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Completed

NCT Number: NCT02921425

Use of Track Health Function of the MyHealthevet Personal Health Record

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).

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

patient health record

Behavioral

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.

Primary outcomes

  1. Change From Baseline Weight

    Time frame: Baseline, 3 months

    measured in lbs.

  2. Body Mass Index

    Time frame: baseline, 3 months

    Measured in kg/m^2

  3. Change From Baseline Abdominal Circumference

    Time frame: baseline, 3 months

    measured in inches

  4. Change From Baseline Energy Expenditure

    Time frame: baseline, 3 months

    measured in kcal using an accelerometer

  5. Change From Baseline Dietary Intake

    Time frame: baseline, 3 months

    24-hour dietary recall; the Nutrition Data System for Research used to compute kcal

  6. Systolic and Diastolic Blood Pressure

    Time frame: baseline, 3 months

Secondary outcomes

  1. Change From Baseline Physical Activity Self-efficacy

    Time frame: 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.

  2. Change From Baseline Diet Self-efficacy

    Time frame: 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.

  3. Change in Intent to Perform Physical Activity

    Time frame: baseline, 3 months

    A single 7-point item, ranging from 1 - 7, with lower values indicating increased intent to perform physical activity

  4. Change in Intent to Adhere to Diet

    Time frame: baseline, 3 months

    A single 7-point item, ranging from 1-7. Lower scores indicate an increased intent to adhere to diet

  5. Change in Patient Activation

    Time frame: baseline, 3 months

    A 22-item scale that captures various domains of patient activation; scale range: 0 - 100, higher scores indicate greater activation

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Miami VA Healthcare System

Registry information

Official study title

Use of the Track Health Function of the MyHealtheVet Personal Health Record

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 3, 2016
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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