Chronic Disease PreventionCoachingNCT04021472

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

A study testing Text message in people with Chronic Disease Prevention, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Chronic Disease Prevention
What is being tested?: Text message
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: 1 May 2019to 31 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730

Other trials in United States

About this study

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

Read the 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.

Conditions: Chronic Disease Prevention
Being tested: Text message
Keywords: Disease prevention, Digital health, Text messaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04021472
Study group	Role	What they receive
Text message	Experimental	Participants receive text messages about healthy eating or physical activity. Receives: Behavioral: Text message

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline

Secondary outcomes (1)

Health Confidence: the Health Confidence Score
Self-reported confidence in patient engagement. Health Confidence. Range: 0-12; higher values represent a better outcome.
Measured: Change from Baseline to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201931 Dec 2021

First posted16 Jul 2019
Study start1 May 2019
Primary completion31 Dec 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Disease PreventionStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: One-group trial
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04021472
Sponsor's protocol ID: PEX 19-002
Other IDs: PEC 15-470
Acronym: Coaching
Status last verified: Apr 2024
First submitted: 27 Jun 2019
Last updated: 5 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
Migraine
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Active, not recruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Migraine
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant
Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia

All Chronic Disease Prevention trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluate Health Coaching Support in Technology-based Interventions for Goal Setting (PEC 15-470)
ClinicalTrials.gov ID: NCT04021472
Acronym / sponsor ID: Coaching / PEX 19-002
Conditions: Chronic Disease Prevention
Keywords: Disease prevention, Digital health, Text messaging
Study type: Interventional
Recruitment status: Completed
Enrolment: 1 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 May 2019 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 16 Jul 2019 (actual)
Results: Posted 5 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: One-group trial

Arm	Type	Receives
Text message	Experimental	Behavioral: Text messageParticipants receive text messages about healthy eating or physical activity.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Text messageTwo months of daily text messages to support meeting a health goal	Behavioural	Text message

Primary outcome

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.
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.
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.
Goal Commitment - Physical Activity Via the Hollenbeck, Williams, and Klein Physical Activity Scale
Time frame: Baseline
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.

1 secondary outcome

Health Confidence: the Health Confidence Score
Time frame: Change from Baseline to 2 months

Results and safety

Results posted to the registry on 5 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Text Message	1	1

Primary outcome: Self-efficacy: Healthful Eating Via Revised Eating Self-Efficacy Scale (ESES-R)

Time frame: Change from Baseline to 2 months. Number. Unit: score on a scale

Measure	Text Message n = 1
Value	2.3

Primary outcome: Goal Commitment: Healthful Eating Via the Hollenbeck, Williams, and Klein Goal Commitment Scale

Time frame: Change from Baseline to 2 months. Number. Unit: score on a scale

Measure	Text Message n = 1
Value	-0.2

Primary outcome: Self-efficacy: Physical Activity Via the Self-efficacy for Exercise Behaviors Scale

Time frame: Change from Baseline to 2 months. Number. Unit: score on a scale

Measure	Text Message n = 1
Value	2.5

Primary outcome: Goal Commitment - Physical Activity Via the Hollenbeck, Williams, and Klein Physical Activity Scale

Time frame: Baseline. Number. Unit: score on a scale

Measure	Text Message n = 1
Value	4.2

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Data were collected over the course of 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Text Message	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Chronic Disease Prevention

Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
Migraine
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Active, not recruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Migraine
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant
Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Timothy Patrick Hogan, PhD MS BS principal investigator

VA Bedford HealthCare System, Bedford, MA

Lisa M. Quintiliani, PhD principal investigator

VA Bedford HealthCare System, Bedford, MA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Text message in people with Chronic Disease Prevention, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-efficacy: Healthful Eating Via Revised Eating Self-Efficacy Scale (ESES-R) (time frame: Change from Baseline to 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04021472.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.