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Clinical Trials/NCT03104205
NCT03104205CompletedNot Applicable

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

Dartmouth-Hitchcock Medical Center1 site in 1 country58 target enrollmentStarted: October 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
58
Locations
1
Primary Endpoint
Change in 30 Second Sit-to-Stand (STS)

Study Overview

Brief Summary

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.

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

Evaluate home-based MOWI

Experimental

Conduct and assess the feasibility, acceptability, and potential effectiveness of home-based MOWI in improving physical function.

Intervention: Evaluate home-based MOWI (Behavioral)

Outcomes

Primary Outcomes

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

Time Frame: Change between baseline and follow-up at 26-weeks

STS measures lower limb strength - change represented as repetitions.

Change in Grip Strength

Time Frame: 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)

Time Frame: 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 Late-Life Function and Disability Instrument (LLFDI)

Time Frame: 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)

Time Frame: 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

Secondary Outcomes

  • Change in Body Mass Index (BMI) in kg/m^2(Change between baseline and follow-up at 26-weeks)
  • 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)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

John A. Batsis, MD

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

Dartmouth-Hitchcock Medical Center

Study Sites (1)

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