Trial Outcomes & Findings for Weight Loss and Exercise for Communities With Arthritis in North Carolina (NCT NCT02577549)

Last Updated: 2023-06-27

Results Overview

To determine whether a pragmatic, community-based, 18-month diet-induced weight-loss and exercise intervention implemented in three North Carolina counties with diverse residential (from urban to rural) and socioeconomic composition significantly decreases knee pain \[as measured by the Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) pain subscale\] in overweight and obese adults with knee Osteoarthritis (OA) compared to an attention-control group - test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4) - Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations - The WOMAC measures five items for pain (score range 0-20). Measure Description: Range, 0 to 20 (0, no pain; 2 to 8, mild; \>8 to 14, moderate; and \>14 to 20, severe); between-group MCID = 1.6, calculated as half the SD.

Recruitment status

COMPLETED

Study phase

Target enrollment

823 participants

Primary outcome timeframe

18 months

Results posted on

2023-06-27

Participant Flow

We used overlapping recruitment strategies. A combination of mailings, local newspaper ads, and direct targeting through electronic health records were used. We also had strong ties with local aging service networks and access to senior centers, senior high-rise residential sites, churches, and a large database of older adults who signed consent to be contacted about participating in future clinical trials.

Participant milestones

Participant milestones
Measure	Diet & Exercise Participants attended an exercise class 3 days/week for 18 months. The exercise program consisted of a 15-minute aerobic phase, a 20-minute strength training phase, a second 15-minute aerobic phase, and a 10 minute cool down phase. Participant's also attended individual and group diet sessions. Each participant's minimum weight loss goal was 10% of baseline body weight.	Attention Control The attention control intervention covered an 18-month period delivered in five 1-hour, in-person group meetings at months 1, 3, 6, 9, and 15. Information was also provided in paper packets and in individual telephone sessions every other month.
Overall Study STARTED	414	409
Overall Study COMPLETED	336	332
Overall Study NOT COMPLETED	78	77

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Weight Loss and Exercise for Communities With Arthritis in North Carolina

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diet & Exercise n=414 Participants Participants attended an exercise class 3 days/week for 18 months. The exercise program consisted of a 15-minute aerobic phase, a 20-minute strength training phase, a second 15-minute aerobic phase, and a 10 minute cool down phase. Participant's also attended individual and group diet sessions. Each participant's minimum weight loss goal was 10% of baseline body weight. Diet \& Exercise: Participants attended exercise and diet classes.	Attention Control n=409 Participants The attention control intervention covered an 18-month period delivered in five 1-hour, in-person group meetings at months 1, 3, 6, 9, and 15. Information was also provided in paper packets and in individual telephone sessions every other month. Attention Control: Participants attended healthy living classes and received health newsletters and phone calls/emails/texts.	Total n=823 Participants Total of all reporting groups
Age, Continuous	64.5 years STANDARD_DEVIATION 7.8 • n=5 Participants	64.7 years STANDARD_DEVIATION 7.8 • n=7 Participants	64.6 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	320 Participants n=5 Participants	317 Participants n=7 Participants	637 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants	92 Participants n=7 Participants	186 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	407 Participants n=5 Participants	401 Participants n=7 Participants	808 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 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	111 Participants n=5 Participants	116 Participants n=7 Participants	227 Participants n=5 Participants
Race (NIH/OMB) White	289 Participants n=5 Participants	281 Participants n=7 Participants	570 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	10 Participants n=7 Participants	21 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
Womac pain score	7.5 score on a scale STANDARD_DEVIATION 3.2 • n=5 Participants	7.5 score on a scale STANDARD_DEVIATION 3.3 • n=7 Participants	7.5 score on a scale STANDARD_DEVIATION 3.2 • n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: A total of 13 persons (7 in D\&E and 6 in attention control) did not complete this testing measure but completed other measures.

Outcome measures

Outcome measures
Measure	Diet & Exercise n=329 Participants Participants attended an exercise class 3 days/week for 18 months. The exercise program consisted of a 15-minute aerobic phase, a 20-minute strength training phase, a second 15-minute aerobic phase, and a 10 minute cool down phase. Participant's also attended individual and group diet sessions. Each participant's minimum weight loss goal was 10% of baseline body weight. Diet \& Exercise: Participants attended exercise and diet classes.	Attention Control n=316 Participants The attention control intervention covered an 18-month period delivered in five 1-hour, in-person group meetings at months 1, 3, 6, 9, and 15. Information was also provided in paper packets and in individual telephone sessions every other month. Attention Control: Participants attended healthy living classes and received health newsletters and phone calls/emails/texts.
Knee Pain	5.0 score on a scale Interval 4.6 to 5.4	5.5 score on a scale Interval 5.1 to 5.9

SECONDARY outcome

Timeframe: 18 months

Population: Not all persons completing the study completed this measure at follow up.

To determine whether a pragmatic, community-based, 18-month, diet-induced weight-loss and exercise intervention improves WOMAC self-reported function in overweight and obese adults with knee OA compared to an attention control group - test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4) - Higher scores on the WOMAC indicate more pain, stiffness, and functional limitations. The WOMAC function score is a total of seventeen items for function (total score range 0-68). Measure Description: Range, 0 to 68 (0, no difficulty; 68, extreme).

Outcome measures

Outcome measures
Measure	Diet & Exercise n=325 Participants Participants attended an exercise class 3 days/week for 18 months. The exercise program consisted of a 15-minute aerobic phase, a 20-minute strength training phase, a second 15-minute aerobic phase, and a 10 minute cool down phase. Participant's also attended individual and group diet sessions. Each participant's minimum weight loss goal was 10% of baseline body weight. Diet \& Exercise: Participants attended exercise and diet classes.	Attention Control n=311 Participants The attention control intervention covered an 18-month period delivered in five 1-hour, in-person group meetings at months 1, 3, 6, 9, and 15. Information was also provided in paper packets and in individual telephone sessions every other month. Attention Control: Participants attended healthy living classes and received health newsletters and phone calls/emails/texts.
Function	16.5 score on a scale Interval 15.3 to 17.7	19.8 score on a scale Interval 18.6 to 21.0

SECONDARY outcome

Timeframe: 18 months

Population: Not all persons completing the study completed this measure at follow up.

To determine whether a pragmatic, community-based, 18-month, diet-induced weight-loss and exercise intervention improves health-related quality of life as measured by the physical subscale of the SF-36 questionnaire in overweight and obese adults with knee OA compared to an attention control group - Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state - The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

Outcome measures

Outcome measures
Measure	Diet & Exercise n=321 Participants Participants attended an exercise class 3 days/week for 18 months. The exercise program consisted of a 15-minute aerobic phase, a 20-minute strength training phase, a second 15-minute aerobic phase, and a 10 minute cool down phase. Participant's also attended individual and group diet sessions. Each participant's minimum weight loss goal was 10% of baseline body weight. Diet \& Exercise: Participants attended exercise and diet classes.	Attention Control n=306 Participants The attention control intervention covered an 18-month period delivered in five 1-hour, in-person group meetings at months 1, 3, 6, 9, and 15. Information was also provided in paper packets and in individual telephone sessions every other month. Attention Control: Participants attended healthy living classes and received health newsletters and phone calls/emails/texts.
Health Related Quality of Life (SF-36) Physical Subscale	41.4 score on a scale Interval 40.2 to 42.6	37.6 score on a scale Interval 36.3 to 38.8

SECONDARY outcome

Timeframe: 18 months

Population: Not all persons completing the study completed this measure at follow up.

To determine whether a pragmatic, community-based, 18-month, diet-induced weight-loss and exercise intervention improves 6-minute walk distance (an accepted measure of mobility) in overweight and obese adults with knee OA compared to an attention control group.

Outcome measures

Outcome measures
Measure	Diet & Exercise n=247 Participants Participants attended an exercise class 3 days/week for 18 months. The exercise program consisted of a 15-minute aerobic phase, a 20-minute strength training phase, a second 15-minute aerobic phase, and a 10 minute cool down phase. Participant's also attended individual and group diet sessions. Each participant's minimum weight loss goal was 10% of baseline body weight. Diet \& Exercise: Participants attended exercise and diet classes.	Attention Control n=219 Participants The attention control intervention covered an 18-month period delivered in five 1-hour, in-person group meetings at months 1, 3, 6, 9, and 15. Information was also provided in paper packets and in individual telephone sessions every other month. Attention Control: Participants attended healthy living classes and received health newsletters and phone calls/emails/texts.
Mobility (Six Minute Walk)	419 meters Interval 411.0 to 428.0	376 meters Interval 368.0 to 385.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Population: Currently only data for the primary outcome and some of the secondary outcomes have been analyzed and published. Additional analyses are being conducted. The cost effectiveness outcome measure will be available to report in the coming months.

To establish the cost-effectiveness of this pragmatic, community-based, multimodal diet-induced weight-loss and exercise program by conducting cost-effectiveness and budgetary impact analyses using data from the current trial in a validated computer-simulated model of knee OA.

Outcome measures

Outcome data not reported

Adverse Events

Diet & Exercise

Serious events: 67 serious events

Other events: 107 other events

Deaths: 0 deaths

Attention Control

Serious events: 96 serious events

Other events: 93 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Diet & Exercise n=414 participants at risk Participants attended an exercise class 3 days/week for 18 months. The exercise program consisted of a 15-minute aerobic phase, a 20-minute strength training phase, a second 15-minute aerobic phase, and a 10 minute cool down phase. Participant's also attended individual and group diet sessions. Each participant's minimum weight loss goal was 10% of baseline body weight. Diet \& Exercise: Participants attended exercise and diet classes.	Attention Control n=409 participants at risk The attention control intervention covered an 18-month period delivered in five 1-hour, in-person group meetings at months 1, 3, 6, 9, and 15. Information was also provided in paper packets and in individual telephone sessions every other month. Attention Control: Participants attended healthy living classes and received health newsletters and phone calls/emails/texts.
Injury, poisoning and procedural complications Fall	17.1% 71/414 • Number of events 85 • Adverse events were collected from after the participant was randomized until completion of the 18 month intervention.	9.0% 37/409 • Number of events 46 • Adverse events were collected from after the participant was randomized until completion of the 18 month intervention.
Surgical and medical procedures Knee Injection	8.7% 36/414 • Number of events 44 • Adverse events were collected from after the participant was randomized until completion of the 18 month intervention.	13.7% 56/409 • Number of events 75 • Adverse events were collected from after the participant was randomized until completion of the 18 month intervention.

Additional Information

Dr. Stephen Messier

Wake Forest University

Phone: 336-758-5849

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place