N/A
Completed N=7
"GameDay Ready": Evaluating a Behavioral Weight Management Program for Black Men Living in the Rural South
Obesity · Physical Inactivity · Diet, Healthy
Source: ClinicalTrials.gov NCT05530980 ↗
Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Study Interest — 91 Number of people
Summary
The primary objective of this study is to test the feasibility and acceptability of a 12-week behavioral weight management intervention adapted for Black men living in the rural South. The intervention is guided by Self-Determination Theory of Motivation, Social Cognitive Theory, and Ecological Systems Theory. Key aspects of the intervention include a football-themed curriculum, facilitator and peer concordance to the extent possible (ie., similarly aged Black men), an emphasis on male-specific health concerns, group-based competition at multiple levels of the intervention (e.g., during in-person physical activity sessions and for achieving behavioral goals), a limited educational component, and physical activity being a substantial component of meeting sessions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study Interest |
91 | — |
| PRIMARY Eligibility |
14 | — |
| PRIMARY Time to Enroll |
5 | — |
| PRIMARY Attendance |
49; 57; 67 | — |
| PRIMARY Attrition |
5; 4 | — |
| SECONDARY Change in Weight |
— | — |
| SECONDARY Change in Body Mass Index |
— | — |
| SECONDARY Change in Waist Circumference |
— | — |
| SECONDARY Change in Blood Pressure |
— | — |
| SECONDARY Change in Moderate-to-vigorous Physical Activity |
— | — |
| SECONDARY Dietary Intake |
— | — |
| SECONDARY Social Support for Diet and Physical Activity |
— | — |
| SECONDARY Environmental Support for Physical Activity |
— | — |
| SECONDARY Motivation for Weight Loss |
— | — |
| SECONDARY Motivation for Healthy Eating |
— | — |
| SECONDARY Motivation for Physical Activity |
— | — |
| SECONDARY Self-efficacy for Exercise |
— | — |
| SECONDARY Neighborhood Surroundings |
— | — |
| SECONDARY Neighborhood Safety |
— | — |
| SECONDARY Relatedness to Others in Physical Activity |
— | — |
Eligibility Criteria
Inclusion Criteria
- Self-identified African American or Black American male
- BMI 27kg/m^2 to 50kg/m^2 (healthcare provider approval required for those with a BMI >45)
- Able to speak and understand English
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 intervention, 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 surgery
- Have been treated for cancer in the past 12 months (other than non-melanoma skin cancer)
- Weight loss ≥5% during the past 6 months
- Any other perceived physical or mental health-related condition that would preclude participating in a behavioral program designed to promote weight loss
- Intending to move within 6 months
Data sourced from ClinicalTrials.gov (NCT05530980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.