ForgIng New Paths to Prevent DIabeTes (FINDIT)

NCT ID: NCT02747108

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-02
• Study Completion Date: 2020-03-30

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.

Conditions

Prediabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Blood Test Group

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.

Group Type: EXPERIMENTAL

Blood Test Group Intervention

Intervention Type: BEHAVIORAL

Patients randomly assigned to the Blood Test Group will complete an HbA1c blood test around the time of their next primary care appointment. Following the HbA1c test, their VA primary care provider will be notified of the test result and will be provided with a detailed interpretation of the result. Trained study staff will then provide brief counseling by phone and written information by mail about their test result. The brief counseling and written information will be based on the American Diabetes Association and National Diabetes Prevention Program guidelines and will emphasize the risk of progression to type 2 diabetes mellitus and the rationale for preventive strategies, encourage aerobic exercise and a calorie-restricted diet to promote and maintain weight loss, and set a goal of achieving and sustaining a weight loss of at least 5% of body weight.

Brochure Group (usual care)

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

Group Type: ACTIVE_COMPARATOR

Brochure Group Intervention

Intervention Type: BEHAVIORAL

Participants will be asked to review a handout from the National Center for Health Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations on or around the same date as their next primary care appointment.

Interventions

Blood Test Group Intervention

Patients randomly assigned to the Blood Test Group will complete an HbA1c blood test around the time of their next primary care appointment. Following the HbA1c test, their VA primary care provider will be notified of the test result and will be provided with a detailed interpretation of the result. Trained study staff will then provide brief counseling by phone and written information by mail about their test result. The brief counseling and written information will be based on the American Diabetes Association and National Diabetes Prevention Program guidelines and will emphasize the risk of progression to type 2 diabetes mellitus and the rationale for preventive strategies, encourage aerobic exercise and a calorie-restricted diet to promote and maintain weight loss, and set a goal of achieving and sustaining a weight loss of at least 5% of body weight.

Intervention Type: BEHAVIORAL

Brochure Group Intervention

Participants will be asked to review a handout from the National Center for Health Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations on or around the same date as their next primary care appointment.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Ann Arbor Healthcare System

FED

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey T. Kullgren, MD MPH MS

Role: PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System, Ann Arbor, MI

Locations

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28388933 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CDA 13-267

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDX 15-001

Identifier Type: -

Identifier Source: org_study_id