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临床试验/NCT03104205
NCT03104205已完成不适用

Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Home-Based Pilot

Dartmouth-Hitchcock Medical Center2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
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 2018 to April 2021:

Goal: Conduct a study of improving weight and physical function in older adults with obesity at home using video-conferencing. An mHealth obesity wellness intervention (MOWI) will integrate a fitness device with a weekly individual dietician-led nutritional session, along with twice weekly physical therapist led group exercise session performed in a person's home.

Participation Duration: Three times weekly for 6 months. We shall also have participants return to the center once monthly

研究设计

研究类型
Interventional
分配方式
Na
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

入选标准

  • Age ≥65 years
  • Body Mass Index (BMI) ≥ 30kg/m^2 OR Waist circumference ≥88cm in females or ≥102cm in males
  • 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

结局指标

主要结局

Change in Grip Strength

时间窗: Change between baseline and follow-up at 26-weeks

Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.

Change in Gait Speed (Meters Per Second)

时间窗: Change between baseline and follow-up at 26-weeks

Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (a significant change is considered 0.1 meters per second).

Change in 30 Second Sit-to-Stand (STS)

时间窗: Change between baseline and follow-up at 26-weeks

STS measures lower limb strength - change represented as repetitions.

Change in Late-Life Function and Disability Instrument (LLFDI)

时间窗: Change between baseline and follow-up at 26-weeks

LLFDI consists of a 32-item function and 16-item disability (life-task) scales that correlate with gait speed and lower limb function. For this instrument we use only the 32-item function and scores are scaled. Minimum 0, Maximum 100. Higher scores indicate higher levels of function

Change in Six-Minute Walk Test (6MWT)

时间窗: Change between baseline and follow-up at 26-weeks

A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m

次要结局

  • Change in Waist Circumference in cm(Change between baseline and follow-up at 26-weeks)
  • Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week(Change between baseline and follow-up at 26-weeks)
  • Change in Weight in kg(Change between baseline and follow-up at 26-weeks)
  • Steps(Change between baseline and follow-up at 26-weeks)
  • Behavioral Activation (Patient Activation Measure)(baseline and follow-up at 26-weeks)
  • Subjective Health Status (PROMIS)(Change between baseline and follow-up at 26-weeks)
  • Change in Body Mass Index (BMI) in kg/m^2(Change between baseline and follow-up at 26-weeks)
  • Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) -(Change between baseline and follow-up at 26-weeks)
  • Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week(Change between baseline and follow-up at 26-weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John A. Batsis, MD

Associate Professor of Medicine and of The Dartmouth Institute Geisel School of Medicine at Dartmouth

Dartmouth-Hitchcock Medical Center

研究点 (2)

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