Telehealth Diabetes Prevention Intervention for African American Youth (TELE-GEN)

August 5, 2022 updated by: Abigail Gamble, University of Mississippi Medical Center

A Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) Pilot Study

The Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) pilot study will evaluate the implementation and early efficacy of a telehealth diabetes prevention intervention for African American (AA) children (8- to 11-years) and their parents. Power to Prevent is a lifestyle diabetes prevention intervention from the Centers for Disease Control and Prevention that is based on the Diabetes Prevention Program and tailored for AA families. To investigators knowledge, this intervention has not been evaluated in a clinical trial with AA families with children at risk for type 2 diabetes mellitus (T2DM), nor been delivered via telehealth. Employing an effectiveness-implementation hybrid study design, investigators aim to concurrently (1) conduct a single arm pilot trial to assess the early efficacy of Power to Prevent delivered via telehealth to treat overweight/obesity in AA children and their parent, while (2) evaluating an implementation strategy for the uptake of the intervention by the pediatric weight management clinic at the University of Mississippi Medical Center. The primary outcome will be stabilization or reduction in BMI z-score in children (index participant) and reduction in parent BMI (co-participant). Parents (n=20) will receive the same telehealth diabetes prevention intervention, which will be delivered by a racially concordant, trained Lifestyle Coach using small-group videoconferencing (5 parents per group). Sessions will consist of nutrition and physical activity behavior change strategies (20 min), problem solving and decision-making skills to circumvent barriers to behavioral change (20 min), and family goal setting and action planning (20 min). Child and parent measures will be assessed at baseline, 12-weeks (post-intervention), and 30-weeks (follow-up). The implementation strategy has two targets: (1) the pediatric weight management clinical and clinical care team; and (2) overweight/obese pediatric patients and their overweight/obese parents. The multifaceted implementation plan includes four discrete strategies: (1) creating a new clinical team; (2) changing the service site; (3) intervening with families; and (4) assessing organizational readiness. Preliminary findings will provide data to design a full-scale study that will include a powered pilot randomized controlled trial to test the interventions effectiveness for preventing T2DM, while evaluating a refined implementation protocol.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) pilot study will evaluate the implementation and early efficacy of a telehealth diabetes prevention intervention for African American (AA) children (8- to 11-years-old) and their parents. Power to Prevent is a lifestyle diabetes prevention intervention from the Centers for Disease Control and Prevention that is based on the Diabetes Prevention Program (DPP) and tailored specifically for AA families. To the knowledge of the study's investigators, this intervention has not yet been evaluated in a clinical trial with AA families with children at risk for T2DM, nor been delivered via telehealth. Employing an effectiveness-implementation hybrid research design, investigators aim to concurrently: (1) conduct a single arm pilot clinical trial to assess the early efficacy of Power to Prevent delivered via telehealth to treat overweight/obesity in AA children and their parent, while (2) comprehensively evaluate a multifaceted implementation strategy for the uptake of Power to Prevent delivered via telehealth by UMMC's pediatric weight management clinic. The primary outcome measure will be stabilization or reduction in BMI z-score in children (index participant) and a reduction in parent BMI (co-participant). Eligible overweight/obese children and their overweight/obese parent (N=20 families) will receive the same telehealth diabetes prevention intervention based on Power to Prevent, which will be delivered by a racially concordant Lifestyle Coach trained in the DPP. Families will meet weekly for 11-weeks (60-min sessions), and then monthly (60-min sessions) for 4 pilot behavioral reinforcement maintenance sessions (15 sessions total). Participants will meet in their respective groups (n=5 families per group) via videoconferencing using Wi-Fi-enabled tablets with cellular connectivity for the entire intervention. Sessions will consist of nutrition and physical activity behavior change strategies (20 min), problem solving and decision-making skills to circumvent barriers to behavioral change (20 min), and family goal setting and action planning (20 min). Assessment measures will be collected from the child and parent participants at baseline, 12-weeks (post-intervention), and 30-weeks (follow-up). The implementation strategy has two targets: (1) UMMC's pediatric weight management clinical setting and clinical care team; and (2) overweight/obese pediatric patients and their overweight/obese parents referred to and engaged in intensive obesity treatment for the prevention of T2DM. The multifaceted implementation plan includes four discrete strategies: (1) creating a new clinical team; (2) changing the service site; (3) intervening with families; and (4) assessing organizational readiness. Preliminary findings will provide sufficient data to design a full-scale effectiveness-implementation hybrid study that will include a powered pilot randomized controlled trial (RCT) to test the interventions effectiveness for preventing T2DM, while evaluating a refined implementation protocol. The overall purpose of the TELE-GEN pilot study directly contributes to the goal of the Jackson Heart Study Community Engagement Center by leveraging existing infrastructure and technology to engage AA families in a virtual community to prevent T2DM. The proposed aims and methods also parallel the NHLBI's strategic goal to advance transnational research.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • AA parents (biological, grandparent, legal guardian) and their 8- to 11-year-old child residing in the same home.
