NCT04021472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

April 5, 2024

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

2.7 years

First QC Date

June 27, 2019

Results QC Date

August 2, 2023

Last Update Submit

April 2, 2024

Conditions

Keywords

Disease preventionDigital healthText messaging

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Health Confidence: the Health Confidence Score

    Change from Baseline to 2 months

Study Arms (1)

Text message

EXPERIMENTAL

Participants receive text messages about healthy eating or physical activity.

Behavioral: Text message

Interventions

Text messageBEHAVIORAL

Two months of daily text messages to support meeting a health goal

Text message

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient at designated VA site
  • Ownership of a cellular phone
  • Over age 18

You may not qualify if:

  • Patient outside designated VA site
  • Non-ownership of a cellular phone
  • Under age 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730, United States

Location

Results Point of Contact

Title
Timothy P. Hogan
Organization
VA Bedford Healthcare System

Study Officials

  • Timothy Patrick Hogan, PhD MS BS

    VA Bedford HealthCare System, Bedford, MA

    PRINCIPAL INVESTIGATOR
  • Lisa M. Quintiliani, PhD

    VA Bedford HealthCare System, Bedford, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: One-group trial
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 16, 2019

Study Start

May 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 5, 2024

Results First Posted

April 5, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations