Independent Weight Loss Maintenance for Communities With Arthritis in North Carolina: the I-CAN Clinical Trial
I-CAN
1 other identifier
interventional
105
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2018
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2018
CompletedFirst Submitted
Initial submission to the registry
February 4, 2019
CompletedFirst Posted
Study publicly available on registry
February 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedFebruary 26, 2021
November 1, 2020
2.3 years
February 4, 2019
February 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight-Loss Maintenance
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.
18 Months
Secondary Outcomes (17)
Knee Pain measured by the WOMAC Index
18 Months
Function measured by the WOMAC Index
18 Months
Health Related Quality of Life: SF-36
18 Months
Mobility- 6 minute walk test
18 Months
Self-Efficacy - Perceived Stress: questionnaire
18 Months
- +12 more secondary outcomes
Other Outcomes (11)
Mobility - SPPB & GaitRite
18 Months
Mobility - stair activity
18 Months
Pain Catastrophizing Scale (PCS)
18 Months
- +8 more other outcomes
Study Arms (2)
Weight-Loss Maintenance
EXPERIMENTALWeight Loss Maintenance Intervention
Health Education (Attention Control)
ACTIVE COMPARATORHealth Education Intervention
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- age ≥ 51
- achieved a weight loss ≥ 5% in the D+E intervention arm of the WE-CAN trial
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Johnston County - UNC Chapel Hill
Chapel Hill, North Carolina, 27516, United States
Haywood County - Haywood Regional Medical Center
Clyde, North Carolina, 28721, United States
Forsyth County - Wake Forest University/Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen P Messier, PhD
Wake Forest University
- PRINCIPAL INVESTIGATOR
Leigh Callahan, PhD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2019
First Posted
February 6, 2019
Study Start
March 29, 2018
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
February 26, 2021
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- All data will be released within three years of completing collection, even if planned papers have not been written or accepted.
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.