Novel Intervention Linking Public Housing With Primary Care to Prevent Diabetes

Not Applicable

Completed

• Conditions: Obesity; Cardiovascular Risk Factor; Diabetes Mellitus Risk
• Interventions: Behavioral: 24 week community based DPP Group Lifestyle Balance Program; Behavioral: Wait-List Control community based DPP Group Lifestyle Balance Program

• Registration Number: NCT03526237
• Lead Sponsor: Medical University of South Carolina

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)

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-04-24
• Primary Completion: 2016-09-30
• Study Completion: 2017-07-01
• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-16
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-30
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. 21 years of age or older
2. Body-mass index of > 25 kg/m2 or waist circumference >35 inches
3. ADA diabetes risk assessment > at risk for pre-diabetes
4. Casual capillary blood glucose > 110 mg/dl <200
5. Access to phone
6. Resident in or surrounding partnering Public Housing neighborhood and eligible for FHCN services

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Exclusion Criteria

1. Exclusions for diseases likely to limit lifespan and/or increase risk of interventions: a) Cancer requiring treatment in the past 5 years; b) Cardiovascular disease: "Yes" response to any item on the modified Physical Activity Readiness Questionnaire; Uncontrolled hypertension: SBP >180 mmHg or DBP >105 mmHg; Heart attack, stroke, or transient ischemic attack in the past 6 months; c) Lung disease: Chronic obstructive airways disease or asthma requiring home oxygen
2. Exclusions related to metabolism: a) Diabetes at baseline; b) Casual capillary blood glucose >200 mg/dl; c) History of anti-diabetic medication use (oral agents or insulin) except during gestational diabetes; d) Pregnant female; e) Self-report of disease associated with disordered glucose metabolism: Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis
3. Exclusion for conditions or behaviors likely to affect the conduct of the study: a) Unable or unwilling to provide informed consent; b) Unable to read written English

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
The 24-week treatment	24 week community based DPP Group Lifestyle Balance Program	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.
Wait-list Control	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.

Primary Outcome Measures

Name	Time	Method
Change in BMI	Wk. 12 and 24	weight and height will be combined to report BMI in kg/m\^2)

Secondary Outcome Measures

Name	Time	Method
Change in Waist circumference	Wk 12 and 24	waist (abdominal) circumference in centimeters
Change in Lipids (LDL, HDL, Total Cholesterol and Triglycerides)	Wk. 12 and 24	Measured using a capillary blood sample Cholestech LDX
Change in A1C	Wk 12 and 24	Measured using a capillary blood sample DCA 2000 analyzer
Change in Diet and exercise Behaviors	Wk 12 and 24	Assessed by the Health Promoting Lifestyle Profile II