Novel Intervention Linking Public Housing With Primary Care to Prevent Diabetes

NCT03526237 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-05-04

No results posted yet for this study

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)

Conditions

  • Diabetes Mellitus Risk
  • Obesity
  • Cardiovascular Risk Factor

Interventions

BEHAVIORAL

Wait-List Control community based DPP Group Lifestyle Balance Program

Control arm participants will receive: 1) Usual care in FQHC/primary care clinic 2) Individual counseling about pre-diabetes risk at baseline; mailed written NIDDK patient education materials (weight loss, physical activity, nutrition) at weeks 6, 12, 18; 2) At the end of the 24 week intervention, the wait list control arm will be invited to participate and receive the group based DPP sessions.

BEHAVIORAL

24 week community based DPP Group Lifestyle Balance Program

a) 12 weekly peer group (adapted Group Lifestyle Balance Program) sessions followed by 3 monthly group maintenance sessions held in Public Housing locations; b) Individual coaching and patient activation during 24 week period; 2) Community Outreach Care Coordination: Referral, navigation assistance, patient activation, and cross-linkage to FQHC services.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Gayenell S Magwood, PhD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-24
Primary Completion
2016-09-30
Completion
2017-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03526237 on ClinicalTrials.gov