Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Change in Grip Strength
研究概览
简要总结
The goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology-assisted wellness intervention for older adults with obesity.
详细描述
The national epidemic of obesity is also affecting older adults, and is associated with an increased risk of disability, nursing home placement and early mortality. Conventional weight loss programs have the potential to reduce body fat, but are difficult to access for older obese adults due to transportation and mobility challenges. The overarching goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology assisted wellness intervention for older adults with obesity.
Study Timeline:
September 2017 to June 2018:
Goal: Conduct a pilot study of improving weight and physical function in older adults with obesity. An mHealth Obesity Wellness Intervention (MOWI) will integrate Amulet +/- Fitbi with a weekly individual dietician-led nutritional session, along with twice weekly physical therapist led group exercise session.
Participation Duration: Three times weekly for 3 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥65 years
- •Body Mass Index (BMI) ≥ 30kg/m^2
- •Waist circumference ≥88cm in females or ≥102cm in males
- •Aims 2 & 3:
- •Have Wi-Fi high speed internet
- •Able to obtain medical clearance from doctor
- •Have less than a 5% weight loss in past 6 months
- •No advanced co-morbidity
- •No exercise restrictions
- •Not involved in other research studies that may interfere with participation
排除标准
- •Severe mental or life-threatening illness
- •Substance use
- •History of bariatric surgery
- •Suicidal ideation
- •Unable to perform measures
- •Reside in nursing home
- •No advanced co-morbidity
- •No exercise restrictions
- •Not involved in other research studies that may interfere with participation
- •Aim 4 - had to have completed Aims 2 or 3
结局指标
主要结局
Change in Grip Strength
时间窗: Baseline, 12 weeks
Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.
Change in Six-Minute Walk Test (6MWT)
时间窗: Baseline, 12 weeks
A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m
Change in Gait Speed (m/s)
时间窗: Baseline, 12 weeks
Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (significant change 0.1 m/s).
Change in 5 Times Sit-to-Stand (STS)
时间窗: Baseline, 12 weeks
STS measures lower limb strength (minimal change 2.3 s).
Change in Late-Life Function and Disability Instrument (LLFDI)
时间窗: Baseline, 12 weeks
LLFDI consists of a 32-item function and 16-item disability (life-task) scales that correlate with gait speed and lower limb function. Higher points indicate better function. Individual raw scores range from 0 to 80, scaled scores are 0 to 100. Each was assessed at baseline and at 12 weeks. We report the differences between baseline/follow-up. Positive score change reflect improved physical function.
次要结局
- Change in C-peptide(Baseline, 12 weeks)
- Change in Interleukin 6(Baseline, 12 weeks)
- Change in Behavioral Activation (Patient Activation Measure)(Baseline, 12 weeks post study)
- Change in Energy Expenditure(Baseline to 12 weeks)
- Change in Participant Satisfaction Questionnaire Score(Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)))
- Change in Insulin Level(Baseline, 12 weeks)
- Change in Waist Circumference in cm(Baseline, 12 weeks post study)
- Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Activities(Change Score between baseline and 12 weeks)
- Change in Credibility and Expectancy Questionnaire Score(Baseline (of maintenance intervention) and 6 months (into maintenance) - pre/post)
- Change in Subjective Health Status (PROMIS) Physical(Baseline, 12-weeks)
- Change in Weight in kg(Baseline, 12 weeks)
- Average Steps/Expenditure(Mean steps over 12 week period of time)
- Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Not Exercising Activities(Change Score between baseline and 12 weeks)
- Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS)(Change in KCal between baseline and 12 weeks)
- Change in C-reactive Protein(Baseline, 12 weeks)
- Change in Tumor Necrosis Factor Alpha(Baseline, 12 weeks)
- Change in Body Composition - Lean Mass(Baseline, 12 weeks)
- Change in Fasting Plasma Glucose(Baseline, 12 weeks)
- Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration(Change Score between baseline and 12 weeks)
研究者
John A. Batsis, MD
Associate Professor
Dartmouth-Hitchcock Medical Center