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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 2018 to April 2021:
Goal: Conduct a study of improving weight and physical function in older adults with obesity at home using video-conferencing. An mHealth obesity wellness intervention (MOWI) will integrate a fitness device with a weekly individual dietician-led nutritional session, along with twice weekly physical therapist led group exercise session performed in a person's home.
Participation Duration: Three times weekly for 6 months. We shall also have participants return to the center once monthly
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluate home-based MOWI | Experimental | Conduct and assess the feasibility, acceptability, and potential effectiveness of home-based MOWI in improving physical function. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluate home-based MOWI | Behavioral | MOWI will be delivered via video-conferencing in the subject's home in a 3x per week, 26-week program from the coordinating center. It will include an individual dietician-led weekly nutrition session; 2x/week physical therapist-led group exercise session; and remote fitness device monitoring. We plan 5 cohorts of 8 subjects (n=40). In-person Research Assistant-led assessments will occur at 0, 8, 16 and 26 weeks. Recruitment, screening, selection criteria, and usability parallel Aim 2 (NCT03104192). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Grip Strength | Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change. | Change between baseline and follow-up at 26-weeks |
| Change in 30 Second Sit-to-Stand (STS) | STS measures lower limb strength - change represented as repetitions. | Change between baseline and follow-up at 26-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 | Change between baseline and follow-up at 26-weeks |
| Change in Gait Speed (Meters Per Second) | Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (a significant change is considered 0.1 meters per second). | Change between baseline and follow-up at 26-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. For this instrument we use only the 32-item function and scores are scaled. Minimum 0, Maximum 100. Higher scores indicate higher levels of function | Change between baseline and follow-up at 26-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. Score ranges from 0 to 100, higher scores indicate higher activation. | baseline and follow-up at 26-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|
| 33435877 | Derived | Batsis JA, Petersen CL, Clark MM, Cook SB, Kotz D, Gooding TL, Roderka MN, Al-Nimr RI, Pidgeon D, Haedrich A, Wright KC, Aquila C, Mackenzie TA. Feasibility and acceptability of a technology-based, rural weight management intervention in older adults with obesity. BMC Geriatr. 2021 Jan 12;21(1):44. doi: 10.1186/s12877-020-01978-x. |
| Label | URL |
|---|---|
| Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Amulet Technology Development \& Validation | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | MOWI Group | Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Evaluate Home-based MOWI | Conduct and assess the feasibility, acceptability, and potential effectiveness of home-based MOWI in improving physical function. Evaluate home-based MOWI: MOWI will be delivered via video-conferencing in the subject's home in a 3x per week, 26-week program from the coordinating center. It will include an individual dietician-led weekly nutrition session; 2x/week physical therapist-led group exercise session; and remote fitness device monitoring. We plan 5 cohorts of 8 subjects (n=40). In-person Research Assistant-led assessments will occur at 0, 8, 16 and 26 weeks. Recruitment, screening, selection criteria, and usability parallel Aim 2 (NCT03104192). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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. | Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions. | Posted | Mean | Standard Deviation | kg | Change between baseline and follow-up at 26-weeks |
|
|
6 months - duration of the intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MOWI Group | Single arm study that includes the cohort. There was one arm in this study of older adults with obesity that fulfilled criteria |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment | emergency room visit for atrial fibrillatino |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Shoulder, Knee, Kneck |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John A. Batsis | Dartmouth-Hitchcock | 6036505000 | john.a.batsis@hitchcock.org |
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| 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 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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A single arm pilot intervention
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|
| Subjective Health Status (PROMIS) | 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. A score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate better health. | Change between baseline and follow-up at 26-weeks |
| Change in Weight in kg | Change in weight in kg | Change between baseline and follow-up at 26-weeks |
| Change in Body Mass Index (BMI) in kg/m^2 | Change in body mass index (BMI) in kg/m^2 | Change between baseline and follow-up at 26-weeks |
| Change in Waist Circumference in cm | Change in waist circumference in cm | Change between baseline and follow-up at 26-weeks |
| Steps | Fitibit will assess steps | Change between baseline and follow-up at 26-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. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week. | Change between baseline and follow-up at 26-weeks |
| Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week | CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week. | Change between baseline and follow-up at 26-weeks |
| Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week | CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week. | Change between baseline and follow-up at 26-weeks |
| Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Qualitative Assessment | View source |
| Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot | View source |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
|
|
| Primary | Change in 30 Second Sit-to-Stand (STS) | STS measures lower limb strength - change represented as repetitions. | Evaluating those completing the intervention n=44 | Posted | Mean | Standard Deviation | repetitions | Change between baseline and follow-up at 26-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 | Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions. | Posted | Mean | Standard Deviation | meters | Change between baseline and follow-up at 26-weeks |
|
|
|
| Primary | Change in Gait Speed (Meters Per Second) | Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (a significant change is considered 0.1 meters per second). | Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions. | Posted | Mean | Standard Deviation | meters per second | Change between baseline and follow-up at 26-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. For this instrument we use only the 32-item function and scores are scaled. Minimum 0, Maximum 100. Higher scores indicate higher levels of function | Evaluating those completing the intervention n=44 | Posted | Mean | Standard Deviation | units on a scale | Change between baseline and follow-up at 26-weeks |
|
|
|
| Secondary | 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. Score ranges from 0 to 100, higher scores indicate higher activation. | Subjective data is analyzed baseline and follow-up of participants n=53 | Posted | Mean | Standard Deviation | score on a scale | baseline and follow-up at 26-weeks |
|
|
|
| Secondary | Subjective Health Status (PROMIS) | 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. A score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate better health. | these are completers | Posted | Mean | Standard Deviation | Change in the T score on a scale | Change between baseline and follow-up at 26-weeks |
|
|
|
| Secondary | Change in Weight in kg | Change in weight in kg | Evaluating those completing the intervention n=44 | Posted | Mean | Standard Deviation | kg | Change between baseline and follow-up at 26-weeks |
|
|
|
| Secondary | Change in Body Mass Index (BMI) in kg/m^2 | Change in body mass index (BMI) in kg/m^2 | Evaluating those completing the intervention n=44 | Posted | Mean | Standard Deviation | kg/m^2 | Change between baseline and follow-up at 26-weeks |
|
|
|
| Secondary | Change in Waist Circumference in cm | Change in waist circumference in cm | Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions. | Posted | Mean | Standard Deviation | cm | Change between baseline and follow-up at 26-weeks |
|
|
|
| Secondary | Steps | Fitibit will assess steps | Evaluating those completing the intervention n=44 | Posted | Mean | Standard Deviation | steps | Change between baseline and follow-up at 26-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. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week. | These are the completers of the intervention | Posted | Mean | Standard Deviation | Kcal/week | Change between baseline and follow-up at 26-weeks |
|
|
|
| Secondary | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week | CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week. | These are the completers of the intervention | Posted | Mean | Standard Deviation | exercise frequency per week | Change between baseline and follow-up at 26-weeks |
|
|
|
| Secondary | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week | CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week. | These are the completers of the intervention | Posted | Mean | Standard Deviation | exercise hours per week | Change between baseline and follow-up at 26-weeks |
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| 0 |
| 53 |
| 1 |
| 53 |
| 14 |
| 53 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
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