Novel Intervention Linking Public Housing With Primary Care to Prevent Diabetes

NCT ID: NCT03526237

Last Updated: 2020-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-24
• Study Completion Date: 2017-07-01

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.

Conditions

Diabetes Mellitus Risk; Obesity; Cardiovascular Risk Factor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

24 week community based DPP Group Lifestyle Balance Program

Intervention Type: BEHAVIORAL

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.

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.

Group Type: OTHER

Wait-List Control community based DPP Group Lifestyle Balance Program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gayenell S Magwood, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Other Identifiers

1R34DK097724

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00036688

Identifier Type: -

Identifier Source: org_study_id