Physical Activity and Weight Loss to Improve Function and Pain After Total Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Change in body weight at 6 months
研究概览
简要总结
The purpose of this study is to examine if a weight loss program designed for adults after knee replacement improves weight loss, physical activity, pain, and function, as well as if the program is cost effective, as compared to a chronic disease self-management program.
详细描述
Participants will be randomized to either a weight loss program or chronic disease self-management program. Both programs will be phone-based and include phone calls with a health coach weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12. Monthly calls with occur between months 13-18. Assessments examining outcomes will be completed at baseline, 6, 12, and 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must:
- •have a body mass index between 25-45 kg/m2
- •have had a knee replacement (including primary, staged or independent bilateral, or revision) <6 months prior to baseline assessment
- •have a computer, tablet, or smartphone with active internet access to self-monitor online and/or have a device or computer compatible with Fitbit
- •completion of baseline assessment measures (height, weight, function tests, surveys, ≥4 days valid of activity monitoring, and 1 day of dietary recall)
- •be English-speaking and able to read consent and study materials written in English
- •be willing to attend 4 in-person assessments.
排除标准
- •have any contraindications to diet or weight loss
- •undergo simultaneous bilateral knee replacement or have a scheduled or anticipated knee replacement for the contralateral knee within the next 18 months
- •have a mobility limiting comorbidity unrelated to knee replacement (e.g. spinal stenosis, fibromyalgia, peripheral vascular disease, stroke)
- •are taking anti-obesity medications
- •are enrolled in a formal weight loss program
- •had or are planning to have bariatric/gastric/lap band surgery
- •are planning to relocate out of the Columbia or Greenville, SC areas in the next 18 months.
研究组 & 干预措施
PACE Weight Loss Program
Participants randomized to this arm will receive personalized diet, activity, and weight loss goals as well as tools to self-monitor behaviors and weight. To facilitate changes, participants will receive coaching calls weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12.
干预措施: PACE Weight Loss program (Behavioral)
Chronic Disease Self-Management Program
Participants randomized to this arm will receive a chronic disease self-management program including a self-management book. Participants will receive regular calls weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12.
干预措施: Chronic Disease Self-Management (Behavioral)
结局指标
主要结局
Change in body weight at 6 months
时间窗: 6 months
kg
次要结局
- Change in Chair Stands at 6 months(6 months)
- Change in WOMAC pain subscale at 18 months(18 months)
- Change in Chair Stands at 12 months(12 months)
- Change in Six Minute Walk Duration at 6 months(6 months)
- Change in WOMAC pain subscale at 6 months(6 months)
- Change in Timed Up & Go at 18 months(18 months)
- Change in Chair Stands at 18 months(18 months)
- Change in body weight at 12 months(12 months)
- Change in Six Minute Walk Duration at 18 months(18 months)
- Change in Timed Up & Go at 6 months(6 months)
- Change in body weight at 18 months(18 months)
- Change in WOMAC pain subscale at 12 months(12 months)
- Change in Six Minute Walk Duration at 12 months(12 months)
- Change in Timed Up & Go at 12 months(12 months)
- Change in Moderate to vigorous intensity physical activity at 6 months(6 months)
- Change in Moderate to vigorous intensity physical activity at 12 months(12 months)
- Change in Moderate to vigorous intensity physical activity at 18 months(18 months)
研究者
Christine A Pellegrini, PhD
Assistant Professor
University of South Carolina