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PREVENT Tool Study: Late Effects Clinic

Addressing Social Determinants of Health During Clinical Care Visits to Promote Equitable Behavior Change and PREVENT Cardiovascular Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04530825
Enrollment
65
Registered
2020-08-28
Start date
2021-02-10
Completion date
2022-02-14
Last updated
2023-04-25

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

Conditions

Cardiovascular Disease, Childhood Obesity

Brief summary

The purpose of this study is to test the feasibility of a novel, Health Information Technology behavior change tool in a single clinic setting. The PREVENT tool is the first electronic health record (EHR)-compatible tool that both tailors evidence-based behavior change strategies and incorporates community-level data specific to each patient into routine care. The central hypothesis is that PREVENT will improve patient's attitudes towards behavior change recommendations, increase adherence to recommended behavior change and improve cardiovascular health. Fifty adolescents will be randomized to intervention or wait-list, routine care control to assess the preliminary effectiveness of PREVENT. Qualitative and quantitative methods will be used among patients, parents and providers to examine barriers to current and future implementation of the PREVENT tool to inform adoption and maintenance.

Interventions

OTHERWait-List Control

-Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool

-PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese adolescent patients at the point of care. PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help providers link patients to resources in their community.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 19 Years
Healthy volunteers
No

Inclusion criteria

Patient Eligibility Criteria: * Adolescents 12 to 19 years * Prior diagnosis of pediatric cancer (diagnosed \<21 years of age) * Not receiving active therapy for their cancer * Receiving care from the Pediatric Hematology/Oncology staff and physicians at St. Louis Children's Hospital or the St. Louis Children's Specialty Care Center (CSCC) * At risk for poor cardiovascular health (CVH) (BMI greater than or equal to 85th percentile) Provider Eligibility Criteria -All providers and staff (physicians, nurses, clinic staff, clinical research associates) in the Pediatric Hematology/Oncology program at St. Louis Children's Hospital and the CSCC Parent Eligibility Criteria -A parent or legal guardian of a study participant. The parent or legal guardian must have been present at the clinic visit in which the PREVENT tool was administered to the study participant.

Design outcomes

Primary

MeasureTime frameDescription
Mean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) SurveyAt baseline and 3-months* Physical activity will be measured using a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). The participant will be instructed to wear the accelerometer on an elasticized belt, on the left mid-axillary line. The Actigraph is one of the most common accelerometers used for scientific purposes. Participants will be encouraged to wear the accelerometer 24-hours per day for at least 7-days, including 2 weekend days. Participants completed a brief Health Behavior & Attitudes Survey using questions from the International Physical Activity Questionnaire Mean changes from baseline and 3-month follow-up were calculated as the follow-up measure minus the baseline measure, averaged across the intervention groups. * Note: Actigraph measure was dropped due to university mail distribution delays during the remote work period of the COVID-19 pandemic. Self-reported change in minutes of physical activity became the primary outcome.
Mean Change in Minutes of Vigorous Physical Activity Per Week (From Self Report) SurveyAt baseline and 3-months* Physical activity will be measured using a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). The participant will be instructed to wear the accelerometer on an elasticized belt, on the left mid-axillary line. The Actigraph is one of the most common accelerometers used for scientific purposes. Participants will be encouraged to wear the accelerometer 24-hours per day for at least 7-days, including 2 weekend days. Participants completed a brief Health Behavior & Attitudes Survey using questions from the International Physical Activity Questionnaire Mean changes from baseline and 3-month follow-up were calculated as the follow-up measure minus the baseline measure, averaged across the intervention groups. * Note: Actigraph measure was dropped due to university mail distribution delays during the remote work period of the COVID-19 pandemic. Self-reported change in minutes of physical activity became the primary outcome.
Mean Change in Number of Food Intake Behaviors MetAt baseline and 3-monthsPatient-reported food intake behaviors (fruit and vegetable intake, whole grains, sugar-sweetened beverages and snacking behaviors) are collected using a brief Health Behavior & Attitudes Survey. Responses are dichotomized into a binary yes (1)/no (0) score indicating whether or not the patient is meeting the food intake recommendation for each food group. The total number of food intake behaviors are scored on a 5 item scale (range 0-5), maximum improvement in number of behaviors=5. Mean changes from baseline and 3-month follow-up were calculated as the follow-up measure minus the baseline measure, averaged across the intervention groups.
Provider's Satisfaction of PREVENT Tool: Survey3-monthsA survey (24-questions) containing validated subscales assessed provider's satisfaction with the PREVENT tool on subscales assessing acceptability, feasibility, and appropriateness of the tool, and satisfaction with specific components of the tool. Items were scored on a 5-point Likert scale with a higher score indicating greater satisfaction. Subscales were summed to generate the average across all questions (range 1-5) and was reported as overall satisfaction.
Fidelity of PREVENT Tool Implementation0-3 monthsFidelity will be measured using direct observation of patient-provider interactions while using the PREVENT tool. A direct observation checklist will be used by the observer to determine the number of interactions with the PREVENT tool that were implemented as intended.

