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Independent Weight Loss Maintenance for Communities With Arthritis in North Carolina: the I-CAN Clinical Trial (I-CAN)

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ClinicalTrials.gov Identifier: NCT03832296
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
The study team is currently conducting a pragmatic, community-based assessor-blinded randomized controlled trial (RCT) in overweight and obese adults > 50 years with knee OA in both urban and rural counties in North Carolina. As the participants randomized to the 18 month diet and exercise group in the WE-CAN study successfully complete the intervention (≥ 5% weight loss), the study team has the unique opportunity to evaluate the effectiveness of a theoretically-based tapered weight maintenance intervention. Eligible participants will be randomized to either the weight-loss maintenance or health education attention control groups.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Behavioral: Weight-Loss Maintenance Behavioral: Health Education (Attention Control) Not Applicable

Detailed Description:

Results from the Intensive Diet and Exercise for Arthritis (IDEA) trial showed that 10% diet-induced weight loss combined with exercise (D+E) was twice as effective at relieving knee pain and improving function and mobility as previous long-term weight loss and exercise programs in similar cohorts. The treatment effects of D+E on these clinical outcomes were mediated by changes in self-efficacy over the course of the trial. However, most people tend to regain most or all of the lost weight in three to five years. The challenge is maintaining the weight loss and sustaining the efficacy of the intervention.

Our current trial (WE-CAN) is designed to adapt the successful IDEA intervention to real-world clinical and community settings. As WE-CAN participants in the D+E group complete their intervention, the investigators will leverage our organizational infrastructure to maintain weight-loss without supervised intervention by increasing participant confidence to establish and adhere to a routine of good exercise and diet behaviors independently.

Participants will include 212 older adults aged ≥ 51 yrs. with knee osteoarthritis (OA) who achieved a weight loss ≥ 5% in the D+E intervention arm of the WE-CAN trial. All WE-CAN participants meet the ACR clinical criteria for knee OA, which includes knee pain on most days of the week plus at least three of the following six: age ≥ 50 years, stiffness < 30 min/day, crepitus, bony tenderness, bony enlargement, and/or no palpable warmth. Eligible WE-CAN D+E participants will be randomized to either 6-month facilitated weight-loss maintenance or health education control interventions. The primary aim is to compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on maintaining weight loss subsequent to a 12-month unsupervised follow-up period. Secondary aims will compare the two interventions on WOMAC knee pain and function, health-related quality of life (SF-36), 6-minute walk distance, and weight-loss maintenance self-efficacy following the 12-month unsupervised period. The study team will also establish the cost-effectiveness of a 6-month facilitated weight-loss maintenance intervention for older adults with knee OA by conducting cost-effectiveness and budgetary impact analyses using data from the current trial in a validated computer-simulated model of knee OA.

There have been numerous attempts to prevent weight regain in adults. This study is significant in that it is designed to encourage older adults with knee OA that have experienced significant weight loss to develop strategies that will build self-efficacy for maintaining weight loss on their own long after the active intervention ends.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will include 212 older adults aged ≥ 51 yrs. with knee OA who achieved a weight loss ≥ 5% in the D+E intervention arm of the WE-CAN trial. Eligible WE-CAN D+E participants will be randomized to either the weight-loss maintenance or health education attention control groups.
Masking: Single (Outcomes Assessor)
Masking Description: Each eligible participant will be randomized to one of the two arms of the clinical trial (weight-loss maintenance, control) according to a variable block-length algorithm that will be controlled by the Data Management Group. Randomization will be stratified by intervention site to ensure nearly equal sample sizes for the two interventions to balance local population characteristics. Randomization uses a web-based system that is part of the study data management system. Intervention visits will not include any assessments and outcome assessors will remain blinded to group assignment. The lead biostatistician of the Data Management Group will develop the randomization table.
Primary Purpose: Supportive Care
Official Title: Independent Weight Loss Maintenance for Communities With Arthritis in North Carolina: the I-CAN Clinical Trial
Actual Study Start Date : March 29, 2018
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Weight-Loss Maintenance
Weight Loss Maintenance Intervention
Behavioral: Weight-Loss Maintenance
Over the course of the first 6-months, participants will build their self-efficacy to maintain weight loss on their own, empowered to do what is needed to achieve personal goals and long-term behavior change (months 7-18). The first 6 months of I-CAN will prepare participants for successful independent weight-loss maintenance in months 7-18. During the 12-month independent weight-loss maintenance phase participants exercise on their own and maintain their weight loss (or increase weight loss if they choose) with the only contact from interventionists being two newsletters at months 9 and 15.

