Evaluate Health Coaching Support in Technology-based Interventions for Meeting Health Goals (Coaching)

Evaluate Health Coaching Support in Technology-based Interventions for Goal Setting (PEC 15-470)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease Prevention
• Intervention / Treatment: Behavioral: Text message

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Bedford, Massachusetts, United States, 01730
      • VA Bedford HealthCare System, Bedford, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Text message; Participants receive text messages about healthy eating or physical activity.	Behavioral: Text message; Two months of daily text messages to support meeting a health goal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Timothy Patrick Hogan, PhD MS BS, VA Bedford HealthCare System, Bedford, MA; Principal Investigator: Lisa M. Quintiliani, PhD, VA Bedford HealthCare System, Bedford, MA

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Text messaging; Digital health; Disease prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: PEX 19-002; PEC 15-470 (Other Grant/Funding Number: Office of Connected Care)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No