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

Sponsor

Medical University of South Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT03526237

Collaborator

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

Enrollment

Arms

26.3

Actual Duration (Months)

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Risk Obesity Cardiovascular Risk Factor	Behavioral: 24 week community based DPP Group Lifestyle Balance Program Behavioral: Wait-List Control community based DPP Group Lifestyle Balance Program	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Novel Intervention Linking Public Housing With Primary Care to Prevent Diabetes

Actual Study Start Date :

Apr 24, 2015

Actual Primary Completion Date :

Sep 30, 2016

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The 24-week treatment 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 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.
Other: Wait-list Control 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 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.

Arm

Intervention/Treatment

Experimental: The 24-week treatment

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

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.

Other: Wait-list Control

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

Outcome Measures

Primary Outcome Measures

Change in BMI [Wk. 12 and 24]
weight and height will be combined to report BMI in kg/m^2)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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