MOWI Home-Based Pilot

NCT ID: NCT03104205

Last Updated: 2023-06-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-07-31

Brief Summary

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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

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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

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A single arm pilot intervention
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Evaluate home-based MOWI

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

Group Type EXPERIMENTAL

Evaluate home-based MOWI

Intervention Type 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).

Interventions

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Evaluate home-based MOWI

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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John A. Batsis, MD

Associate Professor of Medicine and of The Dartmouth Institute Geisel School of Medicine at Dartmouth

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John A Batsis, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center / Dartmouth Medical School

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33435877 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

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https://clinicaltrials.gov/show/NCT03085589

Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Amulet Technology Development \& Validation

https://clinicaltrials.gov/ct2/show/NCT03041831

Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Qualitative Assessment

https://clinicaltrials.gov/show/NCT03104192

Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot

Other Identifiers

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K23AG051681

Identifier Type: NIH

Identifier Source: secondary_id

View Link

D16182_3

Identifier Type: -

Identifier Source: org_study_id

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