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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 25 Years and 65 Years
Eligible Sex
Male
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
GameDay Ready Program 		GameDay Ready is a 12-week, group-based behavioral weight management program.
  • Behavioral: GameDay Ready
    GameDay Ready is a 12-week, group-based behavioral weight management program in which participants will meet in-person once per week at a publicly accessible walking track. The GameDay Ready program promotes increasing physical activity, reducing sedentary time, and improving dietary habits through education, behavioral self-monitoring, and goal setting. Each 60-minute intervention session includes a brief educational component followed by a group discussion of weekly progress. Following a short warmup walk, participants engage in group-based competitive physical activities and then a short cooldown walk. Participants then set individual and group-based goals for the upcoming week and discuss strategies for overcoming barriers to achieving goals. The program is sensitive to intersectional influences of gender, race, and rurality on health; and strategies to enhance motivation are threaded throughout the program.
Active Comparator
Walking and General Health Education Program 		The walking and general health education program is a 12-week, group-based program that addresses common chronic health conditions that affect men.
  • Behavioral: Walking and General Health Education
    Participants receiving the comparison program will complete a 12-week walking and general health education program. Group sessions meet once per week at a publicly accessible walking track, and each 60-minute session consists of a brief educational component on a health topic followed by walking and socializing during the remainder of the session.

Recruiting Locations

University of South Carolina
Columbia 4575352, South Carolina 4597040 29208
Contact:
Demetrius A Abshire, PhD
803-576-6262
abshired@mailbox.sc.edu

More Details

NCT ID
NCT05970042
Status
Recruiting
Sponsor
University of South Carolina

Study Contact

Demetrius A Abshire, PhD
803-576-6262
abshired@mailbox.sc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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