Trial Outcomes & Findings for OA Clinic-Community CARE Model (NCT NCT05349500)
NCT ID: NCT05349500
Last Updated: 2025-01-14
Results Overview
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.
COMPLETED
NA
60 participants
Baseline, Month 6 (Follow-up)
2025-01-14
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OA Clinic-Community CARE Model
Baseline characteristics by cohort
| Measure |
OA CARE
n=30 Participants
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.
|
Usual Care
n=30 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 10.5 • n=99 Participants
|
65.6 years
STANDARD_DEVIATION 9.1 • n=107 Participants
|
64.4 years
STANDARD_DEVIATION 9.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
WOMAC Total Score
|
40.7 units on a scale
STANDARD_DEVIATION 14.4 • n=99 Participants
|
37.9 units on a scale
STANDARD_DEVIATION 17.3 • n=107 Participants
|
39.3 units on a scale
STANDARD_DEVIATION 15.8 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6 (Follow-up)Population: Participants who completed both baseline and 6-month follow-up assessments
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.
Outcome measures
| Measure |
OA CARE
n=24 Participants
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.
|
Usual Care
n=27 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
|
-7.8 units on a scale
Interval -16.04 to 0.4
|
3.2 units on a scale
Interval -4.8 to 11.2
|
PRIMARY outcome
Timeframe: Baseline, Month 12 (Follow-up)Population: Participants who completed both baseline and 12-month follow-up assessment
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.
Outcome measures
| Measure |
OA CARE
n=23 Participants
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.
|
Usual Care
n=24 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
|
-8.3 units on a scale
Interval -16.4 to -0.2
|
-3.3 units on a scale
Interval -11.3 to 4.6
|
SECONDARY outcome
Timeframe: Baseline, Month 6 (Follow-up)Population: Participants who completed baseline and 6-month follow-up assessments
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.
Outcome measures
| Measure |
OA CARE
n=24 Participants
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.
|
Usual Care
n=27 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
|
-1.5 units on a scale
Interval -3.6 to 0.5
|
0.5 units on a scale
Interval -1.6 to 2.5
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Follow-up)Population: Participants who completed baseline and 12-month follow-up assessments
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.
Outcome measures
| Measure |
OA CARE
n=23 Participants
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.
|
Usual Care
n=24 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
|
-2.1 units on a scale
Interval -4.1 to 0.0
|
-0.4 units on a scale
Interval -2.5 to 1.6
|
SECONDARY outcome
Timeframe: Baseline, Month 6 (Follow-up)Population: Participants who completed baseline and 6-month follow-up assessments
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.
Outcome measures
| Measure |
OA CARE
n=24 Participants
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.
|
Usual Care
n=27 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
|
-4.9 units on a scale
Interval -10.6 to 0.7
|
2.6 units on a scale
Interval -2.8 to 8.0
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Follow-up)Population: Participants who completed baseline and 12-month follow-up assessments
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.
Outcome measures
| Measure |
OA CARE
n=23 Participants
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.
|
Usual Care
n=24 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
|
-4.5 units on a scale
Interval -10.1 to 1.0
|
-2.6 units on a scale
Interval -7.9 to 2.8
|
SECONDARY outcome
Timeframe: Baseline, Month 6 (Follow-up)Population: Participants who completed baseline and 6-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear.
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.
Outcome measures
| Measure |
OA CARE
n=22 Participants
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.
|
Usual Care
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 6 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed.
|
0.2 log (minutes / week)
Interval -0.2 to 0.5
|
-0.0 log (minutes / week)
Interval -0.3 to 0.3
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Follow-up)Population: Participants who completed baseline and 6-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear.
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.
Outcome measures
| Measure |
OA CARE
n=20 Participants
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.
|
Usual Care
n=20 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 12 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed
|
-0.3 log (minutes / week)
Interval -0.6 to 0.1
|
-0.1 log (minutes / week)
Interval -0.4 to 0.3
|
SECONDARY outcome
Timeframe: Baseline, Month 6 (Follow-up)Population: Participants who completed baseline and 6-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear.
Step counts measured via accelerometer. This measure was log transformed because raw data did not meet assumptoms for statsitical models.
Outcome measures
| Measure |
OA CARE
n=22 Participants
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.
|
Usual Care
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 6 in Steps Per Day, Log Transformed
|
0.00 log (steps / day)
Interval -0.2 to 0.3
|
-0.0 log (steps / day)
Interval -0.3 to 0.2
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Follow-up)Population: Participants who completed baseline and 12-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear.
Step counts measured via accelerometer. This measure was log transformed because raw data did not meet assumptoms for statsitical models.
