NCT05970042Active, not recruitingNot Applicable
Developing a Lifestyle Intervention to Reduce Body Weight for Obese African American Men Living in the Rural South
University of South Carolina2 sites in 1 country29 target enrollmentStarted: August 4, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of South Carolina
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- Body weight
Study Overview
Brief Summary
This pilot study investigates the effects of a newly developed 12-week weight management program called "GameDay Ready" (compared to a walking and general health education program) for decreasing body weight among Black men who live in the rural South. The researchers expect to see evidence of greater weight loss among participants randomized to receive the "GameDay Ready" program.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Self-identified African American or Black American male
- •20-70 years of age
- •BMI 27kg/m2 to ≤50kg/m2 (those with a BMI >45 will need documented approval by a healthcare provider to participate in the study)
- •Live in a rural area of South Carolina and have lived in a rural area for at least 1 year
- •Able to speak and understand English
- •Willing to be randomized to the intervention or comparison program
Exclusion Criteria
- •Positive response to any question on the Physical Activity Readiness Questionnaire (PAR-Q) (Participant may be included if approval is provided and documented by a healthcare provider)
- •Currently participating in another weight loss trial or program or have participated in a trial or program within 6 months prior to starting the intervention
- •Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg), diabetes, or asthma (Participant may be included if approval is provided and documented by a healthcare provider)
- •Pulmonary disease requiring supplemental oxygen or daily use of short-acting bronchodilators
- •Any musculoskeletal condition that would preclude meeting recommended levels of moderate-to- vigorous physical activity
- •Within 30 days prior to participating in the study, have taken prescription or nonprescription medications, herbals, or supplements for weight loss
- •On special diet for a serious health condition (does not include general dietary advice from a healthcare provider for common risk factors such as hypertension, diabetes, or hyperlipidemia).
- •Major surgery in the past 6 months
- •Have undergone weight loss surgery or considering weight loss surgery within the next 6 months
- •Have been treated for cancer in the past 12 months (other than non-melanoma skin cancer)
- •Weight loss ≥5% during the past 6 months
- •Plans to move to another county in the next 6 months
- •Any other perceived physical or mental health-related condition that would preclude participating in a behavioral program designed to promote weight loss
Arms & Interventions
GameDay Ready Program
Experimental
GameDay Ready is a 12-week, group-based behavioral weight management program.
Intervention: GameDay Ready (Behavioral)
Walking and General Health Education Program
Active Comparator
The walking and general health education program is a 12-week, group-based program that addresses common chronic health conditions that affect men.
Intervention: Walking and General Health Education (Behavioral)
Outcomes
Primary Outcomes
Body weight
Time Frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
Participants' body weight will be measured in pounds using a portable, professional-grade scale. Changes in body weight will be compared between the intervention and comparison programs.
Secondary Outcomes
- Added sugar consumption(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Moderate-to-vigorous physical activity (MVPA)(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Whole grain consumption(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Social support for exercise and diet(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Motivation for weight loss(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Blood pressure (BP)(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Fruit and vegetable consumption(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Body mass index (BMI)(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Waist circumference (WC)(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Motivation for physical activity(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Perceived stress(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Perceived environmental support for physical activity(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Motivation for healthy eating(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Exercise self-efficacy(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Relatedness to others in physical activity(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
Investigators
Demetrius Abshire
Associate Professor
University of South Carolina
Study Sites (2)
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