Secondary

MeasureTime frameDescription
Impact of PREVENT Tool on Mean Change in Patient's Body Mass Index (BMI)At baseline and 3-monthsCollected from patient's medical record. BMI z-score is a standardized calculation accounting age and sex using the Centers for Disease Control and Prevention Growth Charts. A z-score represents the standard deviation from the population mean. A z-score of zero represents the population mean. Mean change in BMI z-score was calculated by subtracting the baseline mean from the follow-up mean for each intervention group. A decrease in z-score is a favorable outcome.
Impact of PREVENT Tool on Patient's Systolic and Diastolic Blood PressureAt baseline and 3-monthsCollected from patient's medical record. Blood pressure is measured in mmHg. The mean change was calculated by subtracting the baseline mean from the follow-up mean for each intervention group.
Impact of PREVENT Tool on Patient's CholesterolAt baseline and 3-monthsCollected from patient's medical record
Provider's Motivation for Sustained Use of PREVENT Tool3-monthsA survey (8 questions) assessed provider's intent to change their behavior and continue using PREVENT. Questions were adapted from Legare's CPD Reaction Questionnaire and asked using a 5-point Likert scale (range 1-5). An average of all responses was calculated with a higher score indicating greater motivation for sustained use.
Impact of PREVENT Tool on Patient's Attitudes Toward Behavior ChangeAt baseline and 3-monthsA survey (6-question) administered to patients will assess attitudes toward and readiness for behavior change. Questions are asked using a 5-point Likert scale (range: 0-5) with a higher score indicating more positive attitudes.
Clinic-level Capacity for Sustainability as Measured by Provider Survey3-monthsThe Clinical Sustainability Assessment Tool (CSAT) will assess clinic-level readiness and capacity for sustainability of the PREVENT tool. The CSAT tool will examine organization, financial, regulatory and political factors that may influence sustainability. 10 items scored on a 7-point scale, with higher scores indicating greater capacity for sustainment. The average of the 10 items is reported (range 1-7).
Impact of PREVENT Tool on Patient's Fasting Blood GlucoseAt baseline and 3-monthsCollected from patient's medical record
Maintenance of PREVENT Tool as Measured by Provider Perceptions of Feasibility of the Tool3-monthsQualitative in-depth interview with providers who used the PREVENT tool. Qualitative content analysis methods were used to summarize key themes related to provider perceptions of the tool and ability to use the tool in routine clinical practice.
Maintenance of PREVENT Tool as Measured by Provider Perceptions of Ease of Use of the Tool3-monthsQualitative in-depth interview with providers who used the PREVENT tool. Qualitative content analysis methods were used to summarize key themes related to provider perceptions of the tool and ability to use the tool in routine clinical practice.
Patient's Perceptions of Usability/Acceptability of PREVENT Tool3-monthsSemi-structured interviews with adolescent study participants (n=10).
Parent's Perceptions of Usability/Acceptability of PREVENT Tool3-monthsSemi-structured interviews with parents/guardians (n=10) of study participants.

