Skip to content

ForgIng New Paths to Prevent DIabeTes (FINDIT)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02747108
Acronym
FINDIT
Enrollment
315
Registered
2016-04-21
Start date
2015-12-02
Completion date
2020-03-30
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes

Keywords

Veterans, Type 2 Diabetes Mellitus, Prediabetes, Decision-making, Motivation, Health Promotion, Prevention and Control

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.

Interventions

BEHAVIORALBlood 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.

BEHAVIORALBrochure 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.

Sponsors

VA Ann Arbor Healthcare System
CollaboratorFED
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Weight Change From Baseline to 12 Months12 monthsThe primary outcome will be weight change 12 months after an HbA1c test and brief counseling or review of health promotion literature.

Secondary

MeasureTime frameDescription
Changes in Participation in a Weight Management Program3 months and 12 monthsThe 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 T2DMBaseline, 2 weeks, 3 months, and 12 monthsThe 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 T2DM2 weeks, 3 months, and 12 monthsThe 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.
Change in Use of Medication for T2DM Prevention3 and 12 monthsThe 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 Self-efficacy to Engage in Behaviors to Prevent T2DMBaseline, 3 months and 12 monthsThe 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 ActivityBaseline, 3 months and 12 monthsThe 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 HealthBaseline, 2 weeks, 3 months, and 12 monthsThe 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.
Changes in Motivation to Prevent T2DMBaseline, 2 weeks, 3 months, and 12 monthsThe 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).

Countries

United States

Participant flow

Recruitment details

Veterans that met preliminary study eligibility criteria were mailed a letter about the study and were contacted by a Research Assistant 10 days later by phone to gauge their participation interest. Recruitment was conducted between December 2015 and February 2017.

Pre-assignment details

Participants that met study criteria and had an upcoming primary care appointment were sent a Baseline Survey to complete as a requirement for randomization. Those that did not complete the Baseline Survey or whose primary care appointments were cancelled and not rescheduled were not randomized and thus excluded from analysis.

Participants by arm

ArmCount
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. 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.
253
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. 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.
62
Total315

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath22
Overall StudyProtocol Violation20
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicBlood Test GroupTotalBrochure Group (Usual Care)
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
120 Participants150 Participants30 Participants
Age, Categorical
Between 18 and 65 years
133 Participants165 Participants32 Participants
Age, Continuous61.01 Years
STANDARD_DEVIATION 10.89
60.98 Years
STANDARD_DEVIATION 11.06
60.87 Years
STANDARD_DEVIATION 11.83
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants8 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
244 Participants304 Participants60 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants3 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
4 Participants6 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
17 Participants19 Participants2 Participants
Race (NIH/OMB)
More than one race
23 Participants25 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants9 Participants6 Participants
Race (NIH/OMB)
White
206 Participants256 Participants50 Participants
Region of Enrollment
United States
253 Participants315 Participants62 Participants
Sex: Female, Male
Female
22 Participants27 Participants5 Participants
Sex: Female, Male
Male
231 Participants288 Participants57 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 2532 / 62
other
Total, other adverse events
3 / 2531 / 62
serious
Total, serious adverse events
0 / 2530 / 62

Outcome results

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.

Time frame: 12 months

Population: The population consisted of Veterans ages 75 and younger, who were due for an HbA1c lab, and met inclusion and exclusion criteria at the time of enrollment.

ArmMeasureValue (MEAN)Dispersion
Blood Test Group (Normoglycemia)Weight Change From Baseline to 12 Months-.995535 PoundsStandard Deviation 15.39902
Brochure Group (Usual Care)Weight Change From Baseline to 12 Months-2.1333341 PoundsStandard Deviation 12.697408
Blood Test Group (Prediabetes)Weight Change From Baseline to 12 Months.039778 PoundsStandard Deviation 12.69741
Blood Test Group (Diabetes)Weight Change From Baseline to 12 Months-4.17 PoundsStandard Deviation 9.906009
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.

