Obesity
Conditions
Keywords
frail elderly, telemedicine, obesity, rural health, health promotion, weight loss
Brief summary
The goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology-assisted wellness intervention for older adults with obesity.
Detailed description
The national epidemic of obesity is also affecting older adults, and is associated with an increased risk of disability, nursing home placement and early mortality. Conventional weight loss programs have the potential to reduce body fat, but are difficult to access for older obese adults due to transportation and mobility challenges. The overarching goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology assisted wellness intervention for older adults with obesity. Study Timeline: September 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
Interventions
BEHAVIORALEvaluate 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).
Sponsors
National Institute on Aging (NIA)
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
A single arm pilot intervention
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥65 years * Body Mass Index (BMI) ≥ 30kg/m\^2 OR Waist circumference ≥88cm in females or ≥102cm in males * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Grip Strength | Change between baseline and follow-up at 26-weeks | Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change. |
| Change in 30 Second Sit-to-Stand (STS) | Change between baseline and follow-up at 26-weeks | STS measures lower limb strength - change represented as repetitions. |
| Change in Six-Minute Walk Test (6MWT) | Change between baseline and follow-up at 26-weeks | A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m |
| Change in Gait Speed (Meters Per Second) | Change between baseline and follow-up at 26-weeks | 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 in Late-Life Function and Disability Instrument (LLFDI) | Change between baseline and follow-up at 26-weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Steps | Change between baseline and follow-up at 26-weeks | Fitibit will assess steps |
| Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - | Change between baseline and follow-up at 26-weeks | 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. |
| Behavioral Activation (Patient Activation Measure) | baseline and follow-up at 26-weeks | 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. |
| Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week | Change between baseline and follow-up at 26-weeks | 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. |
| Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week | Change between baseline and follow-up at 26-weeks | 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. |
| Subjective Health Status (PROMIS) | Change between baseline and follow-up at 26-weeks | 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 in Weight in kg | Change between baseline and follow-up at 26-weeks | Change in weight in kg |
| Change in Body Mass Index (BMI) in kg/m^2 | Change between baseline and follow-up at 26-weeks | Change in body mass index (BMI) in kg/m\^2 |
| Change in Waist Circumference in cm | Change between baseline and follow-up at 26-weeks | Change in waist circumference in cm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 53 |
| Total | 53 |
Baseline characteristics
| Characteristic | Evaluate Home-based MOWI |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 53 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 72.9 years STANDARD_DEVIATION 3.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 53 Participants |
| Region of Enrollment United States | 53 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 14 / 53 |
| serious Total, serious adverse events | 1 / 53 |
Outcome results
Primary
Change in 30 Second Sit-to-Stand (STS)
STS measures lower limb strength - change represented as repetitions.
Time frame: Change between baseline and follow-up at 26-weeks
Population: Evaluating those completing the intervention n=44
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOWI Group | Change in 30 Second Sit-to-Stand (STS) | 3.1 repetitions | Standard Deviation 4.2 |
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).
Time frame: Change between baseline and follow-up at 26-weeks
Population: Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOWI Group | Change in Gait Speed (Meters Per Second) | -0.34 meters per second | Standard Deviation 0.14 |
Primary
Change in Grip Strength
Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.
Time frame: Change between baseline and follow-up at 26-weeks
Population: Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOWI Group | Change in Grip Strength | 1.2 kg | Standard Deviation 7 |
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
Time frame: Change between baseline and follow-up at 26-weeks
Population: Evaluating those completing the intervention n=44
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOWI Group | Change in Late-Life Function and Disability Instrument (LLFDI) | 3.4 units on a scale | Standard Deviation 4.7 |
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
Time frame: Change between baseline and follow-up at 26-weeks
Population: Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOWI Group | Change in Six-Minute Walk Test (6MWT) | 42.0 meters | Standard Deviation 77.3 |
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.
Time frame: baseline and follow-up at 26-weeks
Population: Subjective data is analyzed baseline and follow-up of participants n=53
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOWI Group | Behavioral Activation (Patient Activation Measure) | Baseline | 69.4 score on a scale | Standard Deviation 12.1 |
| MOWI Group | Behavioral Activation (Patient Activation Measure) | 26-weeks | 77.0 score on a scale | Standard Deviation 14.6 |
Secondary
Change in Body Mass Index (BMI) in kg/m^2
Change in body mass index (BMI) in kg/m\^2
Time frame: Change between baseline and follow-up at 26-weeks
Population: Evaluating those completing the intervention n=44
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOWI Group | Change in Body Mass Index (BMI) in kg/m^2 | -1.8 kg/m^2 | Standard Deviation 1.4 |
Secondary
Change in Waist Circumference in cm
Change in waist circumference in cm
Time frame: Change between baseline and follow-up at 26-weeks
Population: Evaluating those completing the intervention n=33. N=11 did not complete the follow-up evaluation as a result of COVID-19 restrictions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOWI Group | Change in Waist Circumference in cm | -2.6 cm | Standard Deviation 5.4 |
Secondary
Change in Weight in kg
Change in weight in kg
Time frame: Change between baseline and follow-up at 26-weeks
Population: Evaluating those completing the intervention n=44
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOWI Group | Change in Weight in kg | -4.6 kg | Standard Deviation 3.5 |
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.
Time frame: Change between baseline and follow-up at 26-weeks
Population: These are the completers of the intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOWI Group | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - | low intensity caloric expenditure per week (ckal/week) | 312.69 Kcal/week | Standard Deviation 1323.67 |
| MOWI Group | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - | moderate intensity caloric expenditure (Kcal/wk) | 5.05 Kcal/week | Standard Deviation 10.54 |
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.
Time frame: Change between baseline and follow-up at 26-weeks
Population: These are the completers of the intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOWI Group | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week | Not Exercising Frequency (frequency per week) | -2.93 exercise frequency per week | Standard Deviation 15.06 |
| MOWI Group | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week | Low intensity frequency (frequency per week) | 2.36 exercise frequency per week | Standard Deviation 7.9 |
| MOWI Group | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week | moderate intensity frequency (frequency per week) | 2.68 exercise frequency per week | Standard Deviation 5.3 |
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.
Time frame: Change between baseline and follow-up at 26-weeks
Population: These are the completers of the intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOWI Group | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week | Not exercise duration (hours per week) | -0.23 exercise hours per week | Standard Deviation 11.16 |
| MOWI Group | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week | low intensity duration (hours/week) | 1.64 exercise hours per week | Standard Deviation 5.35 |
| MOWI Group | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week | moderate intensity duration (hours per week) | 1.65 exercise hours per week | Standard Deviation 4.45 |
Secondary
Steps
Fitibit will assess steps
Time frame: Change between baseline and follow-up at 26-weeks
Population: Evaluating those completing the intervention n=44
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOWI Group | Steps | 4078 steps | Standard Deviation 3819 |
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.
Time frame: Change between baseline and follow-up at 26-weeks
Population: these are completers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOWI Group | Subjective Health Status (PROMIS) | Physical Function | 3.63 Change in the T score on a scale | Standard Deviation 4.89 |
| MOWI Group | Subjective Health Status (PROMIS) | Mental Function | 2.65 Change in the T score on a scale | Standard Deviation 5.7 |