Countries

United States

Participant flow

Participants by arm

ArmCount
Providers
* All eligible providers were sent questionnaires electronically to their email at baseline and follow-up. Providers were invited to attend a training session to educate them on the PREVENT tool at baseline * A subset of 5-10 providers were recruited via email, at the baseline training, or by using snowball-sampling approach within the clinic to participate in qualitative in-depth interviews
4
Parents
-Semi-structured interviews
28
Patients - Wait-List Control
* Completed questionnaires at baseline (administered electronically or by mail; accelerometers administered by mail). Following baseline measurement, patients were randomized and attended their clinic visit. Follow-up measures were administered immediately following the clinic visit (within 48 hours) and 3-months after the clinic visit electronically and by mail * Up to 10 patients took part in semi-structured interviews * A PREVENT action plan (behavior change prescription, community resources, and education) was provided to the patient via email after the completion of the follow-up measurement.
16
Patients - PREVENT Tool
* Completed questionnaires at baseline (administered electronically or by mail; accelerometers administered by mail). Following baseline measurement, patients were randomized and attended their clinic visit. Follow-up measures were administered immediately following the clinic visit (within 48 hours) and 3-months after the clinic visit electronically and by mail * Up to 10 patients took part in semi-structured interviews * At the clinic visit, the provider used the PREVENT tool to discuss risk and deliver a tailored behavioral change plan inclusive of patient-centered community resources. PREVENT calculates patient's overall risk for developing cardiovascular disease. Physical activity and food intake recommendations are tailored to current weight status and health behaviors using evidence-based recommendations.
12
Total60

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyDid not complete follow-up3000
Overall StudyNo longer eligible on the day of baseline visit0101

Baseline characteristics

CharacteristicTotalProvidersPatients - Wait-List ControlPatients - PREVENT ToolParents
Age, Continuous19.4 years40.5 years16.0 years17.0 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
32 Participants4 Participants16 Participants12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
3 Participants0 Participants1 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
27 Participants3 Participants15 Participants9 Participants
Region of Enrollment
United States
60 participants4 participants16 participants12 participants28 participants
Sex: Female, Male
Female
15 Participants3 Participants6 Participants6 Participants
Sex: Female, Male
Male
17 Participants1 Participants10 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 160 / 12
other
Total, other adverse events
0 / 00 / 00 / 160 / 12
serious
Total, serious adverse events
0 / 00 / 00 / 160 / 12

Outcome results

Primary

Fidelity of PREVENT Tool Implementation

Fidelity will be measured using direct observation of patient-provider interactions while using the PREVENT tool. A direct observation checklist will be used by the observer to determine the number of interactions with the PREVENT tool that were implemented as intended.

Time frame: 0-3 months

Population: Data was not collected on this outcome measure as the study team was unable to consistently observe study visits due to COVID-19 restrictions.

Primary

Mean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) Survey

* Physical activity will be measured using a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). The participant will be instructed to wear the accelerometer on an elasticized belt, on the left mid-axillary line. The Actigraph is one of the most common accelerometers used for scientific purposes. Participants will be encouraged to wear the accelerometer 24-hours per day for at least 7-days, including 2 weekend days. Participants completed a brief Health Behavior & Attitudes Survey using questions from the International Physical Activity Questionnaire Mean changes from baseline and 3-month follow-up were calculated as the follow-up measure minus the baseline measure, averaged across the intervention groups. * Note: Actigraph measure was dropped due to university mail distribution delays during the remote work period of the COVID-19 pandemic. Self-reported change in minutes of physical activity became the primary outcome.

Time frame: At baseline and 3-months

Population: Providers and parents were not evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Patients - Wait-List ControlMean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) Survey43.3 minutes/weekStandard Deviation 341.6
Patients - PREVENT ToolMean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) Survey16.8 minutes/weekStandard Deviation 357.7
Primary

Mean Change in Minutes of Vigorous Physical Activity Per Week (From Self Report) Survey

* Physical activity will be measured using a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). The participant will be instructed to wear the accelerometer on an elasticized belt, on the left mid-axillary line. The Actigraph is one of the most common accelerometers used for scientific purposes. Participants will be encouraged to wear the accelerometer 24-hours per day for at least 7-days, including 2 weekend days. Participants completed a brief Health Behavior & Attitudes Survey using questions from the International Physical Activity Questionnaire Mean changes from baseline and 3-month follow-up were calculated as the follow-up measure minus the baseline measure, averaged across the intervention groups. * Note: Actigraph measure was dropped due to university mail distribution delays during the remote work period of the COVID-19 pandemic. Self-reported change in minutes of physical activity became the primary outcome.

