Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04021472
Other study ID # PEX 19-002
Secondary ID PEC 15-470
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date December 31, 2021

Study information

Verified date April 2024
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This was a pilot evaluation conducted to test procedures for a possible future trial and provide preliminary insights regarding whether text messages sent to Veterans could help support nutrition and/or physical activity health goals. For the purposes of the pilot, the goal was to enroll one participant.


Description:

The investigators prepared procedures for a one-group pilot intended to evaluate the delivery of automated text messages to Veterans. Completion of this pilot will provide preliminary insights regarding the delivering automated text messages focused on nutrition and/or physical activity health goals, and potential impacts on outcomes like self-efficacy, goal commitment, and health confidence.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient at designated VA site - Ownership of a cellular phone - Over age 18 - Pre-screened by their primary care physician for study inclusion for medical contraindication to physical activity and diet change Exclusion Criteria: - Patient outside designated VA site - Non-ownership of a cellular phone - Under age 18 - Not pre-screened by their primary care physician for study inclusion for medical contraindication to physical activity and diet change or deemed ineligible to participate by primary care physician

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Text message
Two months of daily text messages to support meeting a health goal

Locations

Country Name City State
United States VA Bedford HealthCare System, Bedford, MA Bedford Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-efficacy: Healthful Eating Via Revised Eating Self-Efficacy Scale (ESES-R) Self-reported confidence in performing healthful diet and physical activity behaviors. Self-efficacy - Healthful eating via Revised Eating Self-Efficacy Scale (ESES-R). Range: 1-10; higher values represent a better outcome. Change from Baseline to 2 months
Primary Goal Commitment: Healthful Eating Via the Hollenbeck, Williams, and Klein Goal Commitment Scale Self-reported commitment to healthful diet and physical activity goals. Goal commitment - Healthful eating via the Hollenbeck, Williams, and Klein Goal Commitment Scale. Range: 1-5; higher values represent a better outcome. Change from Baseline to 2 months
Primary Self-efficacy: Physical Activity Via the Self-efficacy for Exercise Behaviors Scale Self-reported confidence in performing healthful diet and physical activity behaviors. Self-efficacy - Physical activity via the Self-efficacy for Exercise Behaviors Scale. Range: 1-5; higher values represent a better outcome. Change from Baseline to 2 months
Primary Goal Commitment - Physical Activity Via the Hollenbeck, Williams, and Klein Physical Activity Scale Self-reported commitment to healthful diet and physical activity goals. The determination to attempt a physical activity-related goal and consistently pursue it over time. Goal commitment - Physical activity via the Hollenbeck, Williams, and Klein Goal Commitment Scale. Range: 1-5; higher values represent a better outcome. Baseline
Secondary Health Confidence: the Health Confidence Score Self-reported confidence in patient engagement. Health Confidence. Range: 0-12; higher values represent a better outcome. Change from Baseline to 2 months
See also
  Status Clinical Trial Phase
Completed NCT06358781 - A Dose-response Study to Validate the Biomarkers for Whole Grain Dietary Intake N/A