Weight Loss and Exercise for Communities With Arthritis i... | NCT02577549

ID	Type	Description	Link
U01AR068658	U.S. NIH Grant/Contract		View source

Weight Loss and Exercise for Communities With Arthritis i... | NCT02577549 | Trialant

Sponsor/Collaborators Module

Name	Class
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NIH

Description Module

Detailed Description

Obesity is a modifiable risk factor for knee osteoarthritis (OA), and weight loss is an effective non-pharmacologic treatment to reduce pain. Recently, the investigators determined that under ideal, highly controlled circumstances, a diet-induced weight loss of 10% combined with exercise was significantly better at reducing pain than either intervention alone. Compared to the investigators previous longterm weight loss and exercise trials of knee OA, the diet-induced weight loss and exercise group was twice as effective at relieving pain. Whether the investigators results can be generalized to less rigorously monitored patient cohorts is unknown. Thus the challenge the investigators now face is to provide the practical means to implement this proven treatment in the community setting. This study aims to develop and demonstrate the effectiveness of a systematic, practical, cost-effective diet-induced weight loss and exercise intervention in both urban and rural communities that can reduce pain and improve other clinical outcomes in knee OA patients. This pragmatic community-based trial will determine if the investigators previous findings translate to real-world settings and will address common concerns about barriers to effectiveness/ implementation.

Participants will be 820 ambulatory, community-dwelling, overweight and obese men and women who meet the American College of Rheumatology clinical criteria for knee OA. The primary aim is 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 in overweight and obese adults with knee OA relative to an attention control group. Secondary aims will determine whether this intervention improves self-reported function, health-related quality of life, and mobility. The investigators will also 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.

Many physicians who treat people with knee OA have no practical means to implement weight loss and exercise treatments. This study is significant in that it will test the effectiveness of a long-awaited and much needed community-based program that will serve as a blueprint for clinicians and public health officials in both urban and rural communities to implement a weight loss and exercise program designed to reduce knee pain and improve other clinical outcomes in overweight and obese people with knee OA that can be sustained long-term and at a reasonable cost.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diet & Exercise	Experimental	Participants will attend an exercise class 3 days/week for 18 months. The exercise program will consist 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 will also attend individual and group diet sessions. Each participant's minimum weight loss goal will be 10% of baseline body weight.	Behavioral: Diet & Exercise
Attention Control	Active Comparator	The attention control intervention will cover an 18-month period. There will be five total face to face group meetings over the 18 months, with one meeting each at months 1, 3, 6, 9, and 15; and during the other months (months 2-5, 7-11, 13-17) participants will receive a combination of informational packets, webinars, phone sessions, and/or emails based on continued monitoring of participant needs and delivered via their preferred mode of contact.	Behavioral: Attention Control

Name	Type	Description	Arm Group Labels	Other Names
Diet & Exercise	Behavioral	Participants will attend exercise and diet classes.	Diet & Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knee Pain	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.	18 months

Secondary Outcomes

Measure	Description	Time Frame
Function	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).

Other Outcomes

Measure	Description	Time Frame
Cost-effectiveness	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.	18 months

Contacts/Locations Module

Name	Affiliation	Role
Stephen P Messier, PhD	Wake Forest University	Principal Investigator
Leigh Callahan, PhD	University of North Carolina, Chapel Hill	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Johnston County - UNC Chapel Hill		Chapel Hill	North Carolina	27516	United States
Haywood County - Haywood Regional Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28228115	Background	Messier SP, Callahan LF, Beavers DP, Queen K, Mihalko SL, Miller GD, Losina E, Katz JN, Loeser RF, Quandt SA, DeVita P, Hunter DJ, Lyles MF, Newman J, Hackney B, Jordan JM. Weight-loss and exercise for communities with arthritis in North Carolina (we-can): design and rationale of a pragmatic, assessor-blinded, randomized controlled trial. BMC Musculoskelet Disord. 2017 Feb 22;18(1):91. doi: 10.1186/s12891-017-1441-4.
36511925	Result

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000414 subjects FG001409 subjects
COMPLETED		FG000336 subjects FG001332 subjects
NOT COMPLETED		FG00078 subjects FG00177 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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. Diet & Exercise: Participants attended exercise and diet classes.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Knee Pain

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.

