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OpenTrials
Completed

NCT Number: NCT03614338

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Small changes weight loss program

Behavioral

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 outcomes

  1. Weight

    Time frame: 3 months

    Change from baseline using objectively measured body weight

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 3, 2018
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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