MOWI Research Pilot

• ClinicalTrials.gov Identifier: NCT03104192
• Recruitment Status: Completed
• First Posted: April 7, 2017
• Results First Posted: July 1, 2020
• Last Update Posted: November 9, 2021
• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): John A. Batsis, MD, Dartmouth-Hitchcock Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity	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	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 69 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Two Arm Pilot Study
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot
• Actual Study Start Date: September 1, 2017
• Actual Primary Completion Date: January 3, 2019
• Actual Study Completion Date: January 11, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Develop & Refine MOWI w/o Amulet (2A); 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; 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.; Other Name: MOWI 2A
Experimental: 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.	Behavioral: MOWI Weight Loss Maintenance; 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).; Other Name: MOWI LT
Active Comparator: Develop & Refine MOWI w Fitbit (2B); 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; 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.; Other Name: MOWI 2B-2
Active Comparator: Develop & Refine MOWI w Fitbit/Protein (2P); 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; 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.; Other Name: MOWI Protein-2

Outcome Measures

Primary Outcome Measures :

1. Change in Grip Strength [ Time Frame: Baseline, 12 weeks ]
   Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.
2. Change in 5 Times Sit-to-Stand (STS) [ Time Frame: Baseline, 12 weeks ]
   STS measures lower limb strength (minimal change 2.3 s).
3. Change in Six-Minute Walk Test (6MWT) [ Time Frame: Baseline, 12 weeks ]
   A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m
4. Change in Gait Speed (m/s) [ Time Frame: 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).
5. Change in Late-Life Function and Disability Instrument (LLFDI) [ Time Frame: 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 :

1. Change in Behavioral Activation (Patient Activation Measure) [ Time Frame: 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
2. Change in Subjective Health Status (PROMIS) Physical [ Time Frame: 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
3. Change in Weight in kg [ Time Frame: Baseline, 12 weeks ]
   Change in weight in kg
4. Change in Waist Circumference in cm [ Time Frame: Baseline, 12 weeks post study ]
   Change in waist and hip circumference in cm
5. Average Steps/Expenditure [ Time Frame: Mean steps over 12 week period of time ]
   Average Steps will be measured over a 12 week period
6. Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) [ Time Frame: Baseline, 12 weeks post study ]
   CHAMPS is a self-reported tool in older adults that assesses activity levels and types
7. Change in Body Composition - Lean Mass [ Time Frame: 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
8. Energy Expenditure [ Time Frame: Baseline, 12 weeks ]
   Resting metabolic rate
9. Biomarkers [ Time Frame: Baseline, 12 weeks ]
   Inflammatory cytokines, bone turnover, energy metabolism, homeostasis
10. Change in Participant Satisfaction Questionnaire Score [ Time Frame: 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.
11. Change in Credibility and Expectancy Questionnaire Score [ Time Frame: 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

Other Outcome Measures:

