Clinical trial NCT05970042: Investigating the Effects of the "GameDay Ready" Behavioral Weight Management Program for Black Men Living in the Rural South
Official title: Developing a Lifestyle Intervention to Reduce Body Weight for Obese African American Men Living in the Rural South
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-08-01
Enrollment: 30
Sex: MALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Self-identified African American or Black American male
* 25-65 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

Primary outcomes:
measure: Body weight
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
measure: Waist circumference (WC)
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
measure: Blood pressure (BP)
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
measure: Moderate-to-vigorous physical activity (MVPA)
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
measure: Fruit and vegetable consumption
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
measure: Added sugar consumption
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
measure: Whole grain consumption
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
measure: Social support for exercise and diet
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
measure: Perceived environmental support for physical activity
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
measure: Motivation for weight loss
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
measure: Motivation for healthy eating
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
measure: Motivation for physical activity
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
measure: Exercise self-efficacy
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
measure: Relatedness to others in physical activity
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
measure: Perceived stress
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
Other outcomes:
measure: Neighborhood surroundings
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
measure: Neighborhood safety
timeFrame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
References: