- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04618458
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
38
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
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).
|
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
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
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
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.
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.
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)
December 1, 2020
Primary Completion (ACTUAL)
December 18, 2021
Study Completion (ACTUAL)
December 18, 2021
Study Registration Dates
First Submitted
October 19, 2020
First Submitted That Met QC Criteria
October 30, 2020
First Posted (ACTUAL)
November 6, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 8, 2022
Last Update Submitted That Met QC Criteria
August 5, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on Power to Prevent
-
Institut de Formation et de Recherche en Médecine...RecruitingSport Injury | Blister of FootFrance
-
Centre Hospitalier René DubosCompletedBacillus Cereus Infection
-
Butler HospitalNational Institute of Mental Health (NIMH); Brown UniversityRecruitingSuicidal Ideation | Suicide, Attempted | Suicide | Suicide and Self-harmUnited States
-
Butler HospitalAmerican Foundation for Suicide Prevention (AFSP)RecruitingSuicidal Ideation | Suicide, Attempted | Suicide | Suicide and Self-harmUnited States
-
Instituto Nacional de Cancer, BrazilEnrolling by invitationRadiodermatitis | Injury, RadiationBrazil
-
University Hospital, ToulouseNot yet recruiting
-
University of Maryland, BaltimoreNational Institute of Nursing Research (NINR)CompletedOsteoporosis | Health Behaviors
-
Tel Hai CollegeCompletedFeeding and Eating DisordersIsrael
-
Yale UniversityNational Institute on Drug Abuse (NIDA); Case Western Reserve University; DePaul... and other collaboratorsCompleted
-
CentraCareActive, not recruitingConcussion, BrainUnited States