Empowered With Movement to Prevent Obesity and Weight Regain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 2
- 主要终点
- Body Weight
研究概览
简要总结
This study will help determine the appropriate type, amount and intensity of physical activity most beneficial for preventing weight regain after weight loss in older adults.
详细描述
The investigators will use a 3-group design in 180 older (65-85 years), obese (BMI=30-45 kg/m2), sedentary men and women, all of whom will undergo a 9-month Weight Loss (WL) intervention (6-mo intensive phase and 3-mo reduced contact phase), followed by a 9-month self-managed follow-up phase with minimal contact, to test our overall hypothesis that intervening on Sedentary Behavior (SitLess) will enhance long-term Weight Loss in this age group. The diet element of the intervention is identical across groups, but groups differ by activity intervention: 1) structured, moderate-intensity, aerobic exercise (EX) (WL+EX); 2) intervening on SB throughout the day (WL+SitLess); or 3) (WL+EX+SitLess).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65-85 years
- •BMI=30-45 kg/m2
- •Weight stable-no loss or gain (±5%) in past 6 mo
- •Sedentary
- •No contraindication for safe and optimal participation in exercise training
- •Approved for participation by Medical Director
- •Willing to provide informed consent
- •Agree to all study procedures and assessments
- •Able to provide own transportation to study visits and intervention
排除标准
- •Dependent on cane or walker
- •Reported unintentional or intentional weight loss or gain of >5% in past 6 mo Participation in regular resistance training and/or > 20 mins/day of aerobic exercise in past 6 months
- •Cognitive impairment (MoCA score <22)
- •Low bone density (T-score < -2.3 on hip or spine scan)
- •Severe arthritis, or other musculoskeletal disorder
- •Joint replacement or other orthopedic surgery in past 6 mos
- •Joint replacement or other orthopedic surgery planned in next 2 years
- •Uncontrolled resting hypertension (>160/90 mmHg);
- •Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease other than asthma or COPD, any disease requiring oxygen use, neurological or hematological disease; cancer requiring treatment in past year, except non-melanoma skin cancers
- •Serious conduction disorder, new Q waves or ST-segment depression (>3 mm), or uncontrolled arrhythmia
- •Room air SpO2 (oxygen saturation) at rest or with exercise qualifying for supplementary oxygen (SpO2≤88%)
- •Abnormal kidney or liver function (2x upper limit of normal);
- •eGFR <45 mL/min/1.73m2
- •Anemia (Hb<13 g/dL in men/ <12 g/dL in women);
- •Uncontrolled diabetes (fasting glucose >140 mg/dl);
- •Deficient levels of vitamin D (25 hydroxyvitamin D level < 20 ng/mL) in those not taking a vitamin D supplement;
- •Smoker (No nicotine in past yr)
- •No heavy alcohol use (>14 drinks/week)
- •Unstable severe depression
- •Regular use of: growth hormones, oral steroids, weight loss medications or prescription osteoporosis meds
- •Current participation in other research study
结局指标
主要结局
Body Weight
时间窗: 18 months
Measured in clinic on the same scale
次要结局
未报告次要终点