Empowered With Movement to Prevent Obesity and Weight Regain

Wake Forest University Health Sciences1 个研究点分布在 1 个国家目标入组 183 人开始时间: 2016年12月6日最近更新: 2022年3月23日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Wake Forest University Health Sciences
入组人数: 183
试验地点: 1
主要终点: Body Weight

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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