Outcome measures
| Measure |
OA CARE
n=20 Participants
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.
|
Usual Care
n=20 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 12 in Steps Per Day, Log Transformed
|
-0.1 log (steps / day)
Interval -0.3 to 0.2
|
-0.1 log (steps / day)
Interval -0.4 to 0.1
|
SECONDARY outcome
Timeframe: Baseline, Month 6 (Follow-up)Population: Participants who completed both baseline and 6-month follow-up acceleromter assessments. Note that some participants completed questionnaires but not accelerometer wear.
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.
Outcome measures
| Measure |
OA CARE
n=22 Participants
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.
|
Usual Care
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) Per Day, Standardized to a 16 Hour Day
|
-0.0 minutes / day
Interval -0.1 to 0.1
|
0.0 minutes / day
Interval -0.1 to 0.1
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Follow-up)Population: Participants who completed both baseline and 12-month follow-up acceleromter assessments. Note that some participants completed questionnaires but not accelerometer wear.
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.
Outcome measures
| Measure |
OA CARE
n=20 Participants
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.
|
Usual Care
n=20 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 12 in Minutes of Any Physical Activity (PA) Per Day, Standardized to 16 Hour Day
|
-0.1 min/day
Interval -0.2 to 0.0
|
-0.1 min/day
Interval -0.2 to 0.1
|
SECONDARY outcome
Timeframe: Baseline, Month 6 (Follow-up)Population: Participants who completed baseline and 6-month questionnaires
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.
Outcome measures
| Measure |
OA CARE
n=24 Participants
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.
|
Usual Care
n=27 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 6 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed
|
4.6 square root (minutes per week)
Interval 2.3 to 6.9
|
1.2 square root (minutes per week)
Interval -0.9 to 3.3
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Follow-up)Population: Participants who completed baseline and 12-month questionnaires
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.
Outcome measures
| Measure |
OA CARE
n=23 Participants
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.
|
Usual Care
n=24 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 12 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed
|
4.3 square root (minutes per week)
Interval 1.3 to 7.3
|
2.2 square root (minutes per week)
Interval -0.7 to 5.1
|
SECONDARY outcome
Timeframe: Baseline, Month 6 (Follow-up)Population: Participants who completed baseline and 6-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear.
Sedentary minutes measured via accelerometer This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time.
Outcome measures
| Measure |
OA CARE
n=22 Participants
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.
|
Usual Care
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 6 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day
|
10.5 minutes / day
Interval -15.1 to 36.1
|
-2.9 minutes / day
Interval -26.4 to 20.6
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Follow-up)Population: Participants who completed baseline and 12-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear.
Sedentary minutes measured via accelerometer This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time.
Outcome measures
| Measure |
OA CARE
n=20 Participants
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.
|
Usual Care
n=20 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 12 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day
|
18.6 minutes / day
Interval -9.6 to 46.9
|
9.3 minutes / day
Interval -18.6 to 37.2
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Follow-up)Population: Participants who completed both baseline and 12-month follow-up weight assessment.
Body weight assessed using a research / clinical grade scale (e.g., Tanita) that will be calibrated regularly.
Outcome measures
| Measure |
OA CARE
n=23 Participants
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.
|
Usual Care
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 12 in Body Weight
|
-7.6 kg
Interval -15.5 to 0.4
|
-5.4 kg
Interval -13.0 to 2.3
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Follow-up)Population: Participants who completed both baseline and 12-month follow-up chair stand tests.
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.
Outcome measures
| Measure |
OA CARE
n=14 Participants
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.
|
Usual Care
n=21 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 12 in 30-second Chair Stand Test
|
-0.9 number of chair stands in 30 seconds
Interval -2.5 to 0.7
|
-0.6 number of chair stands in 30 seconds
Interval -1.8 to 0.7
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Follow-up)Population: Participants who completed both baseline and 12-month TUG tests.
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.
Outcome measures
| Measure |
OA CARE
n=15 Participants
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.
|
Usual Care
n=12 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 12 in Timed Up-and-go (TUG) Test
|
0.5 seconds
Interval -0.9 to 1.8
|
2.0 seconds
Interval 0.9 to 3.1
|
SECONDARY outcome
Timeframe: Baseline, Month 12 (Follow-up)Population: Participants who completed both baseline and 12-month follow-up 2-minute march tests.
Assessed to evaluate participant functional aerobic endurance. Measured by number of steps completed in 2 minutes.
Outcome measures
| Measure |
OA CARE
n=14 Participants
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.
|
Usual Care
n=21 Participants
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.
|
|---|---|---|
|
Change From Baseline to Month 12 in 2-minute March Test
|
29.7 steps
Interval 17.4 to 42.0
|
14.8 steps
Interval 4.9 to 24.7
|
Adverse Events
OA CARE
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kelli Allen, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place