Novel Intervention Linking Public Housing With Primary Care to Prevent Diabetes — SHAPE-Up  

Obesity Clinical Trial

Official title: Novel Intervention Linking Public Housing With Primary Care to Prevent Diabetes

Status Completed

Clinical Trial Summary

(Sisters Health And Primary CarE Uniting and Preventing Diabetes; aka SHAPE UP) will consist of: 1) Neighborhood DPP Intervention: group DPP sessions and individual coaching; 2) Preventive Care Coordination to FQHC: referral, navigation assistance, patient activation, linkage to primary care (community initiated referrals) and linkage to DPP program (FQHC initiated referrals)

Clinical Trial Description

SHAPE-UP we will use a randomized between groups wait-list design wherein the experimental treatment will be compared to best practices FHCN/FQHC services waitlist control (with an educational supplement for control). At the 24-week point, the waitlist control participants will be invited to receive the intervention. This combines a between groups RCT design with a phase change/within-group design for maximum efficiency with a limited N. Randomization will occur at the level of the individual participant. To sustain participant interest and to address obesity-related needs, control arm participants will receive Best Practices services including 1) Individual counseling about pre-diabetes risk at baseline; 2) mailed written materials at weeks 6, 12, 18; and 3) As needed additional FQHC Primary Care services (as mentioned, referral to the DPP obesity intervention and FHCN/FQHC primary care services will be bidirectional. The RE-AIM framework will guide process and impact evaluation measures of this intervention. ;

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Diabetes Mellitus
• Diabetes Mellitus Risk
• Obesity

• NCT number: NCT03526237
• Study type: Interventional
• Source: Medical University of South Carolina
• Status: Completed
• Phase: N/A
• Start date: April 24, 2015
• Completion date: July 1, 2017