search
Back to results

ForgIng New Paths to Prevent DIabeTes (FINDIT) (FINDIT)

Primary Purpose

Prediabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Test Group Intervention
Brochure Group Intervention
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetes focused on measuring Veterans, Type 2 Diabetes Mellitus, Prediabetes, Decision-making, Motivation, Health Promotion, Prevention and Control

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blood Test Group

Brochure Group (usual care)

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Use of Medication for T2DM Prevention
The investigators will use medical record data and survey data to evaluate changes in use of medication for T2DM prevention after an HbA1c test and brief counseling or review of health promotion literature.
Changes in Participation in a Weight Management Program
The investigators will use survey data to evaluate changes in participation in a weight management program after an HbA1c test and brief counseling or review of health promotion literature.
Changes in Perception for Risk for T2DM
The investigators will use survey data to evaluate changes in perception of risk for T2DM after an HbA1c test and brief counseling or review of health promotion literature. The Adriaanse T2DM Risk Perception Scale, which was included in the survey, measured self-assessed risk perception from 0 denoting no choice of developing T2DM to 100 denoting absolute confidence in developing T2DM.
Changes in Knowledge of Strategies to Prevent T2DM
The investigators will use survey data to evaluate changes in knowledge of strategies to prevent T2DM after an HbA1c test and brief counseling or review of health promotion literature. Respondents were given 3 open-ended questions to report things they could do to prevent T2DM. Each respective response to the 3 questions were coded and scored according to whether they indicated engagement in the following activities: weight loss, physical activity, use of metformin, or enrollment into a diabetes prevention program. Each question denoted with a positive response were coded with 1 whereas those that did not were coded as a 0. The three questions were summed into a final score ranging from 0 (no report of engagement in the aforementioned healthy activities) with the worst outcome to 3 (a report of 3 of the 4 aforementioned healthy activities) with the best outcome.
Changes in Motivation to Prevent T2DM
The investigators will use survey data to evaluate changes in motivation to prevent T2DM after an HbA1c test and brief counseling or review of health promotion literature. The Treatment Self-Regulation Questionnaire (TSRQ) was included in the survey and respondents were asked about their level of motivation from 1 (Not at all motivated) to 10 (Highly motivated).
Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM
The investigators will use survey data to evaluate changes in self-efficacy to engage in behaviors to prevent T2DM after an HbA1c test and brief counseling or review of health promotion literature. The Perceived Competence Scale was used to measure respondent self-efficacy from 1 (lowest) to 7 (highest).
Change in Physical Activity
The investigators will use survey data to evaluate changes in physical activity after an HbA1c test and brief counseling or review of health promotion literature. The International Physical Activity Questionnaire - Short Form (IPAQ-SF) was used to measure physical activity change. Respondents were asked to report how many hours and minutes within the past week they completed of vigorous physical activity, moderate physical activity, and brisk walking. The total sum of minutes for these three questions were subsequently coded into a yes/no binary variable for whether respondents met a recommended 150 minutes of overall physical activity within 7 days of being assessed. The values provided reflect a proportion of respondents that met or exceeded the 150 minute threshold of overall physical activity based on the newly generated variable that combined total minutes of vigorous physical activity, moderate physical activity, and brisk walking.
Change in Mental Health
The investigators will use survey data to evaluate changes in SF-12 mental health scores after an HbA1c test and brief counseling or review of health promotion literature. The SF-12 provides a calculation of (1) a physical score (PCS-12) generated from a subset of questions focused on physical health and (2) a mental health score (MCS-12) generated from a subset of questions focused on mental health. The data provided represent the mean score of the PCS-12 and MCS-12. Scores range from 0 to 100, where a zero score indicates the lowest level of physical/mental health measured by the scales and 100 indicates the highest level of physical/mental health.

Full Information

First Posted
April 18, 2016
Last Updated
July 19, 2023
Sponsor
VA Office of Research and Development
Collaborators
VA Ann Arbor Healthcare System
search

1. Study Identification

Unique Protocol Identification Number
NCT02747108
Brief Title
ForgIng New Paths to Prevent DIabeTes (FINDIT)
Acronym
FINDIT
Official Title
Improving Veteran Engagement in Diabetes Prevention (CDA 13-267)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 2, 2015 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
VA Ann Arbor Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes
Keywords
Veterans, Type 2 Diabetes Mellitus, Prediabetes, Decision-making, Motivation, Health Promotion, Prevention and Control

