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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04021472
Acronym
Coaching
Enrollment
1
Registered
2019-07-16
Start date
2019-05-01
Completion date
2021-12-31
Last updated
2024-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease Prevention

Keywords

Disease prevention, Digital health, Text messaging

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.

Interventions

BEHAVIORALText message

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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

One-group trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Self-efficacy: Healthful Eating Via Revised Eating Self-Efficacy Scale (ESES-R)Change from Baseline to 2 monthsSelf-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 ScaleChange from Baseline to 2 monthsSelf-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 ScaleChange from Baseline to 2 monthsSelf-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 Physical Activity ScaleBaselineSelf-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.

Secondary

MeasureTime frameDescription
Health Confidence: the Health Confidence ScoreChange from Baseline to 2 monthsSelf-reported confidence in patient engagement. Health Confidence. Range: 0-12; higher values represent a better outcome.

Countries

United States

Participant flow

Participants by arm

ArmCount
Text Message
Participants receive text messages about healthy eating or physical activity. Text message: Two months of daily text messages to support meeting a health goal
1
Total1

Baseline characteristics

CharacteristicText Message
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
1 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous81 years
STANDARD_DEVIATION 0
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
1 Participants
Region of Enrollment
United States
1 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
1 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 1
other
Total, other adverse events
0 / 1
serious
Total, serious adverse events
0 / 1

Outcome results

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.

Time frame: Change from Baseline to 2 months

ArmMeasureValue (NUMBER)
Text MessageGoal Commitment: Healthful Eating Via the Hollenbeck, Williams, and Klein Goal Commitment Scale-0.2 score on a scale
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.

Time frame: Baseline

Population: This scale was not administered at 2 month follow-up

ArmMeasureValue (NUMBER)
Text MessageGoal Commitment - Physical Activity Via the Hollenbeck, Williams, and Klein Physical Activity Scale4.2 score on a scale
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.

Time frame: Change from Baseline to 2 months

ArmMeasureValue (NUMBER)
Text MessageSelf-efficacy: Healthful Eating Via Revised Eating Self-Efficacy Scale (ESES-R)2.3 score on a scale
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.

Time frame: Change from Baseline to 2 months

ArmMeasureValue (NUMBER)
Text MessageSelf-efficacy: Physical Activity Via the Self-efficacy for Exercise Behaviors Scale2.5 score on a scale
Secondary

Health Confidence: the Health Confidence Score

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

ArmMeasureValue (NUMBER)
Text MessageHealth Confidence: the Health Confidence Score0.75 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026