Prediabetic State
Conditions
Keywords
lifestyle, patient health record, Veterans, prediabetes
Brief summary
This study was a pilot 3-month clinical trial that investigated the feasibility, effectiveness, and acceptability of using the Track Health function of the Veterans Health Administration's patient health record for effecting a more positive physical activity (PA) and dietary intake lifestyle in a sample of 38 overweight and obese Veterans with prediabetes. Baseline and three-month post-intervention outcomes were measured in two main domains: objective (e.g., weight) and subjective (e.g., self-efficacy).
Detailed description
This was a pilot clinical trial that used a single-group design to test the feasibility, effectiveness, and acceptability of using the Track Health (TH) function of My HealtheVet, the VA's patient health record (PHR), as a tool for effecting a more positive physical activity (PA) and dietary intake lifestyle in overweight and obese Veterans with prediabetes. Baseline and three-month post-intervention outcomes were measured in two main domains: objective (PA as measured by an accelerometer, diet, weight, abdominal circumference, BMI, and blood pressure) and subjective (self-efficacy, intent to adhere to lifestyle change, and patient activation). Assessments, including screening on inclusion and exclusion criteria, physiological measurements, administration of questionnaires, and training on use of two critical features of the TH function--the use of Journals to enter dietary and PA data and the use of Vitals + Readings to enter weight and track physiological measures--took place place across four visits to the study site, which was the Veterans Administration Medical Center in Miami. The investigators hypothesized that this PHR-based intervention would demonstrate improvements and increases, respectively in the objective and subjective domain measures. The investigators also hypothesized that engagement by study participants with MHV would be demonstrated through meeting target criteria regarding making entries into this PHR's TH function, and that participants would be satisfied with the intervention.
Interventions
BEHAVIORALpatient health record
The study intervention involved the provision to study participants of targeted instruction and practice on use of two features of the Track Health (TH) function of the VA's patient health record (PHR) known as My HealthyVet (MHV) -- Journals and Vitals + Readings -- as a basis for promoting positive physical activity (PA) and dietary lifestyles. Seven interactive multimedia instructional modules were developed by the study team. These modules demonstrated on a computer screen how to enter PA and diet information into the Journals feature; how to add weight data into the Vitals + Readings feature; how to view these and other measures in tabular and graphical formats over different time frames; and the concept of possible cause-effect links between behavioral lifestyle and physiological outcome data. Participants were directed to enter food intake, PA, and weight information a specified number of times per week over the 3-month study period.
Sponsors
Miami VA Healthcare System
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veterans with diagnosis of prediabetes (HbA1c 5.7-6.4%, fasting plasma glucose 100-125 mg/dL or oral glucose tolerance test 140-199 mg/dL) * English speaking * Access to the Internet * Body mass index (BMI) of 25-42 kg/m and a sedentary lifestyle (not being physically active three days per week for 20 minutes each time for the previous six months and not performing regular resistance exercise) * Able to engage in a regular program of mild-to-moderate intensity physical activity but were not currently following a weight loss diet or participating in an intervention trial
Exclusion criteria
* Cognitively impaired (Mini-Cog greater than or equal to 3) * Depressed (PHQ-2 less than or equal to 3) * Vision or hearing disorders * Have been diagnosed with diabetes mellitus, uncontrolled hypertension, or cardiovascular disease * Currently pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic and Diastolic Blood Pressure | baseline, 3 months | — |
| Change From Baseline Weight | Baseline, 3 months | measured in lbs. |
| Body Mass Index | baseline, 3 months | Measured in kg/m\^2 |
| Change From Baseline Abdominal Circumference | baseline, 3 months | measured in inches |
| Change From Baseline Energy Expenditure | baseline, 3 months | measured in kcal using an accelerometer |
| Change From Baseline Dietary Intake | baseline, 3 months | 24-hour dietary recall; the Nutrition Data System for Research used to compute kcal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Diet Self-efficacy | baseline, 3 months | a single 7-point item questionnaire (confidence in one's ability to adhere to a healthy diet). Scale range: 1 - 7. Higher numbers indicate less self-efficacy. |
| Change in Intent to Perform Physical Activity | baseline, 3 months | A single 7-point item, ranging from 1 - 7, with lower values indicating increased intent to perform physical activity |
| Change in Intent to Adhere to Diet | baseline, 3 months | A single 7-point item, ranging from 1-7. Lower scores indicate an increased intent to adhere to diet |
| Change in Patient Activation | baseline, 3 months | A 22-item scale that captures various domains of patient activation; scale range: 0 - 100, higher scores indicate greater activation |
| Change From Baseline Physical Activity Self-efficacy | baseline, 3 months | an 18-item exercise self-efficacy questionnaire (confidence in one's ability to exercise) exercises); scale range: 0 - 100. Higher scores indicate increased self-efficacy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient Health Record The study intervention involved the provision to study participants of targeted instruction and practice on use of the Track Health function of the VA's patient health record known as My HealthyVet.
