Trial Outcomes & Findings for ForgIng New Paths to Prevent DIabeTes (FINDIT) (NCT NCT02747108)
NCT ID: NCT02747108
Last Updated: 2023-07-25
Results Overview
The primary outcome will be weight change 12 months after an HbA1c test and brief counseling or review of health promotion literature.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
315 participants
Primary outcome timeframe
12 months
Results posted on
2023-07-25
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
253
|
62
|
|
Overall Study
COMPLETED
|
248
|
60
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
The number of males and females randomized to each arm. Each column represents the arm whereas the row represents the gender with the row totaling the number of males and females that enrolled in the study.
Baseline characteristics by cohort
| Measure |
Blood Test Group
n=253 Participants
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.
|
Brochure Group (Usual Care)
n=62 Participants
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.
|
Total
n=315 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
133 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
120 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Age, Continuous
|
61.01 Years
STANDARD_DEVIATION 10.89 • n=5 Participants
|
60.87 Years
STANDARD_DEVIATION 11.83 • n=7 Participants
|
60.98 Years
STANDARD_DEVIATION 11.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants • The number of males and females randomized to each arm. Each column represents the arm whereas the row represents the gender with the row totaling the number of males and females that enrolled in the study.
|
5 Participants
n=7 Participants • The number of males and females randomized to each arm. Each column represents the arm whereas the row represents the gender with the row totaling the number of males and females that enrolled in the study.
|
27 Participants
n=5 Participants • The number of males and females randomized to each arm. Each column represents the arm whereas the row represents the gender with the row totaling the number of males and females that enrolled in the study.
|
|
Sex: Female, Male
Male
|
231 Participants
n=5 Participants • The number of males and females randomized to each arm. Each column represents the arm whereas the row represents the gender with the row totaling the number of males and females that enrolled in the study.
|
57 Participants
n=7 Participants • The number of males and females randomized to each arm. Each column represents the arm whereas the row represents the gender with the row totaling the number of males and females that enrolled in the study.
|
288 Participants
n=5 Participants • The number of males and females randomized to each arm. Each column represents the arm whereas the row represents the gender with the row totaling the number of males and females that enrolled in the study.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
244 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
206 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
23 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
253 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
The primary outcome will be weight change 12 months after an HbA1c test and brief counseling or review of health promotion literature.
Outcome measures
| Measure |
Blood Test Group (Normoglycemia)
n=112 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the normoglycemia range of less than 5.7.
|
Brochure Group (Usual Care)
n=54 Participants
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.
|
Blood Test Group (Prediabetes)
n=90 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
Blood Test Group (Diabetes)
n=10 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
|---|---|---|---|---|
|
Weight Change From Baseline to 12 Months
|
-.995535 Pounds
Standard Deviation 15.39902
|
-2.1333341 Pounds
Standard Deviation 12.697408
|
.039778 Pounds
Standard Deviation 12.69741
|
-4.17 Pounds
Standard Deviation 9.906009
|
SECONDARY outcome
Timeframe: 3 and 12 monthsPopulation: 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
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.
Outcome measures
| Measure |
Blood Test Group (Normoglycemia)
n=134 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the normoglycemia range of less than 5.7.
|
Brochure Group (Usual Care)
n=62 Participants
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.
|
Blood Test Group (Prediabetes)
n=106 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
Blood Test Group (Diabetes)
n=11 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
|---|---|---|---|---|
|
Change in Use of Medication for T2DM Prevention
3 months · Metformin Use
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Change in Use of Medication for T2DM Prevention
3 months · No Metformin Use
|
134 Participants
|
59 Participants
|
106 Participants
|
8 Participants
|
|
Change in Use of Medication for T2DM Prevention
12 months · Metformin Use
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Change in Use of Medication for T2DM Prevention
12 months · No Metformin Use
|
132 Participants
|
59 Participants
|
104 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 3 months and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Blood Test Group (Normoglycemia)
n=134 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the normoglycemia range of less than 5.7.
|
Brochure Group (Usual Care)
n=62 Participants
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.
|
Blood Test Group (Prediabetes)
n=106 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
Blood Test Group (Diabetes)
n=11 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
|---|---|---|---|---|
|
Changes in Participation in a Weight Management Program
3 months · Participated in weight management program
|
17 Participants
|
8 Participants
|
8 Participants
|
2 Participants
|
|
Changes in Participation in a Weight Management Program
3 months · Did not participate in weight management program
|
117 Participants
|
54 Participants
|
98 Participants
|
9 Participants
|
|
Changes in Participation in a Weight Management Program
12 months · Participated in weight management program
|
20 Participants
|
10 Participants
|
8 Participants
|
2 Participants
|
|
Changes in Participation in a Weight Management Program
12 months · Did not participate in weight management program
|
114 Participants
|
52 Participants
|
98 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 3 months, and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Blood Test Group (Normoglycemia)
n=134 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the normoglycemia range of less than 5.7.
|
Brochure Group (Usual Care)
n=63 Participants
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.
|
Blood Test Group (Prediabetes)
n=107 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
Blood Test Group (Diabetes)
n=11 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
|---|---|---|---|---|
|
Changes in Perception for Risk for T2DM
Baseline
|
20.775 Score on a scale
Standard Error 1.84
|
21.724 Score on a scale
Standard Error 2.611
|
27.596 Score on a scale
Standard Error 2.554
|
35.455 Score on a scale
Standard Error 6.112
|
|
Changes in Perception for Risk for T2DM
2 weeks
|
16.356 Score on a scale
Standard Error 1.704
|
23.684 Score on a scale
Standard Error 2.519
|
36.327 Score on a scale
Standard Error 2.41
|
56 Score on a scale
Standard Error 6.452
|
|
Changes in Perception for Risk for T2DM
3 months
|
19 Score on a scale
Standard Error 1.738
|
26.667 Score on a scale
Standard Error 3.036
|
35.851 Score on a scale
Standard Error 2.377
|
51.25 Score on a scale
Standard Error 6.031
|
|
Changes in Perception for Risk for T2DM
12 months
|
18.947 Score on a scale
Standard Error 1.943
|
23.585 Score on a scale
Standard Error 3.265
|
32.5 Score on a scale
Standard Error 2.504
|
43.333 Score on a scale
Standard Error 7.183
|
SECONDARY outcome
Timeframe: 2 weeks, 3 months, and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Blood Test Group (Normoglycemia)
n=134 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the normoglycemia range of less than 5.7.
|
Brochure Group (Usual Care)
n=62 Participants
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.
|
Blood Test Group (Prediabetes)
n=106 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
Blood Test Group (Diabetes)
n=11 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
|---|---|---|---|---|
|
Changes in Knowledge of Strategies to Prevent T2DM
2 weeks
|
1.03 Score on a scale
Standard Deviation 0.70
|
1.10 Score on a scale
Standard Deviation 0.65
|
1.34 Score on a scale
Standard Deviation 0.77
|
1.09 Score on a scale
Standard Deviation 0.70
|
|
Changes in Knowledge of Strategies to Prevent T2DM
3 months
|
1.04 Score on a scale
Standard Deviation 0.64
|
1.01 Score on a scale
Standard Deviation 0.67
|
1.08 Score on a scale
Standard Deviation 0.66
|
1.09 Score on a scale
Standard Deviation 0.83
|
|
Changes in Knowledge of Strategies to Prevent T2DM
12 months
|
1.03 Score on a scale
Standard Deviation 0.72
|
0.97 Score on a scale
Standard Deviation 0.68
|
1.08 Score on a scale
Standard Deviation 0.69
|
1.18 Score on a scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 3 months, and 12 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Blood Test Group (Normoglycemia)
n=134 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the normoglycemia range of less than 5.7.
|
Brochure Group (Usual Care)
n=63 Participants
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.
|
Blood Test Group (Prediabetes)
n=107 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
Blood Test Group (Diabetes)
n=11 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
|---|---|---|---|---|
|
Changes in Motivation to Prevent T2DM
12 months
|
6.793 Score on a scale
Standard Error .234
|
6.981 Score on a scale
Standard Error .371
|
7.207 Score on a scale
Standard Error .236
|
6.889 Score on a scale
Standard Error .897
|
|
Changes in Motivation to Prevent T2DM
3 months
|
6.471 Score on a scale
Standard Error .229
|
7.018 Score on a scale
Standard Error .323
|
7.442 Score on a scale
Standard Error .221
|
7 Score on a scale
Standard Error .537
|
|
Changes in Motivation to Prevent T2DM
Baseline
|
6.618 Score on a scale
Standard Error .239
|
7.237 Score on a scale
Standard Error .358
|
6.676 Score on a scale
Standard Error .272
|
6.455 Score on a scale
Standard Error .627
|
|
Changes in Motivation to Prevent T2DM
2 weeks
|
6.558 Score on a scale
Standard Error .24
|
7.246 Score on a scale
Standard Error .321
|
7.67 Score on a scale
Standard Error .215
|
7.9 Score on a scale
Standard Error .432
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 12 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Blood Test Group (Normoglycemia)
n=134 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the normoglycemia range of less than 5.7.
|
Brochure Group (Usual Care)
n=63 Participants
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.
|
Blood Test Group (Prediabetes)
n=107 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
Blood Test Group (Diabetes)
n=11 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
|---|---|---|---|---|
|
Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM
Baseline
|
4.869 Score on a scale
Standard Error .134
|
5.082 Score on a scale
Standard Error .172
|
4.747 Score on a scale
Standard Error .152
|
4.341 Score on a scale
Standard Error .445
|
|
Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM
3 months
|
4.926 Score on a scale
Standard Error .125
|
5.005 Score on a scale
Standard Error .192
|
4.826 Score on a scale
Standard Error .148
|
4.906 Score on a scale
Standard Error .432
|
|
Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM
12 months
|
5.07 Score on a scale
Standard Error .134
|
5.31 Score on a scale
Standard Error .195
|
4.832 Score on a scale
Standard Error .151
|
4.75 Score on a scale
Standard Error .57
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Blood Test Group (Normoglycemia)
n=134 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the normoglycemia range of less than 5.7.
|
Brochure Group (Usual Care)
n=63 Participants
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.
|
Blood Test Group (Prediabetes)
n=107 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
Blood Test Group (Diabetes)
n=11 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
|---|---|---|---|---|
|
Change in Physical Activity
Baseline
|
.542 Proportion of Respondents
Standard Error .044
|
.5 Proportion of Respondents
Standard Error .066
|
.495 Proportion of Respondents
Standard Error .047
|
.273 Proportion of Respondents
Standard Error .138
|
|
Change in Physical Activity
3 months
|
.45 Proportion of Respondents
Standard Error .042
|
.517 Proportion of Respondents
Standard Error .063
|
.438 Proportion of Respondents
Standard Error .047
|
.091 Proportion of Respondents
Standard Error .087
|
|
Change in Physical Activity
12 months
|
.489 Proportion of Respondents
Standard Error .043
|
.5 Proportion of Respondents
Standard Error .063
|
.457 Proportion of Respondents
Standard Error .047
|
.364 Proportion of Respondents
Standard Error .145
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 3 months, and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Blood Test Group (Normoglycemia)
n=134 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the normoglycemia range of less than 5.7.
|
Brochure Group (Usual Care)
n=63 Participants
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.
|
Blood Test Group (Prediabetes)
n=107 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
Blood Test Group (Diabetes)
n=11 Participants
Participants in the Blood Test Group with Baseline HbA1c results in the prediabetic range of 5.7 - 6.4.
|
|---|---|---|---|---|
|
Change in Mental Health
Baseline
|
44.995 Score on a scale
Standard Error 9.63
|
44.264 Score on a scale
Standard Error 1.43
|
45.373 Score on a scale
Standard Error 1.086
|
37.926 Score on a scale
Standard Error 2.291
|
|
Change in Mental Health
2 weeks
|
46.366 Score on a scale
Standard Error 1.018
|
46.389 Score on a scale
Standard Error 1.496
|
46.512 Score on a scale
Standard Error 1.071
|
44.806 Score on a scale
Standard Error 2.548
|
|
Change in Mental Health
3 months
|
45.347 Score on a scale
Standard Error 1.037
|
48.249 Score on a scale
Standard Error 1.531
|
46.926 Score on a scale
Standard Error 1.095
|
48.703 Score on a scale
Standard Error 3.139
|
|
Change in Mental Health
12 months
|
47.082 Score on a scale
Standard Error 1.082
|
47.308 Score on a scale
Standard Error 1.37
|
47.58 Score on a scale
Standard Error 1.066
|
40.085 Score on a scale
Standard Error 4.352
|
Adverse Events
Blood Test Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Brochure Group (Usual Care)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Blood Test Group
n=253 participants at risk
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.
|
Brochure Group (Usual Care)
n=62 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.79%
2/253 • Number of events 2 • Adverse events are reported for the full year of participation of each individual.
Adverse events information was collected from participants if they reported events during phone correspondence with a Research Assistant related to the brief intervention, 2-week, 3-month, and 12-month surveys.
|
0.00%
0/62 • Adverse events are reported for the full year of participation of each individual.
Adverse events information was collected from participants if they reported events during phone correspondence with a Research Assistant related to the brief intervention, 2-week, 3-month, and 12-month surveys.
|
|
Respiratory, thoracic and mediastinal disorders
Self-report of cold/flu/sinus infection
|
0.40%
1/253 • Number of events 1 • Adverse events are reported for the full year of participation of each individual.
Adverse events information was collected from participants if they reported events during phone correspondence with a Research Assistant related to the brief intervention, 2-week, 3-month, and 12-month surveys.
|
0.00%
0/62 • Adverse events are reported for the full year of participation of each individual.
Adverse events information was collected from participants if they reported events during phone correspondence with a Research Assistant related to the brief intervention, 2-week, 3-month, and 12-month surveys.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diagnosis of cancer
|
0.00%
0/253 • Adverse events are reported for the full year of participation of each individual.
Adverse events information was collected from participants if they reported events during phone correspondence with a Research Assistant related to the brief intervention, 2-week, 3-month, and 12-month surveys.
|
1.6%
1/62 • Number of events 1 • Adverse events are reported for the full year of participation of each individual.
Adverse events information was collected from participants if they reported events during phone correspondence with a Research Assistant related to the brief intervention, 2-week, 3-month, and 12-month surveys.
|
|
Psychiatric disorders
Serious depression
|
0.40%
1/253 • Number of events 1 • Adverse events are reported for the full year of participation of each individual.
Adverse events information was collected from participants if they reported events during phone correspondence with a Research Assistant related to the brief intervention, 2-week, 3-month, and 12-month surveys.
|
0.00%
0/62 • Adverse events are reported for the full year of participation of each individual.
Adverse events information was collected from participants if they reported events during phone correspondence with a Research Assistant related to the brief intervention, 2-week, 3-month, and 12-month surveys.
|
Additional Information
Jeffrey Kullgren, MD, MS, MPH - Principal Investigator
VA Center for Clinical Management Research
Phone: (734) 845-3502
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place