Time frame: Baseline, 2 weeks, 3 months, and 12 months

Population: The population consisted of veterans ages 75 and younger, who were due for an HbA1c lab, met inclusion and exclusion criteria at the time of enrollment, and had data available for this assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Blood Test Group (Normoglycemia)Change in Mental HealthBaseline44.995 Score on a scaleStandard Error 9.63
Blood Test Group (Normoglycemia)Change in Mental Health2 weeks46.366 Score on a scaleStandard Error 1.018
Blood Test Group (Normoglycemia)Change in Mental Health3 months45.347 Score on a scaleStandard Error 1.037
Blood Test Group (Normoglycemia)Change in Mental Health12 months47.082 Score on a scaleStandard Error 1.082
Brochure Group (Usual Care)Change in Mental Health2 weeks46.389 Score on a scaleStandard Error 1.496
Brochure Group (Usual Care)Change in Mental Health3 months48.249 Score on a scaleStandard Error 1.531
Brochure Group (Usual Care)Change in Mental Health12 months47.308 Score on a scaleStandard Error 1.37
Brochure Group (Usual Care)Change in Mental HealthBaseline44.264 Score on a scaleStandard Error 1.43
Blood Test Group (Prediabetes)Change in Mental Health3 months46.926 Score on a scaleStandard Error 1.095
Blood Test Group (Prediabetes)Change in Mental Health2 weeks46.512 Score on a scaleStandard Error 1.071
Blood Test Group (Prediabetes)Change in Mental Health12 months47.58 Score on a scaleStandard Error 1.066
Blood Test Group (Prediabetes)Change in Mental HealthBaseline45.373 Score on a scaleStandard Error 1.086
Blood Test Group (Diabetes)Change in Mental Health12 months40.085 Score on a scaleStandard Error 4.352
Blood Test Group (Diabetes)Change in Mental Health2 weeks44.806 Score on a scaleStandard Error 2.548
Blood Test Group (Diabetes)Change in Mental HealthBaseline37.926 Score on a scaleStandard Error 2.291
Blood Test Group (Diabetes)Change in Mental Health3 months48.703 Score on a scaleStandard Error 3.139
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.

Time frame: Baseline, 3 months and 12 months

Population: The population consisted of veterans ages 75 and younger, who were due for an HbA1c lab, met inclusion and exclusion criteria at the time of enrollment, and had data available for this assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Blood Test Group (Normoglycemia)Change in Physical Activity12 months.489 Proportion of RespondentsStandard Error 0.043
Blood Test Group (Normoglycemia)Change in Physical Activity3 months.45 Proportion of RespondentsStandard Error 0.042
Blood Test Group (Normoglycemia)Change in Physical ActivityBaseline.542 Proportion of RespondentsStandard Error 0.044
Brochure Group (Usual Care)Change in Physical Activity12 months.5 Proportion of RespondentsStandard Error 0.063
Brochure Group (Usual Care)Change in Physical Activity3 months.517 Proportion of RespondentsStandard Error 0.063
Brochure Group (Usual Care)Change in Physical ActivityBaseline.5 Proportion of RespondentsStandard Error 0.066
Blood Test Group (Prediabetes)Change in Physical ActivityBaseline.495 Proportion of RespondentsStandard Error 0.047
Blood Test Group (Prediabetes)Change in Physical Activity3 months.438 Proportion of RespondentsStandard Error 0.047
Blood Test Group (Prediabetes)Change in Physical Activity12 months.457 Proportion of RespondentsStandard Error 0.047
Blood Test Group (Diabetes)Change in Physical Activity12 months.364 Proportion of RespondentsStandard Error 0.145
Blood Test Group (Diabetes)Change in Physical Activity3 months.091 Proportion of RespondentsStandard Error 0.087
Blood Test Group (Diabetes)Change in Physical ActivityBaseline.273 Proportion of RespondentsStandard Error 0.138
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.

Time frame: 3 and 12 months

Population: The population consisted of veterans ages 75 and younger, who were due for an HbA1c lab, met inclusion and exclusion criteria at the time of enrollment, and had data available for this assessment

