Clinical trial NCT03104192: MOWI Research Pilot
Official title: Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research 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: 69
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Two Arm Pilot Study
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 2017 to June 2018:

Goal: Conduct a pilot study of improving weight and physical function in older adults with obesity. An mHealth Obesity Wellness Intervention (MOWI) will integrate Amulet +/- Fitbi with a weekly individual dietician-led nutritional session, along with twice weekly physical therapist led group exercise session.

Participation Duration: Three times weekly for 3 months

Eligibility criteria: Inclusion Criteria:

All Aims:

* Age ≥65 years
* Body Mass Index (BMI) ≥ 30kg/m\^2
* Waist circumference ≥88cm in females or ≥102cm in males

Aims 2 \& 3:

* 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

Aim 4 - had to have completed Aims 2 or 3

Primary outcomes:
measure: Change in Grip Strength
timeFrame: Baseline, 12 weeks
measure: Change in 5 Times Sit-to-Stand (STS)
timeFrame: Baseline, 12 weeks
measure: Change in Six-Minute Walk Test (6MWT)
timeFrame: Baseline, 12 weeks
measure: Change in Gait Speed (m/s)
timeFrame: Baseline, 12 weeks
measure: Change in Late-Life Function and Disability Instrument (LLFDI)
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in Behavioral Activation (Patient Activation Measure)
timeFrame: Baseline, 12 weeks post study
measure: Change in Subjective Health Status (PROMIS) Physical
timeFrame: Baseline, 12-weeks
measure: Change in Weight in kg
timeFrame: Baseline, 12 weeks
measure: Change in Waist Circumference in cm
timeFrame: Baseline, 12 weeks post study
measure: Average Steps/Expenditure
timeFrame: Mean steps over 12 week period of time
measure: Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Activities
timeFrame: Change Score between baseline and 12 weeks
measure: Change in Body Composition - Lean Mass
timeFrame: Baseline, 12 weeks
measure: Change in Energy Expenditure
timeFrame: Baseline to 12 weeks
measure: Change in Fasting Plasma Glucose
timeFrame: Baseline, 12 weeks
measure: Change in Participant Satisfaction Questionnaire Score
timeFrame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI))
measure: Change in Credibility and Expectancy Questionnaire Score
timeFrame: Baseline (of maintenance intervention) and 6 months (into maintenance) - pre/post
measure: Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Not Exercising Activities
timeFrame: Change Score between baseline and 12 weeks
measure: Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration
timeFrame: Change Score between baseline and 12 weeks
measure: Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS)
timeFrame: Change in KCal between baseline and 12 weeks
measure: Change in Insulin Level
timeFrame: Baseline, 12 weeks
measure: Change in C-peptide
timeFrame: Baseline, 12 weeks
measure: Change in C-reactive Protein
timeFrame: Baseline, 12 weeks
measure: Change in Tumor Necrosis Factor Alpha
timeFrame: Baseline, 12 weeks
measure: Change in Interleukin 6
timeFrame: Baseline, 12 weeks
Other outcomes:
measure: Compliance to Whey Protein Consumption as Measured by Percent of the Total Number of Sessions Whey Could Have Been Taken
timeFrame: Baseline, 12 weeks post study
measure: Change in Food Craving Acceptance and Action Questionnaire Score
timeFrame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
measure: Change in Discomfort Intolerance Scale Score
timeFrame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
measure: Change in Physical Activity Acceptance & Action Questionnaire Score
timeFrame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
measure: Change in Weight Control Strategies Scale Score
timeFrame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
measure: Change in Voluntary Exercise Questionnaire Score
timeFrame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
measure: Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) Score
timeFrame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
measure: Change in PROMIS Emotional Distress Short Form Score
timeFrame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
measure: Change in PROMIS Social Isolation Short Form Score
timeFrame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
measure: Change in Three Factor Eating Questionnaire Score
timeFrame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
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: Petersen CL, Christensen BC, Batsis JA. Weight management intervention identifies association of decreased DNA methylation age with improved functional age measures in older adults with obesity. Clin Epigenetics. 2021 Mar 2;13(1):46. doi: 10.1186/s13148-021-01031-7.