Clinical trial NCT03526237: Novel Intervention Linking Public Housing With Primary Care to Prevent Diabetes
Official title: Novel Intervention Linking Public Housing With Primary Care to Prevent Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Risk
Obesity
Cardiovascular Risk Factor
Keywords: diabetes
prevention
risk
obesity
weight loss
community based
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-05-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in BMI
timeFrame: Wk. 12 and 24
Secondary outcomes:
measure: Change in Waist circumference
timeFrame: Wk 12 and 24
measure: Change in Lipids (LDL, HDL, Total Cholesterol and Triglycerides)
timeFrame: Wk. 12 and 24
measure: Change in A1C
timeFrame: Wk 12 and 24
measure: Change in Diet and exercise Behaviors
timeFrame: Wk 12 and 24
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Gayenell S Magwood, PhD
role: PRINCIPAL_INVESTIGATOR
References: