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

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ClinicalTrials.gov Identifier: NCT04021472
Recruitment Status : Not yet recruiting
First Posted : July 16, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
In this trial, the investigators will examine whether text messages sent to Veterans will help support in meeting nutrition or physical activity health goals. One group will get the text messages only and a second group will receive the text messages combined with two calls from a Veteran peer health coach who will support participants in meeting goals. The investigators will therefore examine whether or not the addition of a health coach promotes goal-related health outcomes.

Condition or disease Intervention/treatment Phase
Chronic Disease Prevention Behavioral: Text message Behavioral: Veteran peer health coaching Early Phase 1

Detailed Description:
Using the VET-C cohort, the investigators are preparing to conduct a two-group randomized pilot trial evaluating Veterans who receive automated text messaging (comparison group) compared to those who receive automated text messaging plus health coaching support (intervention group). Completion of this pilot trial will provide preliminary insights regarding efficacy and feasibility and help understand whether and how health coaching enhances the effect of an automated texting system on outcomes. It will also provide data on how best to incorporate health coaching into the adoption and use of connected care technologies for health behavior and behavior change.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-group randomized trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluate Health Coaching Support in Technology-based Interventions for Goal Setting (PEC 15-470)
Estimated Study Start Date : August 26, 2019
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Text message + Veteran peer health coach
Participants receive text messages about their health as well as Veteran peer health coaching
Behavioral: Text message
Two months of daily text messages to support meeting a health goal

Behavioral: Veteran peer health coaching
Two telephone calls from a Veteran peer health coach to support meeting a health goal

Active Comparator: Text message
Participants receive text messages about their health
Behavioral: Text message
Two months of daily text messages to support meeting a health goal




Primary Outcome Measures :
  1. Self-efficacy: Healthful eating via Revised Eating Self-Efficacy Scale (ESES-R) [ Time Frame: Change from Baseline to 2 months ]
    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.

  2. Goal commitment: Healthful eating via the Hollenbeck, Williams, and Klein Goal Commitment Scale [ Time Frame: Change from Baseline to 2 months ]
    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.

  3. Self-efficacy: Physical activity via the Self-efficacy for Exercise Behaviors Scale [ Time Frame: Change from Baseline to 2 months ]
    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.

  4. Goal commitment: Physical activity via the Hollenbeck, Williams, and Klein Goal Commitment Scale [ Time Frame: Change from Baseline to 2 months ]
    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 :
  1. Health confidence: the Health Confidence Score [ Time Frame: Change from Baseline to 2 months ]
    Self-reported confidence in patient engagement. Health Confidence. Range: 0-12; higher values represent a better outcome.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04021472


Contacts
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Contact: Lisa M Quintiliani, PhD (781) 687-2000 Lisa.Quintiliani@va.gov
Contact: Lorilei M Richardson, MS MS PhD (781) 687-4032 lorilei.richardson@va.gov

Locations
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United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA Not yet recruiting
Bedford, Massachusetts, United States, 01730
Contact: Lisa M Quintiliani, PhD    (781) 687-2000    Lisa.Quintiliani@va.gov   
Principal Investigator: Lisa M. Quintiliani, PhD         
Principal Investigator: Timothy Patrick Hogan, PhD MS BS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Timothy Patrick Hogan, PhD MS BS Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Principal Investigator: Lisa M. Quintiliani, PhD Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04021472     History of Changes
Other Study ID Numbers: PEX 19-002
PEC 15-470 ( Other Grant/Funding Number: Office of Connected Care )
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by VA Office of Research and Development:
Disease prevention
Peer health coaching
Digital health
Text messaging

Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes