Obesity Clinical Trial
Official title:
Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot
Verified date | November 2022 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center | National Institute on Aging (NIA) |
United States,
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 |
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