  • One overweight/obese parent (BMI ≥25 kg/m2) and child (≥ 85th% age-/sex-specific BMI).
  • Parent at-risk for diabetes (American Diabetes Association risk test) AND HbA1c 5.7% - 6.4%.

Exclusion Criteria:

  • child or parent has a history of T2DM or a screening HbA1c >6.4%;
  • is taking glucose-lowering medications;
  • is participating in a supervised weight loss program;
  • is pregnant or breast feeding;
  • has conditions limiting participation;
  • has undergone weight loss surgery;
  • is moving out-of-state within 6 months.
  • If a parent becomes pregnant during the study, we will include only child data (index participant) in analyses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention Arm
Eligible overweight/obese children and their overweight/obese parent (N=20 families) will receive the same telehealth diabetes prevention intervention based on Power to Prevent and delivered by a trained lifestyle coach. Families will meet weekly for 11-weeks (60-min sessions), and then monthly (60-min sessions) for 4 pilot behavioral reinforcement maintenance sessions (15 sessions total). Participants will meet in their respective groups (n=5 families per group) via videoconference using Wi-Fi-enabled tablets with cellular connectivity for the entire intervention. Sessions will consist of nutrition and physical activity behavior change strategies (20 min), problem solving and decision-making skills to circumvent barriers to behavioral change (20 min), and family goal setting and action planning (20 min). Assessment measures will be collected from the child and parent participants at baseline, 12-weeks (post-intervention), and 30-weeks (follow-up).
Behavioral: Power to Prevent
Lifestyle diabetes prevention intervention based on the National Diabetes Prevention Program and tailored for African American families. The intervention will be delivered using telehealth and small group videoconferencing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child BMI z-score
Time Frame: Change from baseline child BMI z-score to 12-weeks
Standard anthropometric procedures and a calibrated body weight scale (Seca 777 digital scale with stadiometer) will be used to measure participants' weight (0.1kg), stature (0.1 cm); child BMI percentile will be calculated using the statistic equations made available on the Centers for Disease Control and Prevention (CDC) website
Change from baseline child BMI z-score to 12-weeks
Child BMI z-score
Time Frame: Change from baseline child BMI z-score to 30-weeks
Standard anthropometric procedures and a calibrated body weight scale (Seca 777 digital scale with stadiometer) will be used to measure participants' weight (0.1kg), stature (0.1 cm); child BMI percentile will be calculated using the statistic equations made available on the CDC website
Change from baseline child BMI z-score to 30-weeks
Parent BMI
Time Frame: Change from baseline parent BMI to 12-weeks
Standard anthropometric procedures and a calibrated body weight scale will be used to measure participants' weight (0.1kg), stature (0.1 cm); after converting cm to m, BMI = kg/m2
Change from baseline parent BMI to 12-weeks
Parent BMI
Time Frame: Change from baseline parent BMI to 30-weeks
Standard anthropometric procedures and a calibrated body weight scale will be used to measure participants' weight (0.1kg), stature (0.1 cm); after converting cm to m, BMI = kg/m2
Change from baseline parent BMI to 30-weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child physical activity
Time Frame: Change from baseline child physical activity to 12-weeks
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Change from baseline child physical activity to 12-weeks
Child physical activity
Time Frame: Change from baseline child physical activity to 30-weeks
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Change from baseline child physical activity to 30-weeks
Parent physical activity
Time Frame: Change from baseline parent physical activity to 12-weeks
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Change from baseline parent physical activity to 12-weeks
Parent physical activity
Time Frame: Change from baseline parent physical activity to 30-weeks
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Change from baseline parent physical activity to 30-weeks
Child out-of-school sedentary time
Time Frame: Change from baseline in child out-of-school sedentary time to 12-weeks
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Change from baseline in child out-of-school sedentary time to 12-weeks
