MOWI Research Pilot

Study Overview
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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 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

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

Conditions
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Obesity

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Two Arm Pilot Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Develop & Refine MOWI w/o Amulet (2A)<br>Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology. | Behavioral: Develop & Refine MOWI w/o Amulet<br>* The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.<br>* Other names: MOWI 2A;|
| Experimental: MOWI Weight Loss Maintenance<br>Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI. | Behavioral: MOWI Weight Loss Maintenance<br>* Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).<br>* Other names: MOWI LT;|
| Active Comparator: Develop & Refine MOWI w Fitbit (2B)<br>Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology. | Behavioral: Develop & Refine MOWI w Fitbit<br>* The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.<br>* Other names: MOWI 2B-2;|
| Active Comparator: Develop & Refine MOWI w Fitbit/Protein (2P)<br>Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein. | Dietary Supplement: Develop & Refine MOWI w Fitbit/Protein<br>* The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.<br>* Other names: MOWI Protein-2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Grip Strength | Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change. | Baseline, 12 weeks | 
| Change in 5 Times Sit-to-Stand (STS) | STS measures lower limb strength (minimal change 2.3 s). | Baseline, 12 weeks | 
| 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 | Baseline, 12 weeks | 
| Change in Gait Speed (m/s) | 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). | Baseline, 12 weeks | 
| 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. 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. | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 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. 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 | Baseline, 12 weeks post study | 
| Change in Subjective Health Status (PROMIS) Physical | 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 | Baseline, 12-weeks | 
| Change in Weight in kg | Change in weight in kg | Baseline, 12 weeks | 
| Change in Waist Circumference in cm | Change in waist and hip circumference in cm | Baseline, 12 weeks post study | 
| Average Steps/Expenditure | Average Steps will be measured over a 12 week period | Mean steps over 12 week period of time | 
| Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Activities | CHAMPS is a self-reported tool in older adults that assesses activity levels and types - | Change Score between baseline and 12 weeks | 
| Change in Body Composition - Lean Mass | Lean mass was assessed using bioelectrical impedance for 2P and 2B. This technique was not available for MOWI 2A participants and hence not measured | Baseline, 12 weeks | 
| Change in Energy Expenditure | Resting metabolic rate, Change Score (kCal) from Baseline to 12 weeks | Baseline to 12 weeks | 
| Change in Fasting Plasma Glucose | Fasting Plasma Glucose | Baseline, 12 weeks | 
| Change in Participant Satisfaction Questionnaire Score | 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 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)) | 
| Change in Credibility and Expectancy Questionnaire Score | 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 | Baseline (of maintenance intervention) and 6 months (into maintenance) - pre/post | 
| Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Not Exercising Activities | CHAMPS is a self-reported tool in older adults that assesses activity levels and types - | Change Score between baseline and 12 weeks | 
| Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration | CHAMPS is a self-reported tool in older adults that assesses activity levels and types - | Change Score between baseline and 12 weeks | 
| 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 - | Change in KCal between baseline and 12 weeks | 
| Change in Insulin Level | insulin | Baseline, 12 weeks | 
| Change in C-peptide | C-peptide | Baseline, 12 weeks | 
| Change in C-reactive Protein | C-reactive protein | Baseline, 12 weeks | 
| Change in Tumor Necrosis Factor Alpha | tumor necrosis factor alpha | Baseline, 12 weeks | 
| Change in Interleukin 6 | Interleukin 6 | Baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frail elderly, telemedicine, obesity, rural health, health promotion, weight loss