Developing a Lifestyle Intervention to Reduce Body Weight for Obese African American Men Living in the Rural South
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Study Interest
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
GameDay Ready Program
The GameDay Ready Program is a 12-week, football-themed, behavioral weight management intervention that promotes gradual increases in physical activity, reductions in sedentary time, and improvements in dietary habits through education, self-monitoring of physical activity and diet, personalized goal setting, group-based competition, social support, identifying and overcoming barriers, and including physical activity as a substantial component of meeting sessions. The program is sensitive to unique cultural influences surrounding gender, race, and rurality; and issues related to motivation are threaded throughout the program.
干预措施: GameDay Ready Program (Behavioral)
结局指标
主要结局
Study Interest
时间窗: Up to week 1
Number of people expressing interest in the study
Attendance
时间窗: Baseline to 3 months
Number and proportion of enrolled men who attend each intervention session and total number of sessions. Percentage of sessions attended calculated as the total number of sessions attended divided by total number of sessions offered.
Time to Enroll
时间窗: Up to week 1
Length of time needed to enroll the desired sample size (length of time reflects when recruitment was initiated until study launch)
Attrition
时间窗: Baseline to 3 and 6 months
Number and percentage of enrolled men who withdraw from the study
Eligibility
时间窗: Up to week 1
Number of men who express interest in the study and are eligible.
次要结局
- Social Support for Diet and Physical Activity(Change from baseline to 3 and 6 months)
- Change in Weight(Change from baseline to 3 and 6 months)
- Motivation for Physical Activity(Change from baseline to 3 and 6 months)
- Neighborhood Surroundings(Change from baseline to 3 and 6 months)
- Neighborhood Safety(Change from baseline to 3 and 6 months)
- Change in Body Mass Index(Change from baseline to 3 and 6 months)
- Change in Waist Circumference(Change from baseline to 3 and 6 months)
- Dietary Intake(Change from baseline to 3 and 6 months)
- Environmental Support for Physical Activity(Change from baseline to 3 and 6 months)
- Motivation for Healthy Eating(Change from baseline to 3 and 6 months)
- Self-efficacy for Exercise(Change from baseline to 3 and 6 months)
- Change in Moderate-to-vigorous Physical Activity(Change from baseline to 3 and 6 months)
- Motivation for Weight Loss(Change from baseline to 3 and 6 months)
- Change in Blood Pressure(Change from baseline to 3 and 6 months)
- Relatedness to Others in Physical Activity(Change from baseline to 3 and 6 months)
研究者
Demetrius Abshire
Assistant Professor
University of South Carolina