MOWI Home-Based Pilot

Not Applicable

Completed

Conditions: Obesity

Interventions: Behavioral: Evaluate home-based MOWI

Registration Number: NCT03104205

Lead Sponsor: Dartmouth-Hitchcock Medical Center

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 58

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
Dementia
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Grip Strength	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)	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)	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)	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)	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 Outcome Measures

Name	Time	Method
Change in Waist Circumference in cm	Change between baseline and follow-up at 26-weeks	Change in waist circumference in cm
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week	Change between baseline and follow-up at 26-weeks	CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week.
Change in Weight in kg	Change between baseline and follow-up at 26-weeks	Change in weight in kg
Steps	Change between baseline and follow-up at 26-weeks	Fitibit will assess steps
Behavioral Activation (Patient Activation Measure)	baseline and follow-up at 26-weeks	Patient Activation Measure (PAM) assesses knowledge, confidence and skill for managing health and grouped into 4 levels revealing insights into attitudes, motivators, behaviors \& outcomes. Score ranges from 0 to 100, higher scores indicate higher activation.
Subjective Health Status (PROMIS)	Change between baseline and follow-up at 26-weeks	Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Short Form. PROMIS is a 10-item instrument capturing physical, mental and social aspects of quality of life having undergone quantitative appraisal and is non-proprietary. A score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate better health.
Change in Body Mass Index (BMI) in kg/m^2	Change between baseline and follow-up at 26-weeks	Change in body mass index (BMI) in kg/m\^2
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) -	Change between baseline and follow-up at 26-weeks	CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week.
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week	Change between baseline and follow-up at 26-weeks	CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week.