1. Compliance to Whey Protein Consumption as Measured by Percent of the Total Number of Sessions Whey Could Have Been Taken [ Time Frame: Baseline, 12 weeks post study ]
   Medication adherence, visual analog scale
2. Change in Food Craving Acceptance and Action Questionnaire Score [ Time Frame: 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 Food Craving Acceptance and Action Questionnaire is a 10-item questionnaire which measures acceptance of food related cravings and urges using a Likert scale (1-7 point scale: never true = 1 to always true = 7). Total scores range 10-70: higher scores indicate greater acceptance of food related cravings and urges.
3. Change in Discomfort Intolerance Scale Score [ Time Frame: 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 Discomfort intolerance Scale is a 6-item questionnaire which measures general difficulty managing and regulating physical distress and discomfort using a Likert scale (1-6 point scale: not at all like me = 1 to very much like me = 6). Total scores range 6-36: higher scores indicate greater distress intolerance.
4. Change in Physical Activity Acceptance & Action Questionnaire Score [ Time Frame: 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 Physical Activity Acceptance & Action Questionnaire is a 10-item scale which measures acceptance of physical and psychological discomfort in the context of physical activity using a Likert scale (1-7 point scale: never true = 1 to always true = 7). Total scores range 10-70: higher scores indicate greater acceptance of physical and psychological discomfort in the context of physical activity.
5. Change in Weight Control Strategies Scale Score [ Time Frame: 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 Weight Control Strategies Scale is a 30-item questionnaire which measures participants' use of behavioral weight control strategies using a Likert scale (1-4 point scale: never = 0 to always = 4). Total scores range 0-120: higher scores indicate greater use of weight control strategies.
6. Change in Voluntary Exercise Questionnaire Score [ Time Frame: 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 Voluntary Exercise Questionnaire is a brief 6-item questionnaire which measures participants' participation in aerobic and strength training activities over the past 3 months and past week. Two items use a Likert scale (1-7 point scale: never = 1 to 7 = very often) and four items ask participants to report frequency of exercise: 0 = 0 days per week to 7 = 7 days per week). Total score range 2-42: Higher scores indicate greater levels of aerobic and strength training activity.
7. Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) Score [ Time Frame: 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) ]
   a 24-item assessment of external, introjected, identified, and intrinsic forms of regulation of exercise behavior. Higher scores indicated higher exercise behavior. each is scored on 5 points (0-120). Six subscales - each 4 items (score 0-20 each). A positive change score indicates higher forms of regulation.
8. Change in PROMIS Emotional Distress Short Form Score [ Time Frame: 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) ]
   an 8 item scale used to measure emotional distress/depression. higher score indicates higher distress. All promis questionnaires raw scores are converted to a scaled score of 0-100. 50 is mean. 10 units on the scale indicate 1 Standard deviation. higher change scores represent reduced emotional distress.
9. Change in PROMIS Social Isolation Short Form Score [ Time Frame: 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) ]
   An 8-item scale used to measure perceived social isolation.higher scores indicate higher isolation. All promis questionnaires raw scores are converted to a scaled score of 0-100. 50 is mean. 10 units on the scale indicate 1 Standard deviation. higher change scores represent high isolation.
10. Change in Three Factor Eating Questionnaire Score [ Time Frame: 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) ]

    18-item scale measuring eating behavior with 3 subscales (cognitive restraint, emotional eating, uncontrolled eating) using Likert scale (1-4 point scale). Items 1-16 on this scale are reverse scored. The scale score is then entered into the following formula: (cognitive restraint scale score - 3)/9. The outcome is then multiplied by 100. Higher scores indicate higher restraint, emotional eating or uncontrolled eating, respectively. Subscales aretransformed to 0-100 score

    To calculate the emotional eating sub scale, reverse scored items 2, 4, 7, 10, 14 and 16 are summed and then averaged to generate a mean score. The mean score is then multiplied by 6 to generate a scale score. The scale score is then entered into the following formula: (emotional eating scale score - 6)/18. The outcome is then multiplied by 100.

    Positive change scores represent lower restraint, higher emotional eating or higher uncontrolled eating.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, New Hampshire

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03766

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

National Institute on Aging (NIA)

Investigators

• Principal Investigator: John A Batsis, MD; Dartmouth-Hitchcock Medical Center / Dartmouth Medical School

  Study Documents (Full-Text)

Documents provided by John A. Batsis, MD, Dartmouth-Hitchcock Medical Center:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] July 3, 2018

More Information

Additional Information:

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

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

Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Home-Based Pilot 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: John A. Batsis, MD, Associate Professor, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT03104192
• Other Study ID Numbers: D16182_2; K23AG051681 ( U.S. NIH Grant/Contract )
• First Posted: April 7, 2017
• Results First Posted: July 1, 2020
• Last Update Posted: November 9, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John A. Batsis, MD, Dartmouth-Hitchcock Medical Center:

frail elderly; telemedicine; obesity; rural health; health promotion; weight loss

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight