NCT02747108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
4 months until next milestone

Results Posted

Study results publicly available

August 10, 2020

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

3 years

First QC Date

April 18, 2016

Results QC Date

April 6, 2020

Last Update Submit

July 19, 2023

Conditions

Prediabetes

Keywords

VeteransType 2 Diabetes MellitusPrediabetesDecision-makingMotivationHealth PromotionPrevention and Control

Outcome Measures

Primary Outcomes (1)

  • Weight Change From Baseline to 12 Months

    The primary outcome will be weight change 12 months after an HbA1c test and brief counseling or review of health promotion literature.

    12 months

Secondary Outcomes (8)

  • Change in Use of Medication for T2DM Prevention

    3 and 12 months

  • Changes in Participation in a Weight Management Program

    3 months and 12 months

  • Changes in Perception for Risk for T2DM

    Baseline, 2 weeks, 3 months, and 12 months

  • Changes in Knowledge of Strategies to Prevent T2DM

    2 weeks, 3 months, and 12 months

  • Changes in Motivation to Prevent T2DM

    Baseline, 2 weeks, 3 months, and 12 months

  • +3 more secondary outcomes

Study Arms (2)

Blood Test Group

EXPERIMENTAL

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.

Behavioral: Blood Test Group Intervention

Brochure Group (usual care)

ACTIVE COMPARATOR

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

Behavioral: Brochure Group Intervention

Interventions

Blood Test Group InterventionBEHAVIORAL

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.

Blood Test Group
Brochure Group InterventionBEHAVIORAL

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.

Brochure Group (usual care)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

Related Publications (1)

  • 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.

    PMID: 28388933DERIVED

MeSH Terms

Conditions

Prediabetic StateDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Jeffrey Kullgren, MD, MS, MPH - Principal Investigator
Organization
VA Center for Clinical Management Research
jkullgre@med.umich.edu
(734) 845-3502

Study Officials

  • Jeffrey T. Kullgren, MD MPH MS

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 21, 2016

Study Start

December 2, 2015

Primary Completion

December 1, 2018

Study Completion

March 30, 2020

Last Updated

July 25, 2023

Results First Posted

August 10, 2020

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)