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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AR080309-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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The purpose of this study is to test the OA Clinic-Community CARE Model (OA CARE) which will address all recommended components of knee/hip (osteoarthritis) OA care, include interventions for both patients and primary care providers (PCPs), and utilize a tailored approach that efficiently matches treatments with patients' needs.
The patient component of OA CARE will include evidence-based weight management and exercise programs for all participants (delivered through the YMCA), as well as tailored referrals to physical therapy, additional weight management or nutrition services, sleep-related services and psychological services.
The PCP component of OA CARE will include a video-based summary of current OA treatment guidelines (with emphasis on practical application), collaboration on patients' referrals to specific services described above, and progress reports on enrolled patients.
This study will be a randomized pilot trial of OA CARE among n=60 patients with knee and/or hip osteoarthritis (OA) and overweight/obesity who are not currently meeting physical activity recommendations. Participants will be randomly assigned to OA CARE or a usual care (UC) group. Assessments will be conducted at baseline, 6 months and 12 months. Primary endpoint of the trial will be self-reported pain and function and secondary endpoint will be objectively assessed physical activity (PA), measured via accelerometer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OA CARE | Experimental | Participants assigned to the OA CARE intervention will receive a 12-month Medical Membership to a local YMCA and participate in a 12-week weight loss program. Participants will also work with an OA CARE Navigator, who, in partnership with their primary care provider (PCP), will identify any additional programs or resources that may help them manage their osteoarthritis (OA) symptoms. |
|
| Usual Care | Placebo Comparator | Participants assigned to this group will receive no additional treatment from the study for about 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OA CARE Intervention | Behavioral | Once assigned, participants will be contacted by the OA CARE Navigator to coordinate initiating a YMCA Medical Membership. Then, YMCA personnel will contact the participant to schedule the first Weight Loss Program (Program) group session. The Program will be delivered in groups with other OA CARE participants. Participants will also have access to all exercise facilities and programs at the YMCA during the study, and will be assigned a YMCA health coach. After initiation of the YMCA Medical Membership, the OA CARE Navigator will discuss participant's interests in referrals to other services related to osteoarthritis (OA) management. The Navigator will provide the participant's primary care provider (PCP) with a summary of this discussion and help the participant connect to any programs or resources that do not require provider referrals. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score | For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations. | Baseline, Month 6 (Follow-up) |
| Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score | For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations. | Baseline, Month 12 (Follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | The WOMAC Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no pain) to 4 (extreme pain), with a total range of 0-20 with higher scores indicating worse symptoms and function. | Baseline, Month 6 (Follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelli D Allen, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Thurston Arthritis Research Center | Chapel Hill | North Carolina | 27599 | United States |
Deidentified individual data that supports the results will be shared following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/ sharing agreement with University of North Carolina at Chapel Hill (UNC).
Data will become available following publication of primary and secondary outcomes. Research study records will be maintained for no less than 6 years following the completion of the study.
Data will be accessible following publication of study results and will be available for no less than 6 years following the completion of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | OA CARE | Participants assigned to the OA CARE intervention will receive a 12-month Medical Membership to a local YMCA and participate in a 12-week weight loss program. Participants will also work with an OA CARE Navigator, who, in partnership with their primary care provider (PCP), will identify any additional programs or resources that may help them manage their osteoarthritis (OA) symptoms. OA CARE Intervention: Once assigned, participants will be contacted by the OA CARE Navigator to coordinate initiating a YMCA Medical Membership. Then, YMCA personnel will contact the participant to schedule the first Weight Loss Program (Program) group session. The Program will be delivered in groups with other OA CARE participants. Participants will also have access to all exercise facilities and programs at the YMCA during the study, and will be assigned a YMCA health coach. After initiation of the YMCA Medical Membership, the OA CARE Navigator will discuss participant's interests in referrals to other services related to osteoarthritis (OA) management. The Navigator will provide the participant's primary care provider (PCP) with a summary of this discussion and help the participant connect to any programs or resources that do not require provider referrals. |
