New Media Obesity Treatment in Community Health Centers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 2
- 主要终点
- Weight change
研究概览
简要总结
This purpose of this trial is to determine whether a 12-month eHealth behavioral intervention that includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls, and primary care physician (PCP) counseling will produce greater weight change at 12 months than a standard primary care control.
详细描述
This is a patient randomized trial in which patients will be randomized into one of two treatment arms: 1) standard primary care; or 2) primary care plus a 12-month eHealth behavioral intervention (iOTA), which includes interactive self-monitoring and feedback, tailored skills training materials, 18 telephone counseling calls, and primary care provider counseling. The primary outcome is weight change at 12 months. Participants will be 351 adult male and female patients from local community health centers with obesity and a related comorbidity.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 1 visit in the previous 12 months to an adult medicine, internal medicine, or family practice provider at a participating community health center
- •BMI between 30.0-45.0 kg/m2 and weight ≤ 320 pounds
- •Diagnosis of hypertension or diabetes
排除标准
- •Current pregnancy
- •Pregnancy in previous 12 months
- •Heart attack/stroke in previous 2 years
- •Active cancer diagnosis
- •Current participation in another weight loss study
研究组 & 干预措施
eHealth weight loss intervention
The 12-month eHealth behavioral intervention includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls from a study coach, and primary care provider counseling.
干预措施: eHealth weight loss intervention (Behavioral)
Usual care
Participants in the usual care arm will receive the usual primary care services offered by their community health center primary care providers.
结局指标
主要结局
Weight change
时间窗: Baseline - 12 months
Weight will be measured at baseline and 12 months using a SECA 876 scale.
次要结局
- Global Framingham risk score(Baseline - 12 months)
- Physical activity(Baseline -12 months)
- The achievement and maintenance of > 5% weight loss(Baseline - 12 months)
- An evaluation of the intervention's impact and dissemination potential using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework(12 and 24 months)
- Diet(Baseline - 12 months)
- Cardiometabolic risk markers(Baseline - 12 months)