ForgIng New Paths to Prevent DIabeTes (FINDIT)

VA Office of Research and Development

Status: Completed

Conditions: Prediabetes

Treatments: Behavioral: Blood Test Group Intervention; Behavioral: Brochure Group Intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02747108

CDA 13-267 (Other Grant/Funding Number)

CDX 15-001

Details and patient eligibility

About

This study will evaluate the effects of screening for type 2 diabetes mellitus (T2DM) and brief counseling about screening test results on weight and key health behaviors among Veterans with risk factors for T2DM. Study participants will be randomly assigned to one of two study groups: (1) Blood Test Group or (2) Brochure Group. Participants in the Blood Test Group will complete a blood test called hemoglobin A1c (HbA1c) which measures average blood sugar levels. Participants will receive brief counseling about the results from their primary care provider or someone authorized to speak on their behalf. Participants randomly selected for the Brochure Group will review a handout from the VA National Center for Health Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations. All participants will be asked to complete a survey prior to study group assignment, immediately after a Primary Care appointment, 3 months after enrollment, and 12 months after enrollment.

Full description

An essential step in designing effective strategies to improve patient engagement in behavior change is to better understand their current levels of engagement in these behaviors and determine which factors most influence their engagement. Within and outside the Veterans Health Administration (VHA), little is known about how patients with risk factors for T2DM view their risk of developing T2DM, what these patients understand about strategies to reduce this risk, and to what degree at-risk patients are currently engaging in behaviors to prevent T2DM. This project will generate important new data in these areas and will improve the investigators' understanding of the effects of a prediabetes diagnosis and brief counseling on engagement in behaviors to prevent T2DM and mediators of these behaviors.

Enrollment: 315 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The investigators will recruit 315 non-diabetic Veterans receiving primary care at the Ann Arbor VA Medical Center who meet the following inclusion criteria:

• willing to complete a HIPAA authorization form

• no HbA1c results in previous 12 months

• due for VA Primary Care appointment approximately 12 weeks of sending a recruitment letter and who have a body-mass index (BMI) 30 kg/m2

• or BMI 25 kg/m2 with > 1 obesity-related condition such as:

  • hypertension
  • hyperlipidemia
  • Hypoalphalipoproteinemia
  • Coronary Artery Disease
  • Peripheral Vascular Disease
  • Hypertriglyceridemia
  • past hemoglobin A1c (HbA1c) of 5.7 - 6.4
  • past diagnosis of Impaired Fasting Glucose (IFG)
  • or Impaired Glucose Tolerance (IGT)
  • or Polycystic Ovary Syndrome (PCOS)

Exclusion criteria

• The investigators will exclude patients who are > 75 years of age

• are receiving chemotherapy for cancer, or have:

  • dementia
  • diabetes
  • dementia
  • New York Heart Association Class III or IV congestive heart failure
  • pregnancy
  • Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 4 Chronic Obstructive Pulmonary Disease (COPD)
  • end-stage renal disease (ESRD)
  • cirrhosis
  • or have been hospitalized or received rehab for stroke or myocardial infarction within the past 6 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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315 participants in 2 patient groups

Blood Test Group

Experimental group

Description:

Patients will complete an HbA1c test and then receive brief counseling and written information about their test result based on the American Diabetes Association and National Diabetes Prevention Program guidelines.

Treatment:

Behavioral: Blood Test Group Intervention

Brochure Group (usual care)

Active Comparator group

Description:

Patients will not complete an HbA1c test and will instead receive brief counseling and written information about recommended screenings and immunizations.

Treatment:

Behavioral: Brochure Group Intervention