| FG001 | Usual Care | Participants assigned to this group will receive no additional treatment from the study for about 12 months. Usual Care control group: Participants assigned to the usual care group will receive no additional treatment from the study for about 12 months. However, this group will be offered a 12-month Medical Membership to a local YMCA after completing the final assessment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OA CARE | Participants assigned to the OA CARE intervention will receive a 12-month Medical Membership to a local YMCA and participate in a 12-week weight loss program. Participants will also work with an OA CARE Navigator, who, in partnership with their primary care provider (PCP), will identify any additional programs or resources that may help them manage their osteoarthritis (OA) symptoms. OA CARE Intervention: Once assigned, participants will be contacted by the OA CARE Navigator to coordinate initiating a YMCA Medical Membership. Then, YMCA personnel will contact the participant to schedule the first Weight Loss Program (Program) group session. The Program will be delivered in groups with other OA CARE participants. Participants will also have access to all exercise facilities and programs at the YMCA during the study, and will be assigned a YMCA health coach. After initiation of the YMCA Medical Membership, the OA CARE Navigator will discuss participant's interests in referrals to other services related to osteoarthritis (OA) management. The Navigator will provide the participant's primary care provider (PCP) with a summary of this discussion and help the participant connect to any programs or resources that do not require provider referrals. |
| 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 From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score | For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations. | Participants who completed both baseline and 6-month follow-up assessments | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Month 6 (Follow-up) |
|
12 months
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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 | OA CARE | Participants assigned to the OA CARE intervention will receive a 12-month Medical Membership to a local YMCA and participate in a 12-week weight loss program. Participants will also work with an OA CARE Navigator, who, in partnership with their primary care provider (PCP), will identify any additional programs or resources that may help them manage their osteoarthritis (OA) symptoms. OA CARE Intervention: Once assigned, participants will be contacted by the OA CARE Navigator to coordinate initiating a YMCA Medical Membership. Then, YMCA personnel will contact the participant to schedule the first Weight Loss Program (Program) group session. The Program will be delivered in groups with other OA CARE participants. Participants will also have access to all exercise facilities and programs at the YMCA during the study, and will be assigned a YMCA health coach. After initiation of the YMCA Medical Membership, the OA CARE Navigator will discuss participant's interests in referrals to other services related to osteoarthritis (OA) management. The Navigator will provide the participant's primary care provider (PCP) with a summary of this discussion and help the participant connect to any programs or resources that do not require provider referrals. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelli Allen, PhD | University of North Carolina at Chapel Hill | 919-966-0558 | kdallen@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2024 | Dec 5, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 28, 2022 | Feb 28, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| D050177 | Overweight |
| D009765 | Obesity |
| D057185 | Sedentary Behavior |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Usual Care control group | Behavioral | Participants assigned to the usual care group will receive no additional treatment from the study for about 12 months. However, this group will be offered a 12-month Medical Membership to a local YMCA after completing the final assessment. |
|
| Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | The WOMAC Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no pain) to 4 (extreme pain), with a total range of 0-20 with higher scores indicating worse symptoms and function. | Baseline, Month 12 (Follow-up) |
| Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | The WOMAC function subscale includes 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty), with ranges of 0-68 for the function subscale with higher scores indicating worse symptoms and function. | Baseline, Month 6 (Follow-up) |
| Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | The WOMAC function subscale includes 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty), with ranges of 0-68 for the function subscale with higher scores indicating worse symptoms and function. | Baseline, Month 12 (Follow-up) |
| Change From Baseline to Month 6 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed. | Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer. This measure was log transformed because raw data did not meet assumptoms for statsitical models. | Baseline, Month 6 (Follow-up) |
| Change From Baseline to Month 12 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed | Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer. This measure was log transformed because raw data did not meet assumptoms for statsitical models. | Baseline, Month 12 (Follow-up) |
| Change From Baseline to Month 6 in Steps Per Day, Log Transformed | Step counts measured via accelerometer. This measure was log transformed because raw data did not meet assumptoms for statsitical models. | Baseline, Month 6 (Follow-up) |
| Change From Baseline to Month 12 in Steps Per Day, Log Transformed | Step counts measured via accelerometer. This measure was log transformed because raw data did not meet assumptoms for statsitical models. | Baseline, Month 12 (Follow-up) |
| Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) Per Day, Standardized to a 16 Hour Day | Minutes of any PA measured via accelerometer. This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time. | Baseline, Month 6 (Follow-up) |
| Change From Baseline to Month 12 in Minutes of Any Physical Activity (PA) Per Day, Standardized to 16 Hour Day | Minutes of any PA measured via accelerometer. This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time. | Baseline, Month 12 (Follow-up) |
| Change From Baseline to Month 6 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed | Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. Separate scores are derived for physical activities of moderate or greater intensity (metabolic equivalents MET ≥ 3.0) and for all activities listed (light, moderate, and vigorous). Estimates of frequency (days per week) range from 0 to 7 days per week. Estimates of Variety (# different activities), while open, generally ranges from 0 to 5, values above 5 are checked. Estimates of minutes, generally range from 0 to 180 per day. Individuals reporting more than 180 minutes per day are checked. For all physical activity outcomes higher values equal a greater amount of activity. This measure was square root transformed becuase raw failed to meet assumptions for statistical analyses. | Baseline, Month 6 (Follow-up) |