Active Comparator: Health Education (Attention Control)
Health Education Intervention
Behavioral: Health Education (Attention Control)
Participants in the control group will attend an individual session during month 1, and a monthly face-to-face group meeting during months 2-6. The sessions will provide attention, social interaction, and physician-based health education. Participants will receive a newsletter during months 9 and 15.




Primary Outcome Measures :
  1. Weight-Loss Maintenance [ Time Frame: 18 Months ]
    Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on maintaining weight loss subsequent to a 12-month unsupervised follow-up period.


Secondary Outcome Measures :
  1. Knee Pain measured by the WOMAC Index [ Time Frame: 18 Months ]
    The investigators will measure self-reported pain using the WOMAC (scores will be pulled from the KOOS Questionnaire in which the WOMAC is embedded). The pain index assesses participants' pain on a scale, ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater dysfunction.

  2. Function measured by the WOMAC Index [ Time Frame: 18 Months ]
    The investigators will measure self-reported physical function using the WOMAC (scores will be pulled from the KOOS Questionnaire in which the WOMAC is embedded). The LK version asks participants to indicate on a scale from 0 (none) to 4 (extreme) the degree of difficulty experienced in the last week due to knee OA. Individual scores for the 17 items are totaled to generate a summary score that could range from 0-68, with higher scores indicating poorer function.

  3. Health Related Quality of Life: SF-36 [ Time Frame: 18 Months ]
    Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on health-related quality of life (SF-36) subsequent to a 12-month unsupervised follow-up period. Two summary scores are acquired: physical health and mental health. Range=0-100. Higher scores indicate better health.

  4. Mobility- 6 minute walk test [ Time Frame: 18 Months ]
    The primary mobility measure will be 6-minute walk distance. Participants are told to walk as far as possible in 6 minutes on an established course.

  5. Self-Efficacy - Perceived Stress: questionnaire [ Time Frame: 18 Months ]
    Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The perceived stress questionnaire will measure the degree to which people perceive their lives as stressful. Range = 0-40. Higher numbers indicate higher stress.

  6. Self-Efficacy - Walking Efficacy for Duration: walking efficacy for duration scale [ Time Frame: 18 Months ]
    Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The walking efficacy for duration scale measures one's ability to walk/jog at a moderately fast pace for various durations. Range 0-100. A higher score indicates a higher self-efficacy.

  7. Self-Efficacy - PANAS [ Time Frame: 18 Months ]
    Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Positive and Negative Affect (PANAS) measures both positive and negative affect, leading to more insightful outlooks regarding participants' feeling states. This scale consists of 20 items that reflect the intensity of how the participant "feels" right now. Range=10-50 for each subscale. A higher score for positive affect indicates a higher level of positive affect. A higher score for negative affect indicates a higher level of negative affect.

  8. Self-Efficacy - Gait Efficacy - gait efficacy/environmental efficacy scale [ Time Frame: 18 Months ]
    Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The gait efficacy/environmental efficacy scale will ask the participants' confidence in performing certain activities. Confidence in performing activities. Participants will be asked to indicate their level of confidence being able to complete different tasks. Range=0-100. A higher score indicates higher self-efficacy.

  9. Self-Efficacy - Satisfaction with Life: Satisfaction with life scale [ Time Frame: 18 Months ]
    Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Satisfaction with life scale is focused to assess global life satisfaction. Range=5 to 35. A higher scale indicates a higher level of life satisfaction.

  10. Self-Efficacy - Weight Efficacy Scale [ Time Frame: 18 Months ]
    Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Weight Efficacy Lifestyle Questionnaire (WEL) is a 20-item measure employed to assess self-efficacy for weight management. Range=0 to 180. Higher numbers indicate better confidence.

  11. Self-Efficacy - Adherence Self Efficacy Scale [ Time Frame: 18 Months ]
    Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The adherence questionnaire is designed to assess beliefs in one's ability (confidence) to continue exercising at various intensities and frequencies. Range=0-100. A higher score indicates higher self-efficacy.

  12. Self-Efficacy - Barriers Self-Efficacy to Exercise [ Time Frame: 18 Months ]
    Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Barriers Self-Efficacy to Exercise measures confidence in dealing with barriers to exercise. Range=0-100. Higher numbers indicate higher confidence.

  13. Self-Efficacy - Multidimensional Outcome Expectations for Exercise Scale (MOEES): questionnaire [ Time Frame: 18 Months ]
    Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The MOEES questionnaire consists of three subscales: physical outcome expectations (score range 6-30), social outcome expectations (score range 4-20), and self-evaluative outcome expectations (score range 5-25). Each subscale is scored by summing the numerical ratings for each response. Higher scores are indicative of higher levels of outcome expectations for exercise.

  14. Self-Efficacy - Perceived Barriers: questionnaire [ Time Frame: 18 Months ]
    Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The perceived barriers questionnaire measures a person's perceptions to barriers to performing exercise. The questionnaire is scored by finding the mean for each response (range = 1-5). Higher scores indicate higher perception of barriers.

  15. Self-Efficacy - Weight Loss Maintenance: questionnaire [ Time Frame: 18 Months ]
    Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy for maintaining weight loss. Range=0-100. Higher scores indicate more confidence in maintaining weight loss.

  16. Cost-Effectiveness [ Time Frame: 18 Months ]
    Resource utilization will be collected by questionnaire. MD and non-MD office visits will be collected via self-report with domains including visits to clinicians (physicians, nurses, physical therapists, others), tests, medications, injections, surgery, alternative therapies. The number of visits associated with utilization of each of 4 domains, MD visits, non-MD visits, ED visits, and inpatient stays, will be examined.

  17. Cost-Effectiveness- WPAI [ Time Frame: 18 Months ]
    The Work Productivity and Activity Impairment index (WPAI) will be used to assess absenteeism and reduced productivity while at work (presenteeism). Outcome (OC) scores can be derived from the WPAI: OC1, percent work time missed due to health, (percentage of absenteeism); percent impairment while working due to health, (percentage of presenteeism); percent overall work impairment due to health, percent activity impairment due to health. For all 4 outcomes, greater scores (range 0-100%) indicate greater impact of health.


Other Outcome Measures:
  1. Mobility - SPPB & GaitRite [ Time Frame: 18 Months ]
    The Short Physical Performance Battery (SPPB) will be used to measure mobility. The SPPB is comprised of the following tests (balance, walking speed, and chair rise). The scores range from 0 (worst performance) to 12 (best performance). Mobility will also be measured using the GaitRite.

  2. Mobility - stair activity [ Time Frame: 18 Months ]
    A test of ascending and descending stair activity measured by the time (in seconds) it takes to ascend and descend a flight of 8 steps with 20cm (8 inch) step height and handrail will also be performed.

  3. Pain Catastrophizing Scale (PCS) [ Time Frame: 18 Months ]
    The PCS questionnaire will be used to assess catastrophizing (rumination, magnification, and helplessness). The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. Lower scores indicate less pain.

  4. Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 18 Months ]
    The KOOS questionnaire will be used to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five separately scored subscales: 1) KOOS Pain; (2) KOOS Symptoms: Other symptoms such as swelling, restricted range of motion and mechanical symptoms; (3) KOOS ADL: Disability on the level of daily activities; (4) KOOS Sport/Rec: Disability on a level physically more demanding than activities of daily living; (5) KOOS QOL: Quality of life, mental and social aspects such as awareness and lifestyle changes. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  5. Intermittent and Constant Osteoarthritis Pain (ICOAP) [ Time Frame: 18 Months ]
    The ICOAP assesses pain in individuals with knee osteoarthritis taking into account both constant and intermittent pain experiences. Individual items are scored from 0 to 4. Each subscale (intermittent pain; constant pain; and total pain) are averaged. Lower numbers indicate lower pain.

