ForgIng New Paths to Prevent DIabeTes (FINDIT)

Prediabetes Clinical Trial

— FINDIT  

Official title:

Improving Veteran Engagement in Diabetes Prevention (CDA 13-267)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747108
• Other study ID #: CDX 15-001
• Secondary ID: CDA 13-267
• Status: Completed
• Phase: N/A
• Start date: December 2, 2015
• Est. completion date: March 30, 2020

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: March 30, 2020
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Prediabetes
• Prediabetic State

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	VA Ann Arbor Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3 and 12 months
Secondary	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.	3 months and 12 months
Secondary	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.	Baseline, 2 weeks, 3 months, and 12 months
Secondary	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.	2 weeks, 3 months, and 12 months
Secondary	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).	Baseline, 2 weeks, 3 months, and 12 months
Secondary	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).	Baseline, 3 months and 12 months
Secondary	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.	Baseline, 3 months and 12 months
Secondary	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.	Baseline, 2 weeks, 3 months, and 12 months