| Change From Baseline to Month 12 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed | Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. Separate scores are derived for physical activities of moderate or greater intensity (metabolic equivalents (MET) ≥ 3.0) and for all activities listed (light, moderate, and vigorous). Estimates of frequency (days per week) range from 0 to 7 days per week. Estimates of Variety (# different activities), while open, generally ranges from 0 to 5, values above 5 are checked. Estimates of minutes, generally range from 0 to 180 per day. Individuals reporting more than 180 minutes per day are checked. For all physical activity outcomes higher values equal a greater amount of activity. This measure was square root transformed because raw data did not meet assumptions for statistical models. | Baseline, Month 12 (Follow-up) |
| Change From Baseline to Month 6 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day | Sedentary minutes measured via accelerometer This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time. | Baseline, Month 6 (Follow-up) |
| Change From Baseline to Month 12 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day | Sedentary minutes measured via accelerometer This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time. | Baseline, Month 12 (Follow-up) |
| Change From Baseline to Month 12 in Body Weight | Body weight assessed using a research / clinical grade scale (e.g., Tanita) that will be calibrated regularly. | Baseline, Month 12 (Follow-up) |
| Change From Baseline to Month 12 in 30-second Chair Stand Test | Assessed to test participant leg strength and endurance. Measured by total number of chair stands (up and down equals one stand) completed in 30 seconds. | Baseline, Month 12 (Follow-up) |
| Change From Baseline to Month 12 in Timed Up-and-go (TUG) Test | Assessed to measure participant functional mobility. Measured by how many seconds it takes for participant to stand up, walk to the mark, turn around, return & sit back into a chair with their back resting on the back of the chair. | Baseline, Month 12 (Follow-up) |
| Change From Baseline to Month 12 in 2-minute March Test | Assessed to evaluate participant functional aerobic endurance. Measured by number of steps completed in 2 minutes. | Baseline, Month 12 (Follow-up) |
| BG001 | Usual Care | Participants assigned to this group will receive no additional treatment from the study for about 12 months. Usual Care control group: Participants assigned to the usual care group will receive no additional treatment from the study for about 12 months. However, this group will be offered a 12-month Medical Membership to a local YMCA after completing the final assessment. |
| BG002 | 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 |
|
| WOMAC Total Score | For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Usual Care | Participants assigned to this group will receive no additional treatment from the study for about 12 months. Usual Care control group: Participants assigned to the usual care group will receive no additional treatment from the study for about 12 months. However, this group will be offered a 12-month Medical Membership to a local YMCA after completing the final assessment. |
|
|
|
| Primary | Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score | For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations. | Participants who completed both baseline and 12-month follow-up assessment | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Month 12 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | The WOMAC Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no pain) to 4 (extreme pain), with a total range of 0-20 with higher scores indicating worse symptoms and function. | Participants who completed baseline and 6-month follow-up assessments | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Month 6 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | The WOMAC Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no pain) to 4 (extreme pain), with a total range of 0-20 with higher scores indicating worse symptoms and function. | Participants who completed baseline and 12-month follow-up assessments | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Month 12 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | The WOMAC function subscale includes 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty), with ranges of 0-68 for the function subscale with higher scores indicating worse symptoms and function. | Participants who completed baseline and 6-month follow-up assessments | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Month 6 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | The WOMAC function subscale includes 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty), with ranges of 0-68 for the function subscale with higher scores indicating worse symptoms and function. | Participants who completed baseline and 12-month follow-up assessments | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Month 12 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 6 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed. | Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer. This measure was log transformed because raw data did not meet assumptoms for statsitical models. | Participants who completed baseline and 6-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear. | Posted | Mean | 95% Confidence Interval | log (minutes / week) | Baseline, Month 6 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 12 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed | Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer. This measure was log transformed because raw data did not meet assumptoms for statsitical models. | Participants who completed baseline and 6-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear. | Posted | Mean | 95% Confidence Interval | log (minutes / week) | Baseline, Month 12 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 6 in Steps Per Day, Log Transformed | Step counts measured via accelerometer. This measure was log transformed because raw data did not meet assumptoms for statsitical models. | Participants who completed baseline and 6-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear. | Posted | Mean | 95% Confidence Interval | log (steps / day) | Baseline, Month 6 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 12 in Steps Per Day, Log Transformed | Step counts measured via accelerometer. This measure was log transformed because raw data did not meet assumptoms for statsitical models. | Participants who completed baseline and 12-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear. | Posted | Mean | 95% Confidence Interval | log (steps / day) | Baseline, Month 12 (Follow-up) |