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

Posted

Mean

95% Confidence Interval

score on a scale

18 months

ID	Title	Description

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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. Diet & Exercise: Participants attended exercise and diet classes.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Car Accident	Injury, poisoning and procedural complications		Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Fall	Injury, poisoning and procedural complications		Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Dr. Stephen Messier	Wake Forest University	336-758-5849		messier@wfu.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 26, 2020	Dec 14, 2022	Prot_SAP_001.pdf
ICF	No	No	Yes	Informed Consent Form	Nov 7, 2022	Jun 1, 2023	ICF_002.pdf

Condition Browse Module

ID	Term
D010003	Osteoarthritis
D009043	Motor Activity
D015431	Weight Loss

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Intervention Browse Module

ID	Term
D004032	Diet
D015444	Exercise

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D009043	Motor Activity

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0007 BG0013 BG00210
Not Hispanic or Latino	BG000407 BG001401 BG002808
Unknown or Not Reported	BG0000 BG0015 BG0025

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0011 BG0022
Asian	BG0002 BG0011 BG0023
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG000111 BG001116 BG002227
White	BG000289 BG001281 BG002570
More than one race	BG00011 BG00110 BG00221
Unknown or Not Reported	BG0000 BG0010 BG0020

Womac pain score

Range, 0 to 20 (0, no pain; 2 to 8, mild; >8 to 14, moderate; and >14 to 20, severe); between-group Minimal clinically important differences (MCID) = 1.6, calculated as half the Standard Deviation (SD).

Mean

Standard Deviation

score on a scale

Title

Denominators

Categories

Title	Measurements
	BG0007.5± 3.2 BG0017.5± 3.3 BG0027.5± 3.2

Secondary

Function

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).

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

Posted

Mean

95% Confidence Interval

score on a scale

18 months

ID	Title	Description
OG000	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. Diet & Exercise: Participants attended exercise and diet classes.
OG001	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. Attention Control: Participants attended healthy living classes and received health newsletters and phone calls/emails/texts.

Units	Counts
Participants	OG000325 OG001311

Title

Denominators

Categories

Title	Measurements
	OG00016.5(15.3 to 17.7) OG00119.8(18.6 to 21.0)

Secondary

Health Related Quality of Life (SF-36) Physical Subscale

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.

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

Posted

Mean

95% Confidence Interval

score on a scale

18 months

ID	Title	Description
OG000	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. Diet & Exercise: Participants attended exercise and diet classes.
OG001	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. Attention Control: Participants attended healthy living classes and received health newsletters and phone calls/emails/texts.

Units	Counts
Participants	OG000321 OG001306

Title

Denominators

Categories

Title	Measurements
	OG00041.4(40.2 to 42.6) OG00137.6(36.3 to 38.8)

Secondary

Mobility (Six Minute Walk)

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.

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

Posted

Mean

95% Confidence Interval

meters

18 months

ID	Title	Description
OG000	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. Diet & Exercise: Participants attended exercise and diet classes.
OG001	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. Attention Control: Participants attended healthy living classes and received health newsletters and phone calls/emails/texts.

Units	Counts
Participants	OG000247 OG001219

Title

Denominators

Categories

Title	Measurements
	OG000419(411 to 428) OG001376(368 to 385)

Other Pre-specified

Cost-effectiveness

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.

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.

Posted

18 months

ID	Title	Description
OG000	Diet & Exercise	Participants will attend an exercise class 3 days/week for 18 months. The exercise program will consist 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 will also attend individual and group diet sessions. Each participant's minimum weight loss goal will be 10% of baseline body weight. Diet & Exercise: Participants will attend exercise and diet classes.
OG001	Attention Control	The attention control intervention will cover an 18-month period. There will be five total face to face group meetings over the 18 months, with one meeting each at months 1, 3, 6, 9, and 15; and during the other months (months 2-5, 7-11, 13-17) participants will receive a combination of informational packets, webinars, phone sessions, and/or emails based on continued monitoring of participant needs and delivered via their preferred mode of contact. Attention Control: Participants will attend healthy living classes and receive health newsletters and phone calls/emails/texts.

Units	Counts
Participants	OG0000 OG0010