Trial Outcomes & Findings for Development of a Mind Body Program for Obese Knee Osteoarthritis Patients With Comorbid Depression (NCT NCT04334278)
NCT ID: NCT04334278
Last Updated: 2024-06-28
Results Overview
Number of patients that attend a minimum of 4 of 6 weekly sessions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
6-weeks
Results posted on
2024-06-28
Participant Flow
A total of 66 patients were enrolled. However, 15 participants were excluded prior to randomization/group assignment because they were lost to follow-up when scheduling baseline testing.
Participant milestones
| Measure |
GetHealthy-OA
The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity. The GetHealthy-OA will be delivered by secure telehealth.
GetHealthy-OA: The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity. The GetHealthy-OA will be delivered by secure telehealth.
|
Health Enhancement Program
The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis. It is an 6-week group mind body program that will be delivered via secure telehealth. To control for in between session practice, participants will receive an mp3 recording and informational handout to complete after each session.
Health Enhancement Program: The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis. It is an 6-week group mind body program that will be delivered via secure telehealth.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
23
|
|
Overall Study
COMPLETED
|
24
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
GetHealthy-OA
The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity. The GetHealthy-OA will be delivered by secure telehealth.
GetHealthy-OA: The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity. The GetHealthy-OA will be delivered by secure telehealth.
|
Health Enhancement Program
The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis. It is an 6-week group mind body program that will be delivered via secure telehealth. To control for in between session practice, participants will receive an mp3 recording and informational handout to complete after each session.
Health Enhancement Program: The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis. It is an 6-week group mind body program that will be delivered via secure telehealth.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
Baseline Characteristics
Development of a Mind Body Program for Obese Knee Osteoarthritis Patients With Comorbid Depression
Baseline characteristics by cohort
| Measure |
GetHealthy-OA
n=28 Participants
The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity. The GetHealthy-OA will be delivered by secure telehealth.
GetHealthy-OA: The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity. The GetHealthy-OA will be delivered by secure telehealth.
|
Health Enhancement Program
n=23 Participants
The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis. It is an 6-week group mind body program that will be delivered via secure telehealth. To control for in between session practice, participants will receive an mp3 recording and informational handout to complete after each session.
Health Enhancement Program: The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis. It is an 6-week group mind body program that will be delivered via secure telehealth.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 6 • n=5 Participants
|
56 years
STANDARD_DEVIATION 8 • n=7 Participants
|
55 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
23 participants
n=7 Participants
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-weeksNumber of patients that attend a minimum of 4 of 6 weekly sessions
Outcome measures
| Measure |
GetHealthy-OA
n=28 Participants
The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity. The GetHealthy-OA will be delivered by secure telehealth.
GetHealthy-OA: The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity. The GetHealthy-OA will be delivered by secure telehealth.
|
Health Enhancement Program
n=23 Participants
The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis. It is an 6-week group mind body program that will be delivered via secure telehealth. To control for in between session practice, participants will receive an mp3 recording and informational handout to complete after each session.
Health Enhancement Program: The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis. It is an 6-week group mind body program that will be delivered via secure telehealth.
|
|---|---|---|
|
Treatment Adherence
|
24 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksNumber of days participants wore the Accelerometers at least 8 hours per day
Outcome measures
| Measure |
GetHealthy-OA
n=28 Participants
The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity. The GetHealthy-OA will be delivered by secure telehealth.
GetHealthy-OA: The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity. The GetHealthy-OA will be delivered by secure telehealth.
|
Health Enhancement Program
n=23 Participants
The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis. It is an 6-week group mind body program that will be delivered via secure telehealth. To control for in between session practice, participants will receive an mp3 recording and informational handout to complete after each session.
Health Enhancement Program: The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis. It is an 6-week group mind body program that will be delivered via secure telehealth.
|
|---|---|---|
|
Accelerometer Compliance
Baseline
|
6 days
Interval 0.0 to 7.0
|
6 days
Interval 1.0 to 7.0
|
|
Accelerometer Compliance
6-weeks
|
3 days
Interval 0.0 to 7.0
|
4 days
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksNumber of missing blood or urine specimens per patient
Outcome measures
| Measure |
GetHealthy-OA
n=56 Specimens
The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity. The GetHealthy-OA will be delivered by secure telehealth.
GetHealthy-OA: The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity. The GetHealthy-OA will be delivered by secure telehealth.
|
Health Enhancement Program
n=46 Specimens
The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis. It is an 6-week group mind body program that will be delivered via secure telehealth. To control for in between session practice, participants will receive an mp3 recording and informational handout to complete after each session.
Health Enhancement Program: The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis. It is an 6-week group mind body program that will be delivered via secure telehealth.
|
|---|---|---|
|
Number of Missing Specimens
6-weeks - blood
|
7 Specimens
|
6 Specimens
|
|
Number of Missing Specimens
Baseline - blood
|
1 Specimens
|
0 Specimens
|
|
Number of Missing Specimens
Baseline - urine
|
6 Specimens
|
5 Specimens
|
|
Number of Missing Specimens
6-weeks - urine
|
12 Specimens
|
17 Specimens
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: As part of the intervention the GetHealthy-OA group was the only group to have homework. The Health Enhancement Program didn't have any recorded homework, which is why there is daily practice adherence listed for the Health Enhancement Program.
Number of patients that completed daily practice at least 4 days per week
Outcome measures
| Measure |
GetHealthy-OA
n=28 Participants
The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity. The GetHealthy-OA will be delivered by secure telehealth.
GetHealthy-OA: The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity. The GetHealthy-OA will be delivered by secure telehealth.
|
Health Enhancement Program
The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis. It is an 6-week group mind body program that will be delivered via secure telehealth. To control for in between session practice, participants will receive an mp3 recording and informational handout to complete after each session.
Health Enhancement Program: The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis. It is an 6-week group mind body program that will be delivered via secure telehealth.
|
|---|---|---|
|
Daily Practice Adherence
|
18 Participants
|
—
|
Adverse Events
GetHealthy-OA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Enhancement Program
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place