Clinical trial NCT03104205: MOWI Home-Based Pilot
Official title: Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Home-Based Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: frail elderly
telemedicine
obesity
rural health
health promotion
weight loss
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-04-07
Enrollment: 58
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single arm pilot intervention
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Grip Strength
timeFrame: Change between baseline and follow-up at 26-weeks
measure: Change in 30 Second Sit-to-Stand (STS)
timeFrame: Change between baseline and follow-up at 26-weeks
measure: Change in Six-Minute Walk Test (6MWT)
timeFrame: Change between baseline and follow-up at 26-weeks
measure: Change in Gait Speed (Meters Per Second)
timeFrame: Change between baseline and follow-up at 26-weeks
measure: Change in Late-Life Function and Disability Instrument (LLFDI)
timeFrame: Change between baseline and follow-up at 26-weeks
Secondary outcomes:
measure: Behavioral Activation (Patient Activation Measure)
timeFrame: baseline and follow-up at 26-weeks
measure: Subjective Health Status (PROMIS)
timeFrame: Change between baseline and follow-up at 26-weeks
measure: Change in Weight in kg
timeFrame: Change between baseline and follow-up at 26-weeks
measure: Change in Body Mass Index (BMI) in kg/m^2
timeFrame: Change between baseline and follow-up at 26-weeks
measure: Change in Waist Circumference in cm
timeFrame: Change between baseline and follow-up at 26-weeks
measure: Steps
timeFrame: Change between baseline and follow-up at 26-weeks
measure: Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) -
timeFrame: Change between baseline and follow-up at 26-weeks
measure: Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week
timeFrame: Change between baseline and follow-up at 26-weeks
measure: Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week
timeFrame: Change between baseline and follow-up at 26-weeks
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center / Dartmouth Medical School
name: John A Batsis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Batsis JA, Petersen CL, Clark MM, Cook SB, Kotz D, Gooding TL, Roderka MN, Al-Nimr RI, Pidgeon D, Haedrich A, Wright KC, Aquila C, Mackenzie TA. Feasibility and acceptability of a technology-based, rural weight management intervention in older adults with obesity. BMC Geriatr. 2021 Jan 12;21(1):44. doi: 10.1186/s12877-020-01978-x.