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Blood Test Group (Normoglycemia)Change in Use of Medication for T2DM Prevention12 monthsNo Metformin Use132 Participants
Blood Test Group (Normoglycemia)Change in Use of Medication for T2DM Prevention3 monthsNo Metformin Use134 Participants
Blood Test Group (Normoglycemia)Change in Use of Medication for T2DM Prevention12 monthsMetformin Use2 Participants
Blood Test Group (Normoglycemia)Change in Use of Medication for T2DM Prevention3 monthsMetformin Use0 Participants
Brochure Group (Usual Care)Change in Use of Medication for T2DM Prevention3 monthsNo Metformin Use59 Participants
Brochure Group (Usual Care)Change in Use of Medication for T2DM Prevention12 monthsNo Metformin Use59 Participants
Brochure Group (Usual Care)Change in Use of Medication for T2DM Prevention3 monthsMetformin Use3 Participants
Brochure Group (Usual Care)Change in Use of Medication for T2DM Prevention12 monthsMetformin Use3 Participants
Blood Test Group (Prediabetes)Change in Use of Medication for T2DM Prevention3 monthsNo Metformin Use106 Participants
Blood Test Group (Prediabetes)Change in Use of Medication for T2DM Prevention12 monthsMetformin Use2 Participants
Blood Test Group (Prediabetes)Change in Use of Medication for T2DM Prevention3 monthsMetformin Use0 Participants
Blood Test Group (Prediabetes)Change in Use of Medication for T2DM Prevention12 monthsNo Metformin Use104 Participants
Blood Test Group (Diabetes)Change in Use of Medication for T2DM Prevention12 monthsNo Metformin Use9 Participants
Blood Test Group (Diabetes)Change in Use of Medication for T2DM Prevention3 monthsNo Metformin Use8 Participants
Blood Test Group (Diabetes)Change in Use of Medication for T2DM Prevention12 monthsMetformin Use2 Participants
Blood Test Group (Diabetes)Change in Use of Medication for T2DM Prevention3 monthsMetformin Use3 Participants
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.

Time frame: 2 weeks, 3 months, and 12 months

Population: The population consisted of veterans ages 75 and younger, who were due for an HbA1c lab, met inclusion and exclusion criteria at the time of enrollment, and had data available for this assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Blood Test Group (Normoglycemia)Changes in Knowledge of Strategies to Prevent T2DM12 months1.03 Score on a scaleStandard Deviation 0.72
Blood Test Group (Normoglycemia)Changes in Knowledge of Strategies to Prevent T2DM3 months1.04 Score on a scaleStandard Deviation 0.64
Blood Test Group (Normoglycemia)Changes in Knowledge of Strategies to Prevent T2DM2 weeks1.03 Score on a scaleStandard Deviation 0.7
Brochure Group (Usual Care)Changes in Knowledge of Strategies to Prevent T2DM3 months1.01 Score on a scaleStandard Deviation 0.67
Brochure Group (Usual Care)Changes in Knowledge of Strategies to Prevent T2DM2 weeks1.10 Score on a scaleStandard Deviation 0.65
Brochure Group (Usual Care)Changes in Knowledge of Strategies to Prevent T2DM12 months0.97 Score on a scaleStandard Deviation 0.68
Blood Test Group (Prediabetes)Changes in Knowledge of Strategies to Prevent T2DM2 weeks1.34 Score on a scaleStandard Deviation 0.77
Blood Test Group (Prediabetes)Changes in Knowledge of Strategies to Prevent T2DM3 months1.08 Score on a scaleStandard Deviation 0.66
Blood Test Group (Prediabetes)Changes in Knowledge of Strategies to Prevent T2DM12 months1.08 Score on a scaleStandard Deviation 0.69
Blood Test Group (Diabetes)Changes in Knowledge of Strategies to Prevent T2DM3 months1.09 Score on a scaleStandard Deviation 0.83
Blood Test Group (Diabetes)Changes in Knowledge of Strategies to Prevent T2DM12 months1.18 Score on a scaleStandard Deviation 0.87
Blood Test Group (Diabetes)Changes in Knowledge of Strategies to Prevent T2DM2 weeks1.09 Score on a scaleStandard Deviation 0.7
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).

