Promoting Weight-Loss in African American Cancer Survivors in the Deep South
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 369
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
This study tests evidence-based strategies for weight loss among overweight and obesity cancer survivors and family members in rural Alabama.
详细描述
This is a 3-arm cluster randomized controlled study that compares a trained lay provided weight loss program vs. the same program plus community-based weight management strategies vs. general cancer prevention education on weight loss and other clinical outcomes (primary outcomes) and healthy behaviors, and psychosocial functioning (secondary outcomes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Single Blind (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •African American breast, colon, or prostate cancer survivor (Index Participant)
- •Family member (support person) of African American breast, colon, or prostate cancer survivor (Family Member Participant)
- •Live, work, or attend school in target county
- •BMI >= 25 kg/m2
排除标准
- •Pregnant or planning to become pregnant in the next year
- •Known major medical or psychological condition known to influence body weight
- •Uncontrolled hypertension (BP > 160 mmHg systolic or >100 mmHg diastolic)
- •medicated or poorly controlled diabetes (glucose > 126) Cardiovascular event in the preceding 12 months
- •History of gastric bypass or bariatric surgery
- •History of psychiatric hospitalization in past 2 years
- •History of substance abuse or eating disorder
- •Any other condition by which a medical professional has suggested diet modification, physical activity and/or weight reduction would be contraindicated
研究组 & 干预措施
Weight Loss Only
Group-based behavioral weight loss intervention designed to reach clinically significant weight loss (~5-10% of baseline weight).
干预措施: Weight Loss Only (Behavioral)
Weight Loss Plus
Group-based behavioral weight loss intervention designed to reach clinically significant weight loss (~5-10% of baseline weight) plus community-level strategies to support healthy weight. Strategies are based on CDC's recommended community strategies and are developed by local contractors. They include expanded farmers markets/gardens, improvement to walking trails, etc.
干预措施: Weight Loss Plus (Behavioral)
Control
Educational materials and optional participation in community-wide cancer awareness activities.
干预措施: Control (Behavioral)
结局指标
主要结局
Weight
时间窗: Baseline to 6 months
Measured weight (nearest kg)
次要结局
- Waist Circumference(Baseline to 24 months)
- Lipids(Baseline to 24 months)
- Blood Pressure(Baseline to 24 months)
- Weight(Baseline to 24 months)
- Social Support for Diet and Exercise Behaviors(Baseline to 24 months)
- Self Efficacy for Diet and Exercise Behaviors(Baseline to 24 months)
- Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)(Baseline to 24 months)
研究者
Monica L Baskin
Principal Investigator
University of Alabama at Birmingham