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood Test Group
Arm Type
Experimental
Arm 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.
Arm Title
Brochure Group (usual care)
Arm Type
Active Comparator
Arm Description
Patients will not complete an HbA1c test and will instead receive brief counseling and written information about recommended screenings and immunizations.
Intervention Type
Behavioral
Intervention Name(s)
Blood Test Group Intervention
Intervention Description
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
Intervention Name(s)
Brochure Group Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight Change From Baseline to 12 Months
Description
The primary outcome will be weight change 12 months after an HbA1c test and brief counseling or review of health promotion literature.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Use of Medication for T2DM Prevention
Description
The investigators will use medical record data and survey data to evaluate changes in use of medication for T2DM prevention after an HbA1c test and brief counseling or review of health promotion literature.
Time Frame
3 and 12 months
Title
Changes in Participation in a Weight Management Program
Description
The investigators will use survey data to evaluate changes in participation in a weight management program after an HbA1c test and brief counseling or review of health promotion literature.
Time Frame
3 months and 12 months
Title
Changes in Perception for Risk for T2DM
Description
The investigators will use survey data to evaluate changes in perception of risk for T2DM after an HbA1c test and brief counseling or review of health promotion literature. The Adriaanse T2DM Risk Perception Scale, which was included in the survey, measured self-assessed risk perception from 0 denoting no choice of developing T2DM to 100 denoting absolute confidence in developing T2DM.
Time Frame
Baseline, 2 weeks, 3 months, and 12 months
Title
Changes in Knowledge of Strategies to Prevent T2DM
Description
The investigators will use survey data to evaluate changes in knowledge of strategies to prevent T2DM after an HbA1c test and brief counseling or review of health promotion literature. Respondents were given 3 open-ended questions to report things they could do to prevent T2DM. Each respective response to the 3 questions were coded and scored according to whether they indicated engagement in the following activities: weight loss, physical activity, use of metformin, or enrollment into a diabetes prevention program. Each question denoted with a positive response were coded with 1 whereas those that did not were coded as a 0. The three questions were summed into a final score ranging from 0 (no report of engagement in the aforementioned healthy activities) with the worst outcome to 3 (a report of 3 of the 4 aforementioned healthy activities) with the best outcome.
Time Frame
2 weeks, 3 months, and 12 months
Title
Changes in Motivation to Prevent T2DM
Description
The investigators will use survey data to evaluate changes in motivation to prevent T2DM after an HbA1c test and brief counseling or review of health promotion literature. The Treatment Self-Regulation Questionnaire (TSRQ) was included in the survey and respondents were asked about their level of motivation from 1 (Not at all motivated) to 10 (Highly motivated).
Time Frame
Baseline, 2 weeks, 3 months, and 12 months
Title
Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM
Description
The investigators will use survey data to evaluate changes in self-efficacy to engage in behaviors to prevent T2DM after an HbA1c test and brief counseling or review of health promotion literature. The Perceived Competence Scale was used to measure respondent self-efficacy from 1 (lowest) to 7 (highest).
Time Frame
Baseline, 3 months and 12 months
Title
Change in Physical Activity
Description
The investigators will use survey data to evaluate changes in physical activity after an HbA1c test and brief counseling or review of health promotion literature. The International Physical Activity Questionnaire - Short Form (IPAQ-SF) was used to measure physical activity change. Respondents were asked to report how many hours and minutes within the past week they completed of vigorous physical activity, moderate physical activity, and brisk walking. The total sum of minutes for these three questions were subsequently coded into a yes/no binary variable for whether respondents met a recommended 150 minutes of overall physical activity within 7 days of being assessed. The values provided reflect a proportion of respondents that met or exceeded the 150 minute threshold of overall physical activity based on the newly generated variable that combined total minutes of vigorous physical activity, moderate physical activity, and brisk walking.
Time Frame
Baseline, 3 months and 12 months
Title
Change in Mental Health
Description
The investigators will use survey data to evaluate changes in SF-12 mental health scores after an HbA1c test and brief counseling or review of health promotion literature. The SF-12 provides a calculation of (1) a physical score (PCS-12) generated from a subset of questions focused on physical health and (2) a mental health score (MCS-12) generated from a subset of questions focused on mental health. The data provided represent the mean score of the PCS-12 and MCS-12. Scores range from 0 to 100, where a zero score indicates the lowest level of physical/mental health measured by the scales and 100 indicates the highest level of physical/mental health.
Time Frame
Baseline, 2 weeks, 3 months, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey T. Kullgren, MD MPH MS
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105-2303
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28388933
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.
Results Reference
derived

Learn more about this trial

ForgIng New Paths to Prevent DIabeTes (FINDIT)

We'll reach out to this number within 24 hrs