Time frame: Baseline, 2 weeks, 3 months, and 12 months

Population: The population consisted of veterans ages 75 and younger, who were due for an HbA1c lab, met inclusion and exclusion criteria at the time of enrollment, and had data available for this assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Blood Test Group (Normoglycemia)Changes in Motivation to Prevent T2DMBaseline6.618 Score on a scaleStandard Error 0.239
Blood Test Group (Normoglycemia)Changes in Motivation to Prevent T2DM2 weeks6.558 Score on a scaleStandard Error 0.24
Blood Test Group (Normoglycemia)Changes in Motivation to Prevent T2DM3 months6.471 Score on a scaleStandard Error 0.229
Blood Test Group (Normoglycemia)Changes in Motivation to Prevent T2DM12 months6.793 Score on a scaleStandard Error 0.234
Brochure Group (Usual Care)Changes in Motivation to Prevent T2DM2 weeks7.246 Score on a scaleStandard Error 0.321
Brochure Group (Usual Care)Changes in Motivation to Prevent T2DM3 months7.018 Score on a scaleStandard Error 0.323
Brochure Group (Usual Care)Changes in Motivation to Prevent T2DM12 months6.981 Score on a scaleStandard Error 0.371
Brochure Group (Usual Care)Changes in Motivation to Prevent T2DMBaseline7.237 Score on a scaleStandard Error 0.358
Blood Test Group (Prediabetes)Changes in Motivation to Prevent T2DM3 months7.442 Score on a scaleStandard Error 0.221
Blood Test Group (Prediabetes)Changes in Motivation to Prevent T2DM2 weeks7.67 Score on a scaleStandard Error 0.215
Blood Test Group (Prediabetes)Changes in Motivation to Prevent T2DM12 months7.207 Score on a scaleStandard Error 0.236
Blood Test Group (Prediabetes)Changes in Motivation to Prevent T2DMBaseline6.676 Score on a scaleStandard Error 0.272
Blood Test Group (Diabetes)Changes in Motivation to Prevent T2DM12 months6.889 Score on a scaleStandard Error 0.897
Blood Test Group (Diabetes)Changes in Motivation to Prevent T2DM2 weeks7.9 Score on a scaleStandard Error 0.432
Blood Test Group (Diabetes)Changes in Motivation to Prevent T2DMBaseline6.455 Score on a scaleStandard Error 0.627
Blood Test Group (Diabetes)Changes in Motivation to Prevent T2DM3 months7 Score on a scaleStandard Error 0.537
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.

Time frame: 3 months and 12 months

Population: The population consisted of veterans ages 75 and younger, who were due for an HbA1c lab, met inclusion and exclusion criteria at the time of enrollment, and had data available for this assessment.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Blood Test Group (Normoglycemia)Changes in Participation in a Weight Management Program3 monthsParticipated in weight management program17 Participants
Blood Test Group (Normoglycemia)Changes in Participation in a Weight Management Program3 monthsDid not participate in weight management program117 Participants
Blood Test Group (Normoglycemia)Changes in Participation in a Weight Management Program12 monthsParticipated in weight management program20 Participants
Blood Test Group (Normoglycemia)Changes in Participation in a Weight Management Program12 monthsDid not participate in weight management program114 Participants
Brochure Group (Usual Care)Changes in Participation in a Weight Management Program3 monthsDid not participate in weight management program54 Participants
Brochure Group (Usual Care)Changes in Participation in a Weight Management Program12 monthsParticipated in weight management program10 Participants
Brochure Group (Usual Care)Changes in Participation in a Weight Management Program12 monthsDid not participate in weight management program52 Participants
Brochure Group (Usual Care)Changes in Participation in a Weight Management Program3 monthsParticipated in weight management program8 Participants
Blood Test Group (Prediabetes)Changes in Participation in a Weight Management Program12 monthsParticipated in weight management program8 Participants
Blood Test Group (Prediabetes)Changes in Participation in a Weight Management Program3 monthsDid not participate in weight management program98 Participants
Blood Test Group (Prediabetes)Changes in Participation in a Weight Management Program12 monthsDid not participate in weight management program98 Participants
Blood Test Group (Prediabetes)Changes in Participation in a Weight Management Program3 monthsParticipated in weight management program8 Participants
Blood Test Group (Diabetes)Changes in Participation in a Weight Management Program12 monthsDid not participate in weight management program9 Participants
Blood Test Group (Diabetes)Changes in Participation in a Weight Management Program3 monthsDid not participate in weight management program9 Participants
Blood Test Group (Diabetes)Changes in Participation in a Weight Management Program3 monthsParticipated in weight management program2 Participants
Blood Test Group (Diabetes)Changes in Participation in a Weight Management Program12 monthsParticipated in weight management program2 Participants
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.

