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Completed

NCT Number: NCT03104205

MOWI Home-Based Pilot

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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).

  5. 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

Secondary outcomes

  1. Behavioral Activation (Patient Activation Measure)

    Time frame: 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.

  2. Subjective Health Status (PROMIS)

    Time frame: 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.

  3. Change in Weight in kg

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

    Change in weight in kg

  4. Change in Body Mass Index (BMI) in kg/m^2

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

    Change in body mass index (BMI) in kg/m^2

  5. Change in Waist Circumference in cm

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

    Change in waist circumference in cm

  6. Steps

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

    Fitibit will assess steps

  7. Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) -

    Time frame: 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.

  8. Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week

    Time frame: 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.

  9. Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 7, 2017
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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