MOWI Research Pilot

Not Applicable

Completed

Conditions: Obesity

Interventions: Dietary Supplement: Develop & Refine MOWI w Fitbit/Protein
Behavioral: Develop & Refine MOWI w Fitbit
Behavioral: Develop & Refine MOWI w/o Amulet
Behavioral: MOWI Weight Loss Maintenance

Registration Number: NCT03104192

Lead Sponsor: Dartmouth-Hitchcock Medical Center

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 69

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Develop & Refine MOWI w Fitbit/Protein (2P)	Develop & Refine MOWI w Fitbit/Protein	Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.
Develop & Refine MOWI w Fitbit (2B)	Develop & Refine MOWI w Fitbit	Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.
Develop & Refine MOWI w/o Amulet (2A)	Develop & Refine MOWI w/o Amulet	Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.
MOWI Weight Loss Maintenance	MOWI Weight Loss Maintenance	Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.

Primary Outcome Measures

Name	Time	Method
Change in Grip Strength	Baseline, 12 weeks	Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.
Change in Six-Minute Walk Test (6MWT)	Baseline, 12 weeks	A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m
Change in Gait Speed (m/s)	Baseline, 12 weeks	Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (significant change 0.1 m/s).
Change in 5 Times Sit-to-Stand (STS)	Baseline, 12 weeks	STS measures lower limb strength (minimal change 2.3 s).
Change in Late-Life Function and Disability Instrument (LLFDI)	Baseline, 12 weeks	LLFDI consists of a 32-item function and 16-item disability (life-task) scales that correlate with gait speed and lower limb function. Higher points indicate better function. Individual raw scores range from 0 to 80, scaled scores are 0 to 100. Each was assessed at baseline and at 12 weeks. We report the differences between baseline/follow-up. Positive score change reflect improved physical function.

Secondary Outcome Measures

Name	Time	Method
Change in C-peptide	Baseline, 12 weeks	C-peptide
Change in Interleukin 6	Baseline, 12 weeks	Interleukin 6
Change in Behavioral Activation (Patient Activation Measure)	Baseline, 12 weeks post study	Patient Activation Measure (PAM) assesses knowledge, confidence and skill for managing health and grouped into 4 levels revealing insights into attitudes, motivators, behaviors \& outcomes. Higher points indicate better activation. Measures are scored 0-100 units. Scores below reflect changes between baseline and follow-up at 12-weeks. A positive change score indicates improvement in activation
Change in Energy Expenditure	Baseline to 12 weeks	Resting metabolic rate, Change Score (kCal) from Baseline to 12 weeks
Change in Participant Satisfaction Questionnaire Score	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))	The Participant Satisfaction Questionnaire is a 12-item questionnaire which measures participant satisfaction with intervention participation using a Likert scale (0-5 point scale: very unsatisfied = 0 to very satisfied = 4). Total scores range 0-60: higher scores indicate greater satisfaction with the intervention.Three additional sub-items ask participants to rate their preference for the frequency of sessions, length of group meetings, and total number of group meetings using a Likert scale (-1 - 1 point scale: too few/too short = -1 to 1 = too much/too long). Each of these three items will be interpreted individually and not included in a summed total score. Additionally, this questionnaire includes 1 open-ended response item where participants are asked to leave any additional comments they may have regarding their level of satisfaction with the intervention.
Change in Insulin Level	Baseline, 12 weeks	insulin
Change in Waist Circumference in cm	Baseline, 12 weeks post study	Change in waist and hip circumference in cm
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Activities	Change Score between baseline and 12 weeks	CHAMPS is a self-reported tool in older adults that assesses activity levels and types -
Change in Credibility and Expectancy Questionnaire Score	Baseline (of maintenance intervention) and 6 months (into maintenance) - pre/post	The Credibility and Expectancy Questionnaire is a 6-item questionnaire which measures expectancies regarding intervention participation and intervention rationale credibility using a Likert scale (0-10 point scale: responses are anchored to question stems such that, not at all logical/not at all effective/not at all confident/no credibility/not at all comfortable = 0 and very logical/very effective/very confident/high credibility = 10). Total scores range 0-50: higher scores indicate more favorable expectancies regarding participation in the intervention/greater perceived intervention credibility. Additionally, this questionnaire includes 1 open-ended response item that asks participants to leave any additional comments they may have regarding their expectations for the intervention
Change in Subjective Health Status (PROMIS) Physical	Baseline, 12-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. Higher points indicate better health. Raw scores are scaled to 0-100. 50 is the mean, 10 points indicates 1 standard deviation. Positive change scores listed below indicate an improvement in subjective health
Change in Weight in kg	Baseline, 12 weeks	Change in weight in kg
Average Steps/Expenditure	Mean steps over 12 week period of time	Average Steps will be measured over a 12 week period
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Not Exercising Activities	Change Score between baseline and 12 weeks	CHAMPS is a self-reported tool in older adults that assesses activity levels and types -
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS)	Change in KCal between baseline and 12 weeks	CHAMPS is a self-reported tool in older adults that assesses activity levels and types -
Change in C-reactive Protein	Baseline, 12 weeks	C-reactive protein
Change in Tumor Necrosis Factor Alpha	Baseline, 12 weeks	tumor necrosis factor alpha
Change in Body Composition - Lean Mass	Baseline, 12 weeks	Lean mass was assessed using bioelectrical impedance for 2P and 2B. This technique was not available for MOWI 2A participants and hence not measured
Change in Fasting Plasma Glucose	Baseline, 12 weeks	Fasting Plasma Glucose
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration	Change Score between baseline and 12 weeks	CHAMPS is a self-reported tool in older adults that assesses activity levels and types -