Clinical trial NCT03832296: Independent Weight Loss Maintenance for Communities With Arthritis in North Carolina: the I-CAN Clinical Trial
Official title: Independent Weight Loss Maintenance for Communities With Arthritis in North Carolina: the I-CAN Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: Arthritis
Knee
weight loss
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 105
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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)

Primary outcomes:
measure: Weight-Loss Maintenance
timeFrame: 18 Months
Secondary outcomes:
measure: Knee Pain measured by the WOMAC Index
timeFrame: 18 Months
measure: Function measured by the WOMAC Index
timeFrame: 18 Months
measure: Health Related Quality of Life: SF-36
timeFrame: 18 Months
measure: Mobility- 6 minute walk test
timeFrame: 18 Months
measure: Self-Efficacy - Perceived Stress: questionnaire
timeFrame: 18 Months
measure: Self-Efficacy - Walking Efficacy for Duration: walking efficacy for duration scale
timeFrame: 18 Months
measure: Self-Efficacy - PANAS
timeFrame: 18 Months
measure: Self-Efficacy - Gait Efficacy - gait efficacy/environmental efficacy scale
timeFrame: 18 Months
measure: Self-Efficacy - Satisfaction with Life: Satisfaction with life scale
timeFrame: 18 Months
measure: Self-Efficacy - Weight Efficacy Scale
timeFrame: 18 Months
measure: Self-Efficacy - Adherence Self Efficacy Scale
timeFrame: 18 Months
measure: Self-Efficacy - Barriers Self-Efficacy to Exercise
timeFrame: 18 Months
measure: Self-Efficacy - Multidimensional Outcome Expectations for Exercise Scale (MOEES): questionnaire
timeFrame: 18 Months
measure: Self-Efficacy - Perceived Barriers: questionnaire
timeFrame: 18 Months
measure: Self-Efficacy - Weight Loss Maintenance: questionnaire
timeFrame: 18 Months
measure: Cost-Effectiveness
timeFrame: 18 Months
measure: Cost-Effectiveness- WPAI
timeFrame: 18 Months
Other outcomes:
measure: Mobility - SPPB & GaitRite
timeFrame: 18 Months
measure: Mobility - stair activity
timeFrame: 18 Months
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 18 Months
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 18 Months
measure: Intermittent and Constant Osteoarthritis Pain (ICOAP)
timeFrame: 18 Months
measure: Health Literacy
timeFrame: 18 Months
measure: Cognitive Functioning
timeFrame: 18 Months
measure: Brief Resilience Scale
timeFrame: 18 Months
measure: Physical Activity
timeFrame: 18 Months
measure: Depression - Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 18 Months
measure: Health Related Quality of Life: Euroqol
timeFrame: 18 Months
Locations:
city: Chapel Hill
country: United States
facility: Johnston County - UNC Chapel Hill
state: North Carolina
city: Clyde
country: United States
facility: Haywood County - Haywood Regional Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth County - Wake Forest University/Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University
name: Stephen P Messier, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Leigh Callahan, PhD
role: PRINCIPAL_INVESTIGATOR
References: