PrediabetesFINDITNCT02747108
ForgIng New Paths to Prevent DIabeTes (FINDIT)
A study testing Blood Test Group Intervention and Brochure Group Intervention in people with Prediabetes, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- Blood Test Group Intervention and Brochure Group Intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2015to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
About this study
Official title: Improving Veteran Engagement in Diabetes Prevention (CDA 13-267)
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.
Read the 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
- Being tested
- Blood Test Group Intervention, Brochure Group Intervention
- Keywords
- Veterans, Type 2 Diabetes Mellitus, Prediabetes, Decision-making, Motivation, Health Promotion, Prevention and Control
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Test Group InterventionBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Brochure Group Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (8)
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.
Measured: 3 and 12 months
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.
Measured: 3 months and 12 months
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.
Measured: Baseline, 2 weeks, 3 months, and 12 months
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.
Measured: 2 weeks, 3 months, and 12 months
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).
Measured: Baseline, 2 weeks, 3 months, and 12 months
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).
Measured: Baseline, 3 months and 12 months
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.
Measured: Baseline, 3 months and 12 months
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.
Measured: Baseline, 2 weeks, 3 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start2 Dec 2015
- Primary completion1 Dec 2018
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Ann Arbor Healthcare System
- Responsible party
- Sponsor
- Investigators
- Jeffrey T. Kullgren, MD MPH MS, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747108
- Sponsor's protocol ID
- CDX 15-001
- Other IDs
- CDA 13-267
- Acronym
- FINDIT
- Status last verified
- Jul 2023
- First submitted
- 18 Apr 2016
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28388933
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Veteran Engagement in Diabetes Prevention (CDA 13-267)
- ClinicalTrials.gov ID
- NCT02747108
- Acronym / sponsor ID
- FINDIT / CDX 15-001
- Conditions
- Prediabetes
- Keywords
- Veterans, Type 2 Diabetes Mellitus, Prediabetes, Decision-making, Motivation, Health Promotion, Prevention and Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Ann Arbor Healthcare System
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Posted 10 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Test Group | Experimental | Behavioral: Blood Test Group InterventionPatients 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. |
| Brochure Group (usual care) | Active comparator | Behavioral: Brochure Group InterventionPatients will not complete an HbA1c test and will instead receive brief counseling and written information about recommended screenings and immunizations. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (11 listed)
- The investigators will exclude patients who are > 75 years of age
- are receiving chemotherapy for cancer, or have:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Test Group InterventionPatients 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. | Behavioural | Blood Test Group |
| Brochure Group InterventionParticipants 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. | Behavioural | Brochure Group (usual care) |
Primary outcome
Weight Change From Baseline to 12 Months
Time frame: 12 months
The primary outcome will be weight change 12 months after an HbA1c test and brief counseling or review of health promotion literature.
8 secondary outcomes
Change in Use of Medication for T2DM Prevention
Time frame: 3 and 12 months
Changes in Participation in a Weight Management Program
Time frame: 3 months and 12 months
Changes in Perception for Risk for T2DM
Time frame: Baseline, 2 weeks, 3 months, and 12 months
Changes in Knowledge of Strategies to Prevent T2DM
Time frame: 2 weeks, 3 months, and 12 months
Changes in Motivation to Prevent T2DM
Time frame: Baseline, 2 weeks, 3 months, and 12 months
Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM
Time frame: Baseline, 3 months and 12 months
Change in Physical Activity
Time frame: Baseline, 3 months and 12 months
Change in Mental Health
Time frame: Baseline, 2 weeks, 3 months, and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28388933Kullgren 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey T. Kullgren, MD MPH MS principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Test Group Intervention and Brochure Group Intervention in people with Prediabetes, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Change From Baseline to 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02747108, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.