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| ID | Type | Description | Link |
|---|---|---|---|
| K23AG051681 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Active Comparator | Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology. |
|
| MOWI Weight Loss Maintenance | Experimental | Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI. |
|
| Develop & Refine MOWI w Fitbit (2B) | Active Comparator | Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology. |
|
| Develop & Refine MOWI w Fitbit/Protein (2P) | Active Comparator | Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Develop & Refine MOWI w/o Amulet | Behavioral | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Food Craving Acceptance and Action Questionnaire Score |
Inclusion Criteria:
All Aims:
Aims 2 & 3:
Exclusion Criteria:
Aim 4 - had to have completed Aims 2 or 3
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| Name | Affiliation | Role |
|---|---|---|
| John A Batsis, MD | Dartmouth-Hitchcock Medical Center / Dartmouth Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33653394 | Derived | 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. |
| Label | URL |
|---|---|
| Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Qualitative Assessment | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | MOWI Weight Loss Maintenance | Evaluate the feasibility, acceptability, + potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI. 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 min. The overall structure 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. Participants in "MOWI Weight Loss Maintenance" were separately enrolled in this Study and did not enter the Maintenance from one or more remaining arms included here. |
| FG002 | 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. 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. |
| FG003 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Grip Strength | Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change. | For MOWI Weight Loss Maintenance, this was not a measure of evaluation | Posted | Mean | Standard Deviation | Kg | Baseline, 12 weeks |
|
3 months
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment | Temporal Artery biopsy (admission to hospital) for headache |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Systematic Assessment | Dyspnea, chest pain |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John A. Batsis, MD | Dartmouth-Hitchcock | 603-650-5000 | john.batsis@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 3, 2018 | May 23, 2019 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011506 | Proteins |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Two Arm Pilot Study
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|
|
| MOWI Weight Loss Maintenance | Behavioral | 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 | Behavioral | 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. |
|
|
| Develop & Refine MOWI w Fitbit/Protein | Dietary Supplement | 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. |
|
|
| 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 |
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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Amulet Technology Development \& Validation | View source |
| Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Home-Based Pilot | View source |
| BG001 | 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. 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). |
| BG002 | 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. 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. |
| BG003 | 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. 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. |
| OG002 | 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. 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. |
|
|
| Primary | Change in 5 Times Sit-to-Stand (STS) | STS measures lower limb strength (minimal change 2.3 s). | For MOWI Weight Loss Maintenance this was not evaluated | Posted | Mean | Standard Deviation | Seconds | 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 | For MOWI Weight Loss Maintenance this was not evaluated | Posted | Mean | Standard Deviation | Meters | 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). | For MOWI Weight Loss Maintenance this was not evaluated | Posted | Mean | Standard Deviation | 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. | For MOWI Weight Loss Maintenance this was not evaluated | Posted | Mean | Standard Deviation | Points | 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 | For MOWI Weight Loss Maintenance this was not evaluated | Posted | Mean | Standard Deviation | Points | 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 | For MOWI Weight Loss Maintenance this was not evaluated | Posted | Mean | Standard Deviation | Points | Baseline, 12-weeks |
|
|
|
| Secondary | Change in Weight in kg | Change in weight in kg | Posted | Mean | Standard Deviation | Kg | Baseline, 12 weeks |
|
|
|
| Secondary | Change in Waist Circumference in cm | Change in waist and hip circumference in cm | For MOWI Weight Loss Maintenance this was not evaluated | Posted | Mean | Standard Deviation | Cm | Baseline, 12 weeks post study |
|
|
|
| Secondary | Average Steps/Expenditure | Average Steps will be measured over a 12 week period | For MOWI Weight Loss Maintenance this was not evaluated. For Aim 2A, no fitness device was provided to participants and hence cannot evaluate this outcome in that arm | Posted | Mean | Standard Deviation | Steps | 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 - | Posted | Mean | Standard Deviation | activities per week | Change Score between baseline and 12 weeks |
|
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| 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 | For MOWI Weight Loss Maintenance this was not evaluated. In 2A (Develop & Refine MOWI w/o Amulet was not measured. This technique was not available for MOWI 2A participants and hence not measured | Posted | Mean | Standard Deviation | Kg | Baseline, 12 weeks |
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| Secondary | Change in Energy Expenditure | Resting metabolic rate, Change Score (kCal) from Baseline to 12 weeks | Posted | Mean | Standard Deviation | kCal | Baseline to 12 weeks |
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| Secondary | Change in Fasting Plasma Glucose | Fasting Plasma Glucose | Posted | Mean | Standard Deviation | mg/mL | Baseline, 12 weeks |
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| 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. | only measured in maintenance arm | Posted | Mean | Standard Deviation | score on a scale | 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)) |
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| 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 | only measured in this intervention | Posted | Mean | Standard Deviation | score on a scale | Baseline (of maintenance intervention) and 6 months (into maintenance) - pre/post |
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| 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 - | Posted | Mean | Standard Deviation | activities per week | Change Score between baseline and 12 weeks |
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| 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 - | Posted | Mean | Standard Deviation | hours | Change Score between baseline and 12 weeks |
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| 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 - | Posted | Mean | Standard Deviation | kCal | Change in KCal between baseline and 12 weeks |
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| Other Pre-specified | 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 | Posted | Number | percentage of total sessions | Baseline, 12 weeks post study |
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| Other Pre-specified | 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. | only measured in this arm | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Other Pre-specified | 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. | only measured in this arm | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Other Pre-specified | 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. | only measured in this arm | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Other Pre-specified | 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. | assessed only in this arm | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Other Pre-specified | 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. | only assessed in this arm | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Other Pre-specified | 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. | only assessed in this arm | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Other Pre-specified | 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. | Only assessed in this arm | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Other Pre-specified | 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. | only assessed in this arm | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Other Pre-specified | 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. | only assessed in this arm | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Secondary | Change in Insulin Level | insulin | Posted | Mean | Standard Deviation | mIU/L | Baseline, 12 weeks |
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| Secondary | Change in C-peptide | C-peptide | Posted | Mean | Standard Deviation | ng/mL | Baseline, 12 weeks |
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| Secondary | Change in C-reactive Protein | C-reactive protein | Posted | Mean | Standard Deviation | mg/L | Baseline, 12 weeks |
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| Secondary | Change in Tumor Necrosis Factor Alpha | tumor necrosis factor alpha | Posted | Mean | Standard Deviation | pg/mL | Baseline, 12 weeks |
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| Secondary | Change in Interleukin 6 | Interleukin 6 | Posted | Mean | Standard Deviation | pg/mL | Baseline, 12 weeks |
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| 0 |
| 9 |
| 1 |
| 9 |
| 4 |
| 9 |
| EG001 | 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. 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). | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | 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. 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. | 0 | 14 | 3 | 14 | 12 | 14 |
| EG003 | 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. 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. | 0 | 14 | 1 | 14 | 5 | 14 |
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| Chest pain | Cardiac disorders | Systematic Assessment | Chest Pain |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment | Knee, Hip, neck, shoulder discomofort or any type that impacts joints/muscles |
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| Neurological | Nervous system disorders | Systematic Assessment | Headache, TIA, vertigo |
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| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment | Bloating, diverticulitis |
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| Constitutional | General disorders | Systematic Assessment | fatigue, not feeling well |
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| Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Chest cold |
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Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| Moderate intensity activity duration |
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| Title | Measurements |
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| Identified regulation subscale |
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| Integrated regulation subscale |
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| Intrisic motivation subscale |
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