Time frame: At baseline and 3-months

Population: Providers and parents were not evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Patients - Wait-List ControlMean Change in Minutes of Vigorous Physical Activity Per Week (From Self Report) Survey-211.4 minutes/weekStandard Deviation 241.6
Patients - PREVENT ToolMean Change in Minutes of Vigorous Physical Activity Per Week (From Self Report) Survey-1.4 minutes/weekStandard Deviation 109
Primary

Mean Change in Number of Food Intake Behaviors Met

Patient-reported food intake behaviors (fruit and vegetable intake, whole grains, sugar-sweetened beverages and snacking behaviors) are collected using a brief Health Behavior & Attitudes Survey. Responses are dichotomized into a binary yes (1)/no (0) score indicating whether or not the patient is meeting the food intake recommendation for each food group. The total number of food intake behaviors are scored on a 5 item scale (range 0-5), maximum improvement in number of behaviors=5. Mean changes from baseline and 3-month follow-up were calculated as the follow-up measure minus the baseline measure, averaged across the intervention groups.

Time frame: At baseline and 3-months

Population: Providers and parents were not evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Patients - Wait-List ControlMean Change in Number of Food Intake Behaviors Met0.15 score on a 0-5 scaleStandard Deviation 1.1
Patients - PREVENT ToolMean Change in Number of Food Intake Behaviors Met0.78 score on a 0-5 scaleStandard Deviation 1.9
Primary

Provider's Satisfaction of PREVENT Tool: Survey

A survey (24-questions) containing validated subscales assessed provider's satisfaction with the PREVENT tool on subscales assessing acceptability, feasibility, and appropriateness of the tool, and satisfaction with specific components of the tool. Items were scored on a 5-point Likert scale with a higher score indicating greater satisfaction. Subscales were summed to generate the average across all questions (range 1-5) and was reported as overall satisfaction.

Time frame: 3-months

Population: Parents and patients were not evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
ProvidersProvider's Satisfaction of PREVENT Tool: Survey3.61 score on a scaleStandard Deviation 1.1
Secondary

Clinic-level Capacity for Sustainability as Measured by Provider Survey

The Clinical Sustainability Assessment Tool (CSAT) will assess clinic-level readiness and capacity for sustainability of the PREVENT tool. The CSAT tool will examine organization, financial, regulatory and political factors that may influence sustainability. 10 items scored on a 7-point scale, with higher scores indicating greater capacity for sustainment. The average of the 10 items is reported (range 1-7).

Time frame: 3-months

Population: Parents and patients were not evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
ProvidersClinic-level Capacity for Sustainability as Measured by Provider Survey3.63 score on a scaleStandard Deviation 2.03
Secondary

Impact of PREVENT Tool on Mean Change in Patient's Body Mass Index (BMI)

Collected from patient's medical record. BMI z-score is a standardized calculation accounting age and sex using the Centers for Disease Control and Prevention Growth Charts. A z-score represents the standard deviation from the population mean. A z-score of zero represents the population mean. Mean change in BMI z-score was calculated by subtracting the baseline mean from the follow-up mean for each intervention group. A decrease in z-score is a favorable outcome.

Time frame: At baseline and 3-months

Population: Parents and providers were not evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Patients - Wait-List ControlImpact of PREVENT Tool on Mean Change in Patient's Body Mass Index (BMI)0.09 z-scoreStandard Deviation 0.22
Patients - PREVENT ToolImpact of PREVENT Tool on Mean Change in Patient's Body Mass Index (BMI)-.03 z-scoreStandard Deviation 0.16
Secondary

Impact of PREVENT Tool on Patient's Attitudes Toward Behavior Change

A survey (6-question) administered to patients will assess attitudes toward and readiness for behavior change. Questions are asked using a 5-point Likert scale (range: 0-5) with a higher score indicating more positive attitudes.

Time frame: At baseline and 3-months

Population: Parents and providers were not evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Patients - Wait-List ControlImpact of PREVENT Tool on Patient's Attitudes Toward Behavior Change0.16 score on a scaleStandard Deviation 0.76
Patients - PREVENT ToolImpact of PREVENT Tool on Patient's Attitudes Toward Behavior Change0.23 score on a scaleStandard Deviation 1.08
Secondary

Impact of PREVENT Tool on Patient's Cholesterol

Collected from patient's medical record

Time frame: At baseline and 3-months

Population: Data was not collected and outcome measure was dropped.