Child out-of-school sedentary time
Time Frame: Change from baseline in child out-of-school sedentary time to 30-weeks
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Change from baseline in child out-of-school sedentary time to 30-weeks
Parent sedentary time
Time Frame: Change from baseline in parent sedentary time to 12-weeks
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Change from baseline in parent sedentary time to 12-weeks
Parent sedentary time
Time Frame: Change from baseline in parent sedentary time to 30-weeks
Objective assessment using ActiGraph GT9X Link Accelerometers; child and parent will wear accelerometer continuously for seven day period
Change from baseline in parent sedentary time to 30-weeks
Child Hemoglobin A1c
Time Frame: Change from baseline child Hemoglobin A1c to 12-weeks
A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood
Change from baseline child Hemoglobin A1c to 12-weeks
Child Hemoglobin A1c
Time Frame: Change from baseline child Hemoglobin A1c to 30-weeks
A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood
Change from baseline child Hemoglobin A1c to 30-weeks
Parent Hemoglobin A1c
Time Frame: Change from baseline parent Hemoglobin A1c to 12-weeks
A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood
Change from baseline parent Hemoglobin A1c to 12-weeks
Parent Hemoglobin A1c
Time Frame: Change from baseline parent Hemoglobin A1c to 30-weeks
A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood
Change from baseline parent Hemoglobin A1c to 30-weeks
Child systolic blood pressure
Time Frame: Change from baseline child systolic blood pressure to 12-weeks
Welch Allyn blood pressure unit following the American Heart Association guidelines for children.
Change from baseline child systolic blood pressure to 12-weeks
Child diastolic blood pressure
Time Frame: Change from baseline child diastolic blood pressure to 12-weeks
Welch Allyn blood pressure unit following the American Heart Association guidelines for children.
Change from baseline child diastolic blood pressure to 12-weeks
Child systolic blood pressure
Time Frame: Change from baseline child systolic blood pressure to 30-weeks
Welch Allyn blood pressure unit following the American Heart Association guidelines for children.
Change from baseline child systolic blood pressure to 30-weeks
Child diastolic blood pressure
Time Frame: Change from baseline child diastolic blood pressure to 30-weeks
Welch Allyn blood pressure unit following the American Heart Association guidelines for children.
Change from baseline child diastolic blood pressure to 30-weeks
Parent systolic blood pressure
Time Frame: Change from baseline parent systolic blood pressure to 12-weeks
Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
Change from baseline parent systolic blood pressure to 12-weeks
Parent diastolic blood pressure
Time Frame: Change from baseline parent diastolic blood pressure to 12-weeks
Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
Change from baseline parent diastolic blood pressure to 12-weeks
Parent systolic blood pressure
Time Frame: Change from baseline in parent systolic blood pressure to 30-weeks
Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
Change from baseline in parent systolic blood pressure to 30-weeks
Parent diastolic blood pressure
Time Frame: Change from baseline in parent diastolic blood pressure to 30-weeks
Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.
Change from baseline in parent diastolic blood pressure to 30-weeks
Child resting heart rate
Time Frame: Change from baseline in child resting heart rate to 12-weeks
Welch Allyn blood pressure unit
Change from baseline in child resting heart rate to 12-weeks
Child resting heart rate
Time Frame: Change from baseline in child resting heart rate to 30-weeks
Welch Allyn blood pressure unit
Change from baseline in child resting heart rate to 30-weeks
Parent resting heart rate
Time Frame: Change from baseline in parent resting heart rate to 12-weeks
Welch Allyn blood pressure unit
Change from baseline in parent resting heart rate to 12-weeks
Parent resting heart rate
Time Frame: Change from baseline in parent resting heart rate to 30-weeks
Welch Allyn blood pressure unit
Change from baseline in parent resting heart rate to 30-weeks
Parent readiness to change
Time Frame: Change from baseline in parent readiness to change to 12-weeks
Adapted from Rhee et al., a 6-item instrument to assess parents readiness and intentions to make dietary, physical activity and sedentary changes.
Change from baseline in parent readiness to change to 12-weeks
Parent readiness to change
Time Frame: Change from baseline in parent readiness to change to 30-weeks
Adapted from Rhee et al., a 6-item instrument to assess parents readiness and intentions to make dietary, physical activity and sedentary changes.
Change from baseline in parent readiness to change to 30-weeks
Parent self-efficacy
Time Frame: Change from baseline in parent self-efficacy to 12-weeks
Valid and reliable (Norma et al., 2018) 14-item instrument to measure parent efficacy for influencing children's physical activity, sedentary behavior and dietary behavior using an 11-point Likert scale; 0-not confident, 10-absolutely confident.
Change from baseline in parent self-efficacy to 12-weeks
Parent self-efficacy
Time Frame: Change from baseline in parent self-efficacy to 30-weeks
Valid and reliable (Norma et al., 2018) 14-item instrument to measure parent efficacy for influencing children's physical activity, sedentary behavior and dietary behavior using an 11-point Likert scale; 0-not confident, 10-absolutely confident.
Change from baseline in parent self-efficacy to 30-weeks
Child self-efficacy
Time Frame: Change from baseline in child self-efficacy to 12-weeks
A 9-item valid and reliable instrument by Lassetter et al., 2014 asking children to report their confidence on a 3-point Likert scale for eating healthy and being physically active; 1 item added to assess efficacy for watching less than 2 hours of television (TV) every day.
Change from baseline in child self-efficacy to 12-weeks
Child self-efficacy
Time Frame: Change from baseline in child self-efficacy to 30-weeks
A 9-item valid and reliable instrument by Lassetter et al., 2014 asking children to report their confidence on a 3-point Likert scale for eating healthy and being physically active; 1 item added to assess efficacy for watching less than 2 hours of TV every day.
Change from baseline in child self-efficacy to 30-weeks
Parent perceived family functioning
Time Frame: Change from baseline in parent perceived family functioning to 12-weeks
McMaster Family Assessment Device; a valid and reliable 60-item instrument using a 4-point Likert scale; subscales include problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, general functioning
Change from baseline in parent perceived family functioning to 12-weeks
Parent perceived family functioning
Time Frame: Change from baseline in parent perceived family functioning to 30-weeks
McMaster Family Assessment Device; a valid and reliable 60-item instrument using a 4-point Likert scale; subscales include problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, general functioning
Change from baseline in parent perceived family functioning to 30-weeks
Home physical activity and food environment
Time Frame: Change from baseline in parent perceived home physical activity and food environment to 12-weeks
The Home Environment Survey; valid and reliable instrument (Gattshall et al., 2008) to measure the physical and social environment for food and physical activity; modified to include the physical and social environment for TV time (sedentary behavior); modified to include 79-items total; Dimensions: physical activity availability and accessibility of physical activity equipment, technology and food (i.e. fruit and vegetables); parental role modeling of physical activity, sedentary behavior, and dietary behavior.
Change from baseline in parent perceived home physical activity and food environment to 12-weeks
Home physical activity and food environment
Time Frame: Change from baseline in parent perceived home physical activity and food environment to 30-weeks
The Home Environment Survey; valid and reliable instrument (Gattshall et al., 2008) to measure the physical and social environment for food and physical activity; modified to include the physical and social environment for TV time (sedentary behavior); modified to include 79-items total; Dimensions: physical activity availability and accessibility of physical activity equipment, technology and food (i.e. fruit and vegetables); parental role modeling of physical activity, sedentary behavior, and dietary behavior.
Change from baseline in parent perceived home physical activity and food environment to 30-weeks
Parent perceived child obesity-related behavior
Time Frame: Change from baseline in parent perceived child health behavior to 12-weeks
Child Obesity Behavior Scale; adapted from Rhee et al., 2014; 20-items to measure food, physical activity and sedentary behavior quantity and frequency.
Change from baseline in parent perceived child health behavior to 12-weeks
Parent perceived child obesity-related behavior
Time Frame: Change from baseline in parent perceived child health behavior to 30-weeks
Child Obesity Behavior Scale; adapted from Rhee et al., 2014; 20-items to measure food, physical activity and sedentary behavior quantity and frequency.
Change from baseline in parent perceived child health behavior to 30-weeks
Child perceived obesity-related behavior
Time Frame: Change from baseline in child health behavior to 12-weeks
Healthy Eating and Physical Activity Recall Questionnaire; 9-items (Lassettter et al., 2017); modified to include questions for sedentary environment; 5-items.
Change from baseline in child health behavior to 12-weeks
Child perceived obesity-related behavior
Time Frame: Change from baseline in child health behavior to 30-weeks
Healthy Eating and Physical Activity Recall Questionnaire; 9-items (Lassettter et al., 2017); modified to include questions for sedentary environment; 5-items.
Change from baseline in child health behavior to 30-weeks
Neighborhood Perception Survey
Time Frame: Change from baseline in parent neighborhood perception to 12-weeks
Valid and reliable 31-item instrument used by Mujahod et al., 2007 to assess 7 dimensions of neighborhood: aesthetic quality, walking environment, availability of healthy foods, safety, violence, social cohesion, activities with neighbors.
Change from baseline in parent neighborhood perception to 12-weeks
Neighborhood Perception Survey
Time Frame: Change from baseline in parent neighborhood perception to 30-weeks
Valid and reliable 31-item instrument used by Mujahod et al., 2007 to assess 7 dimensions of neighborhood: aesthetic quality, walking environment, availability of healthy foods, safety, violence, social cohesion, activities with neighbors.
Change from baseline in parent neighborhood perception to 30-weeks
Child waist circumference
Time Frame: Change from baseline in child waist circumference to 12-weeks
A Seca 203 circumference measuring tape will be used to assess participants waist circumference.
Change from baseline in child waist circumference to 12-weeks
Child waist circumference
Time Frame: Change from baseline in child and parent waist circumference to 30-weeks
A Seca 203 circumference measuring tape will be used to assess participants waist circumference.
Change from baseline in child and parent waist circumference to 30-weeks
Parent waist circumference
Time Frame: Change from baseline in parent waist circumference to 12-weeks
A Seca 203 circumference measuring tape will be used to assess participants waist circumference.
Change from baseline in parent waist circumference to 12-weeks
Parent waist circumference
Time Frame: Change from baseline in parent waist circumference to 30-weeks
A Seca 203 circumference measuring tape will be used to assess participants waist circumference.
Change from baseline in parent waist circumference to 30-weeks
Parent stress
Time Frame: Change from baseline in parent stress to 12-weeks
Perceived Stress Scale; 10-items (Cohen, 1994)
Change from baseline in parent stress to 12-weeks
Parent stress
Time Frame: Change from baseline in parent stress to 30-weeks
Perceived Stress Scale; 10-items (Cohen, 1994)
Change from baseline in parent stress to 30-weeks
Child stress
Time Frame: Change from baseline in parent stress to 12-weeks
PROMIS Pediatric Psychological and Physical Stress Scale; 19-items and 26-items (Bevans et al., 2018)
Change from baseline in parent stress to 12-weeks
Child stress
Time Frame: Change from baseline in parent stress to 30-weeks
PROMIS Pediatric Psychological and Physical Stress Scale; 19-items and 26-items (Bevans et al., 2018)
Change from baseline in parent stress to 30-weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child tanner stage
Time Frame: Change from baseline in child tanner stage to 12-weeks
A valid and reliable self-administered rating scale for pubertal development; 5-items. (Carskadon and Acebo, 1993)
Change from baseline in child tanner stage to 12-weeks
Child tanner stage
Time Frame: Change from baseline in child tanner stage to 30-weeks
A valid and reliable self-administered rating scale for pubertal development; 5-items. (Carskadon and Acebo, 1993)
Change from baseline in child tanner stage to 30-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Mississippi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AWD-000933
  • HHSN2682018000151 (OTHER_GRANT: Jackson Heart Study Community Engagement Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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