutes of MVPA assessed by accelerometer

  3. Weight loss strategies [ Time Frame: 3 months ]
    Change from baseline on self-reported use of weight loss strategies

  4. Weight [ Time Frame: 6 months ]
    Change from baseline using objectively measured body weight

  5. HbA1c [ Time Frame: 3 months ]
    Change from baseline using a point of care analyzer


Other Outcome Measures:
  1. Program satisfaction [ Time Frame: 3 months ]
    Self-reported program satisfaction post-intervention

  2. Program engagement [ Time Frame: 3 months ]
    Number of sessions attended during intervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614338


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
More Information
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Responsible Party: Melissa M. Crane, PhD, Assistant Professor, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03614338    
Other Study ID Numbers: 18070904
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight