NCT03526237

Brief 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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
Last Updated

May 4, 2020

Status Verified

April 1, 2020

Enrollment Period

1.4 years

First QC Date

March 29, 2018

Last Update Submit

April 30, 2020

Conditions

Diabetes Mellitus RiskObesityCardiovascular Risk Factor

Keywords

diabetespreventionriskobesityweight losscommunity based

Outcome Measures

Primary Outcomes (1)

  • Change in BMI

    weight and height will be combined to report BMI in kg/m\^2)

    Wk. 12 and 24

Secondary Outcomes (4)

  • Change in Waist circumference

    Wk 12 and 24

  • Change in Lipids (LDL, HDL, Total Cholesterol and Triglycerides)

    Wk. 12 and 24

  • Change in A1C

    Wk 12 and 24

  • Change in Diet and exercise Behaviors

    Wk 12 and 24

Study Arms (2)

The 24-week treatment

EXPERIMENTAL

The 24-week treatment, Sisters Health And Primary CarE Uniting and Preventing Diabetes (SHAPE UP) 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.

Behavioral: 24 week community based DPP Group Lifestyle Balance Program

Wait-list Control

OTHER

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: Wait-List Control community based DPP Group Lifestyle Balance Program

Interventions

24 week community based DPP Group Lifestyle Balance ProgramBEHAVIORAL

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.

The 24-week treatment
Wait-List Control community based DPP Group Lifestyle Balance ProgramBEHAVIORAL

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.

Wait-list Control

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Body-mass index of \> 25 kg/m2 or waist circumference \>35 inches
  • ADA diabetes risk assessment \> at risk for pre-diabetes
  • Casual capillary blood glucose \> 110 mg/dl \<200
  • Access to phone
  • Resident in or surrounding partnering Public Housing neighborhood and eligible for FHCN services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityDiabetes MellitusWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBody Weight Changes

Study Officials

  • Gayenell S Magwood, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2018

First Posted

May 16, 2018

Study Start

April 24, 2015

Primary Completion

September 30, 2016

Study Completion

July 1, 2017

Last Updated

May 4, 2020

Record last verified: 2020-04