MOWI Home-Based Pilot

NCT03104205 | Completed Results DMC

• 2 other identifiers: D16182_3K23AG051681
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

frail elderly; telemedicine; obesity; rural health; health promotion; weight loss

Outcome Measures

Primary Outcomes (5)

• Change in Grip Strength

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

  Change between baseline and follow-up at 26-weeks

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

  STS measures lower limb strength - change represented as repetitions.

  Change between baseline and follow-up at 26-weeks

• Change in Six-Minute Walk Test (6MWT)

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

  Change between baseline and follow-up at 26-weeks

• Change in Gait Speed (Meters Per Second)

  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 between baseline and follow-up at 26-weeks

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

  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 between baseline and follow-up at 26-weeks

Secondary Outcomes (9)

• 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 Weight in kg

  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

• Change in Waist Circumference in cm

  Change between baseline and follow-up at 26-weeks

Study Arms (1)

Evaluate home-based MOWI

EXPERIMENTAL

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

Behavioral: Evaluate home-based MOWI

Interventions

Evaluate home-based MOWI BEHAVIORAL

MOWI will be delivered via video-conferencing in the subject's home in a 3x per week, 26-week program from the coordinating center. It will include an individual dietician-led weekly nutrition session; 2x/week physical therapist-led group exercise session; and remote fitness device monitoring. We plan 5 cohorts of 8 subjects (n=40). In-person Research Assistant-led assessments will occur at 0, 8, 16 and 26 weeks. Recruitment, screening, selection criteria, and usability parallel Aim 2 (NCT03104192).

Evaluate home-based MOWI

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Related Publications (1)

• 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.

  PMID: 33435877 DERIVED

Related Links

• Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Amulet Technology Development \& Validation
• Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Qualitative Assessment
• Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: John A. Batsis
• Organization: Dartmouth-Hitchcock

john.a.batsis@hitchcock.org

6036505000

Study Officials

• John A Batsis, MD

  Dartmouth-Hitchcock Medical Center / Dartmouth Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and of The Dartmouth Institute Geisel School of Medicine at Dartmouth

Model Details: A single arm pilot intervention

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 7, 2017
• Study Start: October 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 31, 2021
• Last Updated: June 12, 2023
• Results First Posted: December 20, 2021

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)