Clinical trial NCT02747108: ForgIng New Paths to Prevent DIabeTes (FINDIT)
Official title: Improving Veteran Engagement in Diabetes Prevention (CDA 13-267)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Keywords: Veterans
Type 2 Diabetes Mellitus
Prediabetes
Decision-making
Motivation
Health Promotion
Prevention and Control
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Ann Arbor Healthcare System
First posted: 2016-04-21
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight Change From Baseline to 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Change in Use of Medication for T2DM Prevention
timeFrame: 3 and 12 months
measure: Changes in Participation in a Weight Management Program
timeFrame: 3 months and 12 months
measure: Changes in Perception for Risk for T2DM
timeFrame: Baseline, 2 weeks, 3 months, and 12 months
measure: Changes in Knowledge of Strategies to Prevent T2DM
timeFrame: 2 weeks, 3 months, and 12 months
measure: Changes in Motivation to Prevent T2DM
timeFrame: Baseline, 2 weeks, 3 months, and 12 months
measure: Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM
timeFrame: Baseline, 3 months and 12 months
measure: Change in Physical Activity
timeFrame: Baseline, 3 months and 12 months
measure: Change in Mental Health
timeFrame: Baseline, 2 weeks, 3 months, and 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Jeffrey T. Kullgren, MD MPH MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kullgren JT, Youles B, Shetty S, Richardson C, Fagerlin A, Heisler M. ForgIng New paths in DIabetes PrevenTion (FINDIT): Study Protocol for a Randomized Controlled Trial. Trials. 2017 Apr 8;18(1):167. doi: 10.1186/s13063-017-1887-6.