Clinical trial NCT05530980: "GameDay Ready": Evaluating a 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: COMPLETED
Phase: NA
Conditions: Obesity
Physical Inactivity
Diet, Healthy
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-09-07
Enrollment: 7
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


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

Primary outcomes:
measure: Study Interest
timeFrame: Up to week 1
measure: Eligibility
timeFrame: Up to week 1
measure: Time to Enroll
timeFrame: Up to week 1
measure: Attendance
timeFrame: Baseline to 3 months
measure: Attrition
timeFrame: Baseline to 3 and 6 months
Secondary outcomes:
measure: Change in Weight
timeFrame: Change from baseline to 3 and 6 months
measure: Change in Body Mass Index
timeFrame: Change from baseline to 3 and 6 months
measure: Change in Waist Circumference
timeFrame: Change from baseline to 3 and 6 months
measure: Change in Blood Pressure
timeFrame: Change from baseline to 3 and 6 months
measure: Change in Moderate-to-vigorous Physical Activity
timeFrame: Change from baseline to 3 and 6 months
measure: Dietary Intake
timeFrame: Change from baseline to 3 and 6 months
measure: Social Support for Diet and Physical Activity
timeFrame: Change from baseline to 3 and 6 months
measure: Environmental Support for Physical Activity
timeFrame: Change from baseline to 3 and 6 months
measure: Motivation for Weight Loss
timeFrame: Change from baseline to 3 and 6 months
measure: Motivation for Healthy Eating
timeFrame: Change from baseline to 3 and 6 months
measure: Motivation for Physical Activity
timeFrame: Change from baseline to 3 and 6 months
measure: Self-efficacy for Exercise
timeFrame: Change from baseline to 3 and 6 months
measure: Neighborhood Surroundings
timeFrame: Change from baseline to 3 and 6 months
measure: Neighborhood Safety
timeFrame: Change from baseline to 3 and 6 months
measure: Relatedness to Others in Physical Activity
timeFrame: Change from baseline to 3 and 6 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Demetrius A Abshire, PhD
role: PRINCIPAL_INVESTIGATOR
References: