Trial Outcomes & Findings for PREVENT Tool Study: Late Effects Clinic (NCT NCT04530825)
NCT ID: NCT04530825
Last Updated: 2023-04-25
Results Overview
* 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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
At baseline and 3-months
Results posted on
2023-04-25
Participant Flow
Participant milestones
| Measure |
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
|
Parents
-Semi-structured interviews
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
29
|
16
|
13
|
|
Overall Study
COMPLETED
|
4
|
28
|
16
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
Parents
-Semi-structured interviews
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
No longer eligible on the day of baseline visit
|
0
|
1
|
0
|
1
|
|
Overall Study
Did not complete follow-up
|
3
|
0
|
0
|
0
|
Baseline Characteristics
Race was not collected on Parents.
Baseline characteristics by cohort
| Measure |
Providers
n=4 Participants
* 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
|
Parents
n=28 Participants
-Semi-structured interviews
|
Patients - Wait-List Control
n=16 Participants
* 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.
|
Patients - PREVENT Tool
n=12 Participants
* 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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
White
|
3 Participants
n=4 Participants • Race was not collected on Parents.
|
—
|
15 Participants
n=16 Participants • Race was not collected on Parents.
|
9 Participants
n=12 Participants • Race was not collected on Parents.
|
27 Participants
n=32 Participants • Race was not collected on Parents.
|
|
Age, Continuous
|
40.5 years
n=4 Participants • Age was not collected on Parents.
|
—
|
16.0 years
n=16 Participants • Age was not collected on Parents.
|
17.0 years
n=12 Participants • Age was not collected on Parents.
|
19.4 years
n=32 Participants • Age was not collected on Parents.
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants • Sex was not collected on Parents.
|
—
|
6 Participants
n=16 Participants • Sex was not collected on Parents.
|
6 Participants
n=12 Participants • Sex was not collected on Parents.
|
15 Participants
n=32 Participants • Sex was not collected on Parents.
|
|
Sex: Female, Male
Male
|
1 Participants
n=4 Participants • Sex was not collected on Parents.
|
—
|
10 Participants
n=16 Participants • Sex was not collected on Parents.
|
6 Participants
n=12 Participants • Sex was not collected on Parents.
|
17 Participants
n=32 Participants • Sex was not collected on Parents.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants • Ethnicity was not collected on Parents.
|
—
|
0 Participants
n=16 Participants • Ethnicity was not collected on Parents.
|
0 Participants
n=12 Participants • Ethnicity was not collected on Parents.
|
0 Participants
n=32 Participants • Ethnicity was not collected on Parents.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=4 Participants • Ethnicity was not collected on Parents.
|
—
|
16 Participants
n=16 Participants • Ethnicity was not collected on Parents.
|
12 Participants
n=12 Participants • Ethnicity was not collected on Parents.
|
32 Participants
n=32 Participants • Ethnicity was not collected on Parents.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants • Ethnicity was not collected on Parents.
|
0 Participants
Ethnicity was not collected on Parents.
|
0 Participants
n=16 Participants • Ethnicity was not collected on Parents.
|
0 Participants
n=12 Participants • Ethnicity was not collected on Parents.
|
0 Participants
n=32 Participants • Ethnicity was not collected on Parents.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants • Race was not collected on Parents.
|
—
|
0 Participants
n=16 Participants • Race was not collected on Parents.
|
0 Participants
n=12 Participants • Race was not collected on Parents.
|
0 Participants
n=32 Participants • Race was not collected on Parents.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=4 Participants • Race was not collected on Parents.
|
—
|
0 Participants
n=16 Participants • Race was not collected on Parents.
|
0 Participants
n=12 Participants • Race was not collected on Parents.
|
1 Participants
n=32 Participants • Race was not collected on Parents.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants • Race was not collected on Parents.
|
—
|
0 Participants
n=16 Participants • Race was not collected on Parents.
|
0 Participants
n=12 Participants • Race was not collected on Parents.
|
0 Participants
n=32 Participants • Race was not collected on Parents.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants • Race was not collected on Parents.
|
—
|
0 Participants
n=16 Participants • Race was not collected on Parents.
|
1 Participants
n=12 Participants • Race was not collected on Parents.
|
1 Participants
n=32 Participants • Race was not collected on Parents.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants • Race was not collected on Parents.
|
—
|
1 Participants
n=16 Participants • Race was not collected on Parents.
|
2 Participants
n=12 Participants • Race was not collected on Parents.
|
3 Participants
n=32 Participants • Race was not collected on Parents.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants • Race was not collected on Parents.
|
—
|
0 Participants
n=16 Participants • Race was not collected on Parents.
|
0 Participants
n=12 Participants • Race was not collected on Parents.
|
0 Participants
n=32 Participants • Race was not collected on Parents.
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
28 participants
n=28 Participants
|
16 participants
n=16 Participants
|
12 participants
n=12 Participants
|
60 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: At baseline and 3-monthsPopulation: Providers and parents were not evaluable for this outcome measure.
* 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.
Outcome measures
| Measure |
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
|
Parents
-Semi-structured interviews
|
Patients - Wait-List Control
n=16 Participants
* 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.
|
Patients - PREVENT Tool
n=12 Participants
* 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.
|
|---|---|---|---|---|
|
Mean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) Survey
|
—
|
—
|
43.3 minutes/week
Standard Deviation 341.6
|
16.8 minutes/week
Standard Deviation 357.7
|
PRIMARY outcome
Timeframe: At baseline and 3-monthsPopulation: Providers and parents were not evaluable for this outcome measure.
* 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.
Outcome measures
| Measure |
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
|
Parents
-Semi-structured interviews
|
Patients - Wait-List Control
n=16 Participants
* 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.
|
Patients - PREVENT Tool
n=12 Participants
* 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.
|
|---|---|---|---|---|
|
Mean Change in Minutes of Vigorous Physical Activity Per Week (From Self Report) Survey
|
—
|
—
|
-211.4 minutes/week
Standard Deviation 241.6
|
-1.4 minutes/week
Standard Deviation 109.0
|
PRIMARY outcome
Timeframe: At baseline and 3-monthsPopulation: Providers and parents were not evaluable for this outcome measure.
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.
Outcome measures
| Measure |
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
|
Parents
-Semi-structured interviews
|
Patients - Wait-List Control
n=16 Participants
* 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.
|
Patients - PREVENT Tool
n=12 Participants
* 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.
|
|---|---|---|---|---|
|
Mean Change in Number of Food Intake Behaviors Met
|
—
|
—
|
0.15 score on a 0-5 scale
Standard Deviation 1.1
|
0.78 score on a 0-5 scale
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 3-monthsPopulation: Parents and patients were not evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Providers
n=4 Participants
* 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
|
Parents
-Semi-structured interviews
|
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.
|
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.
|
|---|---|---|---|---|
|
Provider's Satisfaction of PREVENT Tool: Survey
|
3.61 score on a scale
Standard Deviation 1.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0-3 monthsPopulation: Data was not collected on this outcome measure as the study team was unable to consistently observe study visits due to COVID-19 restrictions.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3-monthsPopulation: Parents and patients were not evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Providers
n=4 Participants
* 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
|
Parents
-Semi-structured interviews
|
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.
|
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.
|
|---|---|---|---|---|
|
Provider's Motivation for Sustained Use of PREVENT Tool
|
2.79 score on a scale
Standard Deviation 1.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3-monthsPopulation: Parents and patients were not evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Providers
n=4 Participants
* 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
|
Parents
-Semi-structured interviews
|
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.
|
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.
|
|---|---|---|---|---|
|
Maintenance of PREVENT Tool as Measured by Provider Perceptions of Feasibility of the Tool
More feasible to deliver PREVENT during longer appointments; time could be a barrier
|
4 Participants
|
—
|
—
|
—
|
|
Maintenance of PREVENT Tool as Measured by Provider Perceptions of Feasibility of the Tool
More feasible to have clinic staff that could prepare the tool and review recommendations
|
4 Participants
|
—
|
—
|
—
|
|
Maintenance of PREVENT Tool as Measured by Provider Perceptions of Feasibility of the Tool
Lack of electronic health record integration was a key barrier to using PREVENT in routine practice.
|
4 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3-monthsPopulation: Parents and patients were not evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Providers
n=4 Participants
* 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
|
Parents
-Semi-structured interviews
|
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.
|
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.
|
|---|---|---|---|---|
|
Maintenance of PREVENT Tool as Measured by Provider Perceptions of Ease of Use of the Tool
User friendly, easily navigable platform; color coding and visualizations were easy to understand
|
4 Participants
|
—
|
—
|
—
|
|
Maintenance of PREVENT Tool as Measured by Provider Perceptions of Ease of Use of the Tool
Providers liked having clear, concrete recommendations to give patients
|
4 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3-monthsPopulation: Data was not collected on this outcome measure as the investigators were unable to successfully recruit patients for follow-up interviews over the phone.
Semi-structured interviews with adolescent study participants (n=10).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3-monthsPopulation: Data was not collected for this outcome measure as the investigators were unable to successfully recruit parents for follow-up interviews over the phone.
Semi-structured interviews with parents/guardians (n=10) of study participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 3-monthsPopulation: Parents and providers were not evaluable for this outcome measure.
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.
Outcome measures
| Measure |
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
|
Parents
-Semi-structured interviews
|
Patients - Wait-List Control
n=16 Participants
* 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.
|
Patients - PREVENT Tool
n=12 Participants
* 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.
|
|---|---|---|---|---|
|
Impact of PREVENT Tool on Mean Change in Patient's Body Mass Index (BMI)
|
—
|
—
|
0.09 z-score
Standard Deviation 0.22
|
-.03 z-score
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: At baseline and 3-monthsPopulation: Parents and providers were not evaluable for this outcome measure.
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.
Outcome measures
| Measure |
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
|
Parents
-Semi-structured interviews
|
Patients - Wait-List Control
n=16 Participants
* 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.
|
Patients - PREVENT Tool
n=12 Participants
* 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.
|
|---|---|---|---|---|
|
Impact of PREVENT Tool on Patient's Systolic and Diastolic Blood Pressure
Systolic blood pressure
|
—
|
—
|
-1.38 mmHg
Standard Deviation 10.0
|
0.65 mmHg
Standard Deviation 11.1
|
|
Impact of PREVENT Tool on Patient's Systolic and Diastolic Blood Pressure
Diastolic blood pressure
|
—
|
—
|
-0.49 mmHg
Standard Deviation 6.7
|
-1.83 mmHg
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: At baseline and 3-monthsPopulation: Data was not collected and outcome measure was dropped.
Collected from patient's medical record
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 3-monthsPopulation: Data was not collected and outcome measure was dropped.
Collected from patient's medical record
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 3-monthsPopulation: Parents and providers were not evaluable for this outcome measure.
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.
Outcome measures
| Measure |
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
|
Parents
-Semi-structured interviews
|
Patients - Wait-List Control
n=16 Participants
* 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.
|
Patients - PREVENT Tool
n=12 Participants
* 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.
|
|---|---|---|---|---|
|
Impact of PREVENT Tool on Patient's Attitudes Toward Behavior Change
|
—
|
—
|
0.16 score on a scale
Standard Deviation 0.76
|
0.23 score on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: 3-monthsPopulation: Parents and patients were not evaluable for this outcome measure.
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).
Outcome measures
| Measure |
Providers
n=4 Participants
* 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
|
Parents
-Semi-structured interviews
|
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.
|
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.
|
|---|---|---|---|---|
|
Clinic-level Capacity for Sustainability as Measured by Provider Survey
|
3.63 score on a scale
Standard Deviation 2.03
|
—
|
—
|
—
|
Adverse Events
Providers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients - Wait-List Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients - PREVENT Tool
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Maura Kepper, Ph.D.
Washington University School of Medicine
Phone: 314-935-0142
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place