Back to resultsEvaluate Health Coaching Support in Technology-based Interventions for Meeting Health Goals (Coaching)
Primary Purpose
Chronic Disease Prevention
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text message
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Disease Prevention focused on measuring Disease prevention, Digital health, Text messaging
Eligibility Criteria
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
Sites / Locations
- VA Bedford HealthCare System, Bedford, MA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Text message
Arm Description
Participants receive text messages about healthy eating or physical activity.
Outcomes
Primary Outcome Measures
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.
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.
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.
Goal commitment: Physical activity via the Hollenbeck, Williams, and Klein Goal Commitment Scale
Self-reported commitment to healthful diet and physical activity goals. Goal commitment - Physical activity via the Hollenbeck, Williams, and Klein Goal Commitment Scale. Range: 1-5; higher values represent a better outcome.
Secondary Outcome Measures
Health confidence: the Health Confidence Score
Self-reported confidence in patient engagement. Health Confidence. Range: 0-12; higher values represent a better outcome.
Full Information
NCT ID
NCT04021472
First Posted
June 27, 2019
Last Updated
December 29, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04021472
Brief Title
Evaluate Health Coaching Support in Technology-based Interventions for Meeting Health Goals
Acronym
Coaching
Official Title
Evaluate Health Coaching Support in Technology-based Interventions for Goal Setting (PEC 15-470)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease Prevention
Keywords
Disease prevention, Digital health, Text messaging
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One-group trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Text message
Arm Type
Experimental
Arm Description
Participants receive text messages about healthy eating or physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Text message
Intervention Description
Two months of daily text messages to support meeting a health goal
Primary Outcome Measure Information:
Title
Self-efficacy: Healthful eating via Revised Eating Self-Efficacy Scale (ESES-R)
Description
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.
Time Frame
Change from Baseline to 2 months
Title
Goal commitment: Healthful eating via the Hollenbeck, Williams, and Klein Goal Commitment Scale
Description
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.
Time Frame
Change from Baseline to 2 months
Title
Self-efficacy: Physical activity via the Self-efficacy for Exercise Behaviors Scale
Description
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.
Time Frame
Change from Baseline to 2 months
Title
Goal commitment: Physical activity via the Hollenbeck, Williams, and Klein Goal Commitment Scale
Description
Self-reported commitment to healthful diet and physical activity goals. Goal commitment - Physical activity via the Hollenbeck, Williams, and Klein Goal Commitment Scale. Range: 1-5; higher values represent a better outcome.
Time Frame
Change from Baseline to 2 months
Secondary Outcome Measure Information:
Title
Health confidence: the Health Confidence Score
Description
Self-reported confidence in patient engagement. Health Confidence. Range: 0-12; higher values represent a better outcome.
Time Frame
Change from Baseline to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Patrick Hogan, PhD MS BS
Organizational Affiliation
VA Bedford HealthCare System, Bedford, MA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa M. Quintiliani, PhD
Organizational Affiliation
VA Bedford HealthCare System, Bedford, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Bedford HealthCare System, Bedford, MA
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluate Health Coaching Support in Technology-based Interventions for Meeting Health Goals
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