Secondary

Impact of PREVENT Tool on Patient's Fasting Blood Glucose

Collected from patient's medical record

Time frame: At baseline and 3-months

Population: Data was not collected and outcome measure was dropped.

Secondary

Impact of PREVENT Tool on Patient's Systolic and Diastolic Blood Pressure

Collected from patient's medical record. Blood pressure is measured in mmHg. The mean change was calculated by subtracting the baseline mean from the follow-up mean for each intervention group.

Time frame: At baseline and 3-months

Population: Parents and providers were not evaluable for this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Patients - Wait-List ControlImpact of PREVENT Tool on Patient's Systolic and Diastolic Blood PressureSystolic blood pressure-1.38 mmHgStandard Deviation 10
Patients - Wait-List ControlImpact of PREVENT Tool on Patient's Systolic and Diastolic Blood PressureDiastolic blood pressure-0.49 mmHgStandard Deviation 6.7
Patients - PREVENT ToolImpact of PREVENT Tool on Patient's Systolic and Diastolic Blood PressureSystolic blood pressure0.65 mmHgStandard Deviation 11.1
Patients - PREVENT ToolImpact of PREVENT Tool on Patient's Systolic and Diastolic Blood PressureDiastolic blood pressure-1.83 mmHgStandard Deviation 10.5
Secondary

Maintenance of PREVENT Tool as Measured by Provider Perceptions of Ease of Use of the Tool

Qualitative in-depth interview with providers who used the PREVENT tool. Qualitative content analysis methods were used to summarize key themes related to provider perceptions of the tool and ability to use the tool in routine clinical practice.

Time frame: 3-months

Population: Parents and patients were not evaluable for this outcome measure.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ProvidersMaintenance of PREVENT Tool as Measured by Provider Perceptions of Ease of Use of the ToolUser friendly, easily navigable platform; color coding and visualizations were easy to understand4 Participants
ProvidersMaintenance of PREVENT Tool as Measured by Provider Perceptions of Ease of Use of the ToolProviders liked having clear, concrete recommendations to give patients4 Participants
Secondary

Maintenance of PREVENT Tool as Measured by Provider Perceptions of Feasibility of the Tool

Qualitative in-depth interview with providers who used the PREVENT tool. Qualitative content analysis methods were used to summarize key themes related to provider perceptions of the tool and ability to use the tool in routine clinical practice.

Time frame: 3-months

Population: Parents and patients were not evaluable for this outcome measure.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ProvidersMaintenance of PREVENT Tool as Measured by Provider Perceptions of Feasibility of the ToolMore feasible to have clinic staff that could prepare the tool and review recommendations4 Participants
ProvidersMaintenance of PREVENT Tool as Measured by Provider Perceptions of Feasibility of the ToolMore feasible to deliver PREVENT during longer appointments; time could be a barrier4 Participants
ProvidersMaintenance of PREVENT Tool as Measured by Provider Perceptions of Feasibility of the ToolLack of electronic health record integration was a key barrier to using PREVENT in routine practice.4 Participants
Secondary

Parent's Perceptions of Usability/Acceptability of PREVENT Tool

Semi-structured interviews with parents/guardians (n=10) of study participants.

Time frame: 3-months

Population: Data was not collected for this outcome measure as the investigators were unable to successfully recruit parents for follow-up interviews over the phone.

Secondary

Patient's Perceptions of Usability/Acceptability of PREVENT Tool

Semi-structured interviews with adolescent study participants (n=10).

Time frame: 3-months

Population: Data was not collected on this outcome measure as the investigators were unable to successfully recruit patients for follow-up interviews over the phone.

Secondary

Provider's Motivation for Sustained Use of PREVENT Tool

A survey (8 questions) assessed provider's intent to change their behavior and continue using PREVENT. Questions were adapted from Legare's CPD Reaction Questionnaire and asked using a 5-point Likert scale (range 1-5). An average of all responses was calculated with a higher score indicating greater motivation for sustained use.

Time frame: 3-months

Population: Parents and patients were not evaluable for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
ProvidersProvider's Motivation for Sustained Use of PREVENT Tool2.79 score on a scaleStandard Deviation 1.2

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