MOWI Research Pilot

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104192
• Other study ID #: D16182_2
• Secondary ID: K23AG051681
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: January 11, 2020

Study information

• Verified date: November 2022
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 11, 2020
• Est. primary completion date: January 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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).
• 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.

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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance to Whey Protein Consumption as Measured by Percent of the Total Number of Sessions Whey Could Have Been Taken	Medication adherence, visual analog scale	Baseline, 12 weeks post study
Other	Change in Food Craving Acceptance and Action Questionnaire Score	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.	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)
Other	Change in Discomfort Intolerance Scale Score	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.	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)
Other	Change in Physical Activity Acceptance & Action Questionnaire Score	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.	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)
Other	Change in Weight Control Strategies Scale Score	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.	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)
Other	Change in Voluntary Exercise Questionnaire Score	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.	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)
Other	Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) Score	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.	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)
Other	Change in PROMIS Emotional Distress Short Form Score	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.	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)
Other	Change in PROMIS Social Isolation Short Form Score	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.	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)
Other	Change in Three Factor Eating Questionnaire Score	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.	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)
Primary	Change in Grip Strength	Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.	Baseline, 12 weeks
Primary	Change in 5 Times Sit-to-Stand (STS)	STS measures lower limb strength (minimal change 2.3 s).	Baseline, 12 weeks
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Change in Weight in kg	Change in weight in kg	Baseline, 12 weeks
Secondary	Change in Waist Circumference in cm	Change in waist and hip circumference in cm	Baseline, 12 weeks post study
Secondary	Average Steps/Expenditure	Average Steps will be measured over a 12 week period	Mean steps over 12 week period of time
Secondary	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
Secondary	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
Secondary	Change in Energy Expenditure	Resting metabolic rate, Change Score (kCal) from Baseline to 12 weeks	Baseline to 12 weeks
Secondary	Change in Fasting Plasma Glucose	Fasting Plasma Glucose	Baseline, 12 weeks
Secondary	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))
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Insulin Level	insulin	Baseline, 12 weeks
Secondary	Change in C-peptide	C-peptide	Baseline, 12 weeks
Secondary	Change in C-reactive Protein	C-reactive protein	Baseline, 12 weeks
Secondary	Change in Tumor Necrosis Factor Alpha	tumor necrosis factor alpha	Baseline, 12 weeks
Secondary	Change in Interleukin 6	Interleukin 6	Baseline, 12 weeks

External Links

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