NCT05970042进行中（未招募）不适用
Developing a Lifestyle Intervention to Reduce Body Weight for Obese African American Men Living in the Rural South
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Self-identified African American or Black American male
- •20-70 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
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 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
研究组 & 干预措施
GameDay Ready Program
Experimental
GameDay Ready is a 12-week, group-based behavioral weight management program.
干预措施: GameDay Ready (Behavioral)
Walking and General Health Education Program
Active Comparator
The walking and general health education program is a 12-week, group-based program that addresses common chronic health conditions that affect men.
干预措施: Walking and General Health Education (Behavioral)
结局指标
主要结局
Body weight
时间窗: Baseline, post-intervention (12 weeks), and 3 months post-intervention
Participants' body weight will be measured in pounds using a portable, professional-grade scale. Changes in body weight will be compared between the intervention and comparison programs.
次要结局
- Added sugar consumption(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Moderate-to-vigorous physical activity (MVPA)(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Whole grain consumption(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Social support for exercise and diet(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Motivation for weight loss(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Blood pressure (BP)(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Fruit and vegetable consumption(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Body mass index (BMI)(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Waist circumference (WC)(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Motivation for physical activity(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Perceived stress(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Perceived environmental support for physical activity(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Motivation for healthy eating(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Exercise self-efficacy(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
- Relatedness to others in physical activity(Baseline, post-intervention (12 weeks), and 3 months post-intervention)
研究者
Demetrius Abshire
Associate Professor
University of South Carolina
研究点 (1)
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