Patient health record: The study intervention involved the provision to study participants of targeted instruction and practice on use of two features of the Track Health (TH) function of the VA's patient health record (PHR) known as My HealthyVet (MHV) -- Journals and Vitals + Readings -- for promoting positive physical activity (PA) and dietary lifestyles. Seven interactive multimedia instructional modules were developed by the study team. These modules demonstrated on a computer screen how to enter PA and diet information into the Journals feature; how to add weight data into the Vitals + Readings feature; how to view these and other measures in tabular and graphical formats over different time frames; and the concept of possible cause-effect links between behavioral lifestyle | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 9 |
Baseline characteristics
| Characteristic | Patient Health Record |
|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 7.7 |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Body Mass Index
Measured in kg/m\^2
Time frame: baseline, 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Health Record | Body Mass Index | baseline | 33.6 kg/m^2 | Standard Deviation 3.9 |
| Patient Health Record | Body Mass Index | 3 months | 33.4 kg/m^2 | Standard Deviation 3.9 |
Primary
Change From Baseline Abdominal Circumference
measured in inches
Time frame: baseline, 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Health Record | Change From Baseline Abdominal Circumference | baseline | 44.2 inches | Standard Deviation 5 |
| Patient Health Record | Change From Baseline Abdominal Circumference | 3 months | 43.5 inches | Standard Deviation 4.9 |
p-value: 0.007t-test, 2 sided
Primary
Change From Baseline Dietary Intake
24-hour dietary recall; the Nutrition Data System for Research used to compute kcal
Time frame: baseline, 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Health Record | Change From Baseline Dietary Intake | baseline | 1612.2 kcal | Standard Deviation 598.3 |
| Patient Health Record | Change From Baseline Dietary Intake | 3 months | 1525.0 kcal | Standard Deviation 777.3 |
Primary
Change From Baseline Energy Expenditure
measured in kcal using an accelerometer
Time frame: baseline, 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Health Record | Change From Baseline Energy Expenditure | baseline | 435.2 kcal | Standard Deviation 208.5 |
| Patient Health Record | Change From Baseline Energy Expenditure | 3 months | 483.8 kcal | Standard Deviation 221 |
p-value: 0.026t-test, 2 sided
Primary
Change From Baseline Weight
measured in lbs.
Time frame: Baseline, 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Health Record | Change From Baseline Weight | baseline | 225.0 lbs. | Standard Deviation 36.3 |
| Patient Health Record | Change From Baseline Weight | 3 months | 222.1 lbs. | Standard Deviation 36 |
p-value: 0.003Wilcoxon (Mann-Whitney)
Primary
Systolic and Diastolic Blood Pressure
Time frame: baseline, 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Health Record | Systolic and Diastolic Blood Pressure | systolic bp, baseline | 131.5 mmHg | Standard Deviation 16.6 |
| Patient Health Record | Systolic and Diastolic Blood Pressure | systolic bp, 3 months | 124.0 mmHg | Standard Deviation 13.7 |
| Patient Health Record | Systolic and Diastolic Blood Pressure | diastolic bp, baseline | 89.2 mmHg | Standard Deviation 10.9 |
| Patient Health Record | Systolic and Diastolic Blood Pressure | diastolic bp, 3 moths | 81.0 mmHg | Standard Deviation 12.6 |
p-value: 0.003t-test, 2 sided
Comparison: diastolic blood pressurep-value: 0.001t-test, 2 sided
Secondary
Change From Baseline Diet Self-efficacy
a single 7-point item questionnaire (confidence in one's ability to adhere to a healthy diet). Scale range: 1 - 7. Higher numbers indicate less self-efficacy.
Time frame: baseline, 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Health Record | Change From Baseline Diet Self-efficacy | baseline | 1.9 units on a scale | Standard Deviation 1.2 |
| Patient Health Record | Change From Baseline Diet Self-efficacy | 3 months | 2.4 units on a scale | Standard Deviation 1.4 |
p-value: 0.019Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline Physical Activity Self-efficacy
an 18-item exercise self-efficacy questionnaire (confidence in one's ability to exercise) exercises); scale range: 0 - 100. Higher scores indicate increased self-efficacy.
Time frame: baseline, 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Health Record | Change From Baseline Physical Activity Self-efficacy | baseline | 57.4 units on a scale | Standard Deviation 16.8 |
| Patient Health Record | Change From Baseline Physical Activity Self-efficacy | 3 months | 56.4 units on a scale | Standard Deviation 17.5 |
Secondary
Change in Intent to Adhere to Diet
A single 7-point item, ranging from 1-7. Lower scores indicate an increased intent to adhere to diet
Time frame: baseline, 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Health Record | Change in Intent to Adhere to Diet | baseline | 2.0 units on a scale | Standard Deviation 1.2 |
| Patient Health Record | Change in Intent to Adhere to Diet | 3 months | 2.2 units on a scale | Standard Deviation 1.3 |
Secondary
Change in Intent to Perform Physical Activity
A single 7-point item, ranging from 1 - 7, with lower values indicating increased intent to perform physical activity
Time frame: baseline, 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Health Record | Change in Intent to Perform Physical Activity | baseline | 2.1 units on a scale | Standard Deviation 1.3 |
| Patient Health Record | Change in Intent to Perform Physical Activity | 3 months | 2.6 units on a scale | Standard Deviation 1.5 |
Secondary
Change in Patient Activation
A 22-item scale that captures various domains of patient activation; scale range: 0 - 100, higher scores indicate greater activation
Time frame: baseline, 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Health Record | Change in Patient Activation | baseline | 67.5 units on a scale | Standard Deviation 12.3 |
| Patient Health Record | Change in Patient Activation | 3 months | 67.8 units on a scale | Standard Deviation 14.5 |