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ObesityNCT03104205

MOWI Home-Based Pilot

A study testing Evaluate home-based MOWI in people with Obesity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Evaluate home-based MOWI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited States
Study dates
1 Oct 2018to 31 Jul 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • Severe mental or life-threatening illness
  • Dementia
  • Substance use
  • History of bariatric surgery
  • Suicidal ideation
  • Unable to perform measures
Show all 10Show fewer
  • Reside in nursing home
  • No advanced co-morbidity
  • No exercise restrictions
  • Not involved in other research studies that may interfere with participation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

Other trials in United States

About this study

Official title: Mobile Health Obesity Wellness Intervention in Rural Older Adults (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.

Read the 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

Conditions
Obesity
Being tested
Evaluate home-based MOWI
Keywords
frail elderly, telemedicine, obesity, rural health, health promotion, weight loss
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluate home-based MOWIBehavioural

    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).

Study groups in NCT03104205
Study groupRoleWhat they receive
Evaluate home-based MOWIExperimentalConduct and assess the feasibility, acceptability, and potential effectiveness of home-based MOWI in improving physical function.
Receives: Behavioral: Evaluate home-based MOWI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Grip Strength

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

    Measured: Change between baseline and follow-up at 26-weeks

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

    STS measures lower limb strength - change represented as repetitions.

    Measured: Change between baseline and follow-up at 26-weeks

  3. 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

    Measured: Change between baseline and follow-up at 26-weeks

  4. 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).

    Measured: Change between baseline and follow-up at 26-weeks

  5. 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

    Measured: Change between baseline and follow-up at 26-weeks

Secondary outcomes (9)

  1. Behavioral Activation (Patient Activation Measure)

    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.

    Measured: baseline and follow-up at 26-weeks

  2. Subjective Health Status (PROMIS)

    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.

    Measured: Change between baseline and follow-up at 26-weeks

  3. Change in Weight in kg

    Change in weight in kg

    Measured: Change between baseline and follow-up at 26-weeks

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

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

    Measured: Change between baseline and follow-up at 26-weeks

  5. Change in Waist Circumference in cm

    Change in waist circumference in cm

    Measured: Change between baseline and follow-up at 26-weeks

  6. Steps

    Fitibit will assess steps

    Measured: Change between baseline and follow-up at 26-weeks

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

    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.

    Measured: Change between baseline and follow-up at 26-weeks

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

    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.

    Measured: Change between baseline and follow-up at 26-weeks

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

    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.

    Measured: Change between baseline and follow-up at 26-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2017
  2. Study start1 Oct 2018
  3. Primary completion1 Jul 2020
  4. Study completion31 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
A single arm pilot intervention
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03104205
Sponsor's protocol ID
D16182_3
Other IDs
K23AG051681
Status last verified
Jun 2023
First submitted
3 Apr 2017
Last updated
12 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33435877

Questions about this trial

What is this clinical trial studying?

A study testing Evaluate home-based MOWI in people with Obesity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Grip Strength (time frame: Change between baseline and follow-up at 26-weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03104205, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.

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