|
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|
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| Secondary | Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) Per Day, Standardized to a 16 Hour Day | Minutes of any PA measured via accelerometer. This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time. | Participants who completed both baseline and 6-month follow-up acceleromter assessments. Note that some participants completed questionnaires but not accelerometer wear. | Posted | Mean | 95% Confidence Interval | minutes / day | Baseline, Month 6 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 12 in Minutes of Any Physical Activity (PA) Per Day, Standardized to 16 Hour Day | Minutes of any PA measured via accelerometer. This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time. | Participants who completed both baseline and 12-month follow-up acceleromter assessments. Note that some participants completed questionnaires but not accelerometer wear. | Posted | Mean | 95% Confidence Interval | min/day | Baseline, Month 12 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 6 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed | Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. Separate scores are derived for physical activities of moderate or greater intensity (metabolic equivalents MET ≥ 3.0) and for all activities listed (light, moderate, and vigorous). Estimates of frequency (days per week) range from 0 to 7 days per week. Estimates of Variety (# different activities), while open, generally ranges from 0 to 5, values above 5 are checked. Estimates of minutes, generally range from 0 to 180 per day. Individuals reporting more than 180 minutes per day are checked. For all physical activity outcomes higher values equal a greater amount of activity. This measure was square root transformed becuase raw failed to meet assumptions for statistical analyses. | Participants who completed baseline and 6-month questionnaires | Posted | Mean | 95% Confidence Interval | square root (minutes per week) | Baseline, Month 6 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 12 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed | Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. Separate scores are derived for physical activities of moderate or greater intensity (metabolic equivalents (MET) ≥ 3.0) and for all activities listed (light, moderate, and vigorous). Estimates of frequency (days per week) range from 0 to 7 days per week. Estimates of Variety (# different activities), while open, generally ranges from 0 to 5, values above 5 are checked. Estimates of minutes, generally range from 0 to 180 per day. Individuals reporting more than 180 minutes per day are checked. For all physical activity outcomes higher values equal a greater amount of activity. This measure was square root transformed because raw data did not meet assumptions for statistical models. | Participants who completed baseline and 12-month questionnaires | Posted | Mean | 95% Confidence Interval | square root (minutes per week) | Baseline, Month 12 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 6 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day | Sedentary minutes measured via accelerometer This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time. | Participants who completed baseline and 6-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear. | Posted | Mean | 95% Confidence Interval | minutes / day | Baseline, Month 6 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 12 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day | Sedentary minutes measured via accelerometer This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time. | Participants who completed baseline and 12-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear. | Posted | Mean | 95% Confidence Interval | minutes / day | Baseline, Month 12 (Follow-up) |
|
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|
|
| Secondary | Change From Baseline to Month 12 in Body Weight | Body weight assessed using a research / clinical grade scale (e.g., Tanita) that will be calibrated regularly. | Participants who completed both baseline and 12-month follow-up weight assessment. | Posted | Mean | 95% Confidence Interval | kg | Baseline, Month 12 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 12 in 30-second Chair Stand Test | Assessed to test participant leg strength and endurance. Measured by total number of chair stands (up and down equals one stand) completed in 30 seconds. | Participants who completed both baseline and 12-month follow-up chair stand tests. | Posted | Mean | 95% Confidence Interval | number of chair stands in 30 seconds | Baseline, Month 12 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 12 in Timed Up-and-go (TUG) Test | Assessed to measure participant functional mobility. Measured by how many seconds it takes for participant to stand up, walk to the mark, turn around, return & sit back into a chair with their back resting on the back of the chair. | Participants who completed both baseline and 12-month TUG tests. | Posted | Mean | 95% Confidence Interval | seconds | Baseline, Month 12 (Follow-up) |
|
|
|
|
| Secondary | Change From Baseline to Month 12 in 2-minute March Test | Assessed to evaluate participant functional aerobic endurance. Measured by number of steps completed in 2 minutes. | Participants who completed both baseline and 12-month follow-up 2-minute march tests. | Posted | Mean | 95% Confidence Interval | steps | Baseline, Month 12 (Follow-up) |
|
|
|
|
| 1 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Usual Care | Participants assigned to this group will receive no additional treatment from the study for about 12 months. Usual Care control group: Participants assigned to the usual care group will receive no additional treatment from the study for about 12 months. However, this group will be offered a 12-month Medical Membership to a local YMCA after completing the final assessment. | 0 | 30 | 0 | 30 | 0 | 30 |
Not provided
Not provided
| D012216 |
| Rheumatic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001836 | Body Weight Changes |