Novel Intervention Linking Public Housing With Primary Care to Prevent Diabetes

Study Overview
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Brief Summary
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(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
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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.

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

Conditions
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Diabetes Mellitus Risk, Obesity, Cardiovascular Risk Factor

Intervention / Treatment
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* Behavioral: 24 week community based DPP Group Lifestyle Balance Program
* Behavioral: Wait-List Control community based DPP Group Lifestyle Balance Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 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 Exclusion Criteria: 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 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 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The 24-week treatment<br>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<br>* 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.<br>|
| Other: Wait-list Control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI | weight and height will be combined to report BMI in kg/m^2) | Wk. 12 and 24 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, prevention, risk, obesity, weight loss, community based