  6. Health Literacy [ Time Frame: 18 Months ]
    Behavioral Risk Factor Surveillance System measures health literacy. Lower scores indicate higher literacy.

  7. Cognitive Functioning [ Time Frame: 18 Months ]
    The MOCA will be used to measure cognitive function. Scores range 0-30. Higher scores indicate higher cognitive functioning.

  8. Brief Resilience Scale [ Time Frame: 18 Months ]
    The Brief Resilience Scale will be used to measure resilience. The brief resilience scale (BRS) contains 6 items. The BRS is scored by reverse coding negatively worded questions (2, 4, and 6) and finding the mean of the six items. Range= 1-5. Lower scores indicate less resilience.

  9. Physical Activity [ Time Frame: 18 Months ]
    Physical activity will be measured by The Physical Activity Scale for the Elderly (PASE). 1-6 are scored in terms of hours per day over a 7-day period. Items 7-12 are scored as 1= engaged in activity or 0=did not engage in activity during the previous seven days. Scores range 0-100. Higher scores indicate more activity.

  10. Depression - Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 18 Months ]
    Depression will be measured using the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D contains 20-items and measures how often over the past week persons experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

  11. Health Related Quality of Life: Euroqol [ Time Frame: 18 Months ]
    Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on health-related quality of life. The EQ-5D comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Responses results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   51 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age ≥ 51
  • achieved a weight loss ≥ 5% in the D+E intervention arm of the WE-CAN trial

Exclusion Criteria:

  • Weight loss < 5% of baseline body weight
  • Significant co-morbid disease that would threaten safety or impair ability to participate in interventions or testing (Blindness; Type 1 diabetes; Severe coronary artery disease)
  • Inability to finish 18-month study or unlikely to be compliant (Planning to leave area > 2 month during the next 18 months)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832296


Contacts
Contact: Jovita J Newman, MA 336-758-3969 jollajk@wfu.edu

Locations
United States, North Carolina
Johnston County - UNC Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27516
Contact: Betsy Hackney    919-966-0574    bshackne@email.unc.edu   
Principal Investigator: Leigh Callahan, PhD         
Sub-Investigator: Richard Loeser, MD         
Haywood County - Haywood Regional Medical Center Recruiting
Clyde, North Carolina, United States, 28721
Contact: Kate Queen, MD       katequeen.queen@gmail.com   
Principal Investigator: Kate Queen, MD         
Forsyth County - Wake Forest University/Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27109
Contact: Jovita J Newman, MA    336-758-3969    jollajk@wfu.edu   
Principal Investigator: Shannon Mihalko, PhD         
Sub-Investigator: Stephen P Messier, PhD         
Sub-Investigator: Gary Miller, RD, PhD         
Principal Investigator: Daniel Beavers, PhD         
Sub-Investigator: Mary Lyles, MD         
Sub-Investigator: Paul DeVita, PhD         
Principal Investigator: Elena Losina, PhD         
Sub-Investigator: Jeff Katz, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Stephen P Messier, PhD Wake Forest University
Principal Investigator: Leigh Callahan, PhD University of North Carolina, Chapel Hill

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03832296     History of Changes
Other Study ID Numbers: WFU: IRB00033618
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators support data sharing and will comply with all NIH guidelines as outlined in the NIH Data Sharing Policy and Implementation Guidance document. The primary means of data sharing and dissemination will be through scientific publications and presentations. Ensuring patient privacy and confidentiality will be of primary importance in creating the files to be shared. All data files will be de-identified. De-identification procedures will meet HIPAA criteria detailed in the Code of Federal Regulations, Part 46, Section 164.514. The study team will create a link on our website that describes the data files. Documentation will also be provided along with the redacted data files. The documentation will include electronic versions of the protocol, data collection forms (with instructions for scoring, if needed), data dictionary, data code book, labels, and formats. Requests for data will be answered via completion of an online request form and data-sharing agreement.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: All data will be released within three years of completing collection, even if planned papers have not been written or accepted.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
Arthritis
Knee
weight loss

Additional relevant MeSH terms:
Arthritis
Weight Loss
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Rheumatic Diseases