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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
69
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.
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).
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Change in Grip Strength
Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.
Time frame: Baseline, 12 weeks
Change in 5 Times Sit-to-Stand (STS)
STS measures lower limb strength (minimal change 2.3 s).
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: Baseline, 12 weeks
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
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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.
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.
Time frame: 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
Time frame: Baseline, 12-weeks
Change in Weight in kg
Change in weight in kg
Time frame: Baseline, 12 weeks
Change in Waist Circumference in cm
Change in waist and hip circumference in cm
Time frame: Baseline, 12 weeks post study
Average Steps/Expenditure
Average Steps will be measured over a 12 week period
Time frame: 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 -
Time frame: 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
Time frame: Baseline, 12 weeks
Change in Energy Expenditure
Resting metabolic rate, Change Score (kCal) from Baseline to 12 weeks
Time frame: Baseline to 12 weeks
Change in Fasting Plasma Glucose
Fasting Plasma Glucose
Time frame: 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.
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))
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
Time frame: 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 -
Time frame: 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 -
Time frame: 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 -
Time frame: Change in KCal between baseline and 12 weeks
Change in Insulin Level
insulin
Time frame: Baseline, 12 weeks
Change in C-peptide
C-peptide
Time frame: Baseline, 12 weeks
Change in C-reactive Protein
C-reactive protein
Time frame: Baseline, 12 weeks
Change in Tumor Necrosis Factor Alpha
tumor necrosis factor alpha
Time frame: Baseline, 12 weeks
Change in Interleukin 6
Interleukin 6
Time frame: Baseline, 12 weeks