Time frame: Baseline, 2 weeks, 3 months, and 12 months

Population: The population consisted of veterans ages 75 and younger, who were due for an HbA1c lab, met inclusion and exclusion criteria at the time of enrollment, and had data available for this assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Blood Test Group (Normoglycemia)Changes in Perception for Risk for T2DMBaseline20.775 Score on a scaleStandard Error 1.84
Blood Test Group (Normoglycemia)Changes in Perception for Risk for T2DM2 weeks16.356 Score on a scaleStandard Error 1.704
Blood Test Group (Normoglycemia)Changes in Perception for Risk for T2DM3 months19 Score on a scaleStandard Error 1.738
Blood Test Group (Normoglycemia)Changes in Perception for Risk for T2DM12 months18.947 Score on a scaleStandard Error 1.943
Brochure Group (Usual Care)Changes in Perception for Risk for T2DM2 weeks23.684 Score on a scaleStandard Error 2.519
Brochure Group (Usual Care)Changes in Perception for Risk for T2DM3 months26.667 Score on a scaleStandard Error 3.036
Brochure Group (Usual Care)Changes in Perception for Risk for T2DM12 months23.585 Score on a scaleStandard Error 3.265
Brochure Group (Usual Care)Changes in Perception for Risk for T2DMBaseline21.724 Score on a scaleStandard Error 2.611
Blood Test Group (Prediabetes)Changes in Perception for Risk for T2DM3 months35.851 Score on a scaleStandard Error 2.377
Blood Test Group (Prediabetes)Changes in Perception for Risk for T2DM2 weeks36.327 Score on a scaleStandard Error 2.41
Blood Test Group (Prediabetes)Changes in Perception for Risk for T2DM12 months32.5 Score on a scaleStandard Error 2.504
Blood Test Group (Prediabetes)Changes in Perception for Risk for T2DMBaseline27.596 Score on a scaleStandard Error 2.554
Blood Test Group (Diabetes)Changes in Perception for Risk for T2DM12 months43.333 Score on a scaleStandard Error 7.183
Blood Test Group (Diabetes)Changes in Perception for Risk for T2DM2 weeks56 Score on a scaleStandard Error 6.452
Blood Test Group (Diabetes)Changes in Perception for Risk for T2DMBaseline35.455 Score on a scaleStandard Error 6.112
Blood Test Group (Diabetes)Changes in Perception for Risk for T2DM3 months51.25 Score on a scaleStandard Error 6.031
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).

Time frame: Baseline, 3 months and 12 months

Population: The population consisted of veterans ages 75 and younger, who were due for an HbA1c lab, met inclusion and exclusion criteria at the time of enrollment, and had data available for this assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Blood Test Group (Normoglycemia)Changes in Self-efficacy to Engage in Behaviors to Prevent T2DMBaseline4.869 Score on a scaleStandard Error 0.134
Blood Test Group (Normoglycemia)Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM12 months5.07 Score on a scaleStandard Error 0.134
Blood Test Group (Normoglycemia)Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM3 months4.926 Score on a scaleStandard Error 0.125
Brochure Group (Usual Care)Changes in Self-efficacy to Engage in Behaviors to Prevent T2DMBaseline5.082 Score on a scaleStandard Error 0.172
Brochure Group (Usual Care)Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM12 months5.31 Score on a scaleStandard Error 0.195
Brochure Group (Usual Care)Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM3 months5.005 Score on a scaleStandard Error 0.192
Blood Test Group (Prediabetes)Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM3 months4.826 Score on a scaleStandard Error 0.148
Blood Test Group (Prediabetes)Changes in Self-efficacy to Engage in Behaviors to Prevent T2DMBaseline4.747 Score on a scaleStandard Error 0.152
Blood Test Group (Prediabetes)Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM12 months4.832 Score on a scaleStandard Error 0.151
Blood Test Group (Diabetes)Changes in Self-efficacy to Engage in Behaviors to Prevent T2DMBaseline4.341 Score on a scaleStandard Error 0.445
Blood Test Group (Diabetes)Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM12 months4.75 Score on a scaleStandard Error 0.57
Blood Test Group (Diabetes)Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM3 months4.906 Score on a scaleStandard Error 0.432

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026