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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Baseline, Month 6 (Follow-up)

Results posted on

2025-01-14

Participant Flow

Participant milestones

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 919-966-0558

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place