Obesity, Childhood

31

Review clinical trials related to Obesity, Childhood. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Breastmilk in Response to a Bout of Exercise

The purpose of this study is to unveil the mechanistic benefits of a bout of postpartum maternal exercise on infant health that are provided by breastmilk.

Participants needed: 60
Trial details
Age: 18-45Biological sex: FemaleType: ObservationalSponsor: Mayo ClinicUpdated: Jun 24, 2026Locations: 1Duration: 1 Month
Eligibility criteria

Active coronary artery disease or heart failure. [+12]

Status: Not yet recruiting

GLP-1 Plus Lifestyle for Overall Wellness: Find Your Way Forward

The rapid emergence of new and highly effective obesity medications has turned the field of pediatric weight management on its head. Adolescents living with obesity, their caregivers, healthcare providers, healthcare systems, policymakers, and payors are now wondering what role health behavior and lifestyle treatment (HBLT) has in terms of body mass index (BMI) reduction, improvements in quality of life and cardiometabolic health, and mitigating nutritional concerns when medications are used. Is intensive HBLT needed or could low intensity HBLT be an equally effective alternative; and if so, for whom? Our proposed project will answer these important questions that arise daily in the clinical setting and will generate critical new insights to guide decision-making for teens with obesity and the stakeholders who care deeply about them.

Participants needed: 1,020
Trial details
Phase: Phase 4Age: 12-18Biological sex: AllType: InterventionalSponsor: University of MinnesotaUpdated: Jun 16, 2026Locations: 1
Eligibility criteria

Aged 12 to < 18 years at screening [+3]

Diabetes (type 1 or 2) due to safety concerns about proper surveillance of glyce... [+20]

Status: Recruiting

Resilience to the Effects of Advertising in Children

Strong empirical evidence shows food marketing promotes excess energy intake and obesity. Yet, not all children are susceptible to its effects and this variability is poorly understood. Identifying sources of this variability is a public health priority not only because it may elucidate characteristics of children who are most susceptible, but also because it may highlight novel sources of resiliency to overconsumption. The proposed research will use state-of-the art, data-driven approaches to identify neural, cognitive and behavioral phenotypes associated with resiliency to food-cue (i.e. food advertisement) induced overeating and determine whether these phenotypes protect children from weight gain during the critical pre-adolescent period.

Participants needed: 200
Trial details
Age: 7-9Biological sex: AllType: ObservationalSponsor: Penn State UniversityUpdated: May 20, 2026Locations: 1
Eligibility criteria

In order to be enrolled, children must be of good health based on parental self-... [+8]

They are not within the age requirements (< than 7 years old or > than 9 years-o... [+13]

Status: Recruiting

Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function

The investigators will measure blood levels of 1,5-anhydroglucitol in obese children with or without type 2 diabetes and correlate them with parameters related to functional beta-cell mass and glucose metabolism. The values will be compared to those obtained in healthy volunteers. The aim of the study is to test the validity of 1,5-anhydroglucitol as a novel biomarker of beta-cell mass and function in children with obesity with or without type 2 diabetes.

Participants needed: 50
Trial details
Age: 12-16Biological sex: AllType: ObservationalSponsor: Philippe Klee, MD-PhDUpdated: May 18, 2026Locations: 1
Eligibility criteria

Children aged 12 to 16 years [+2]

Patients with diabetes mellitus and positive autoantibodies against islets, insu... [+3]

Status: Recruiting

Genetic Disorders of Obesity Program Database

This study collects data on children with severe, early-onset obesity.

Participants needed: 500
Trial details
Biological sex: AllType: ObservationalSponsor: Baylor College of MedicineUpdated: May 12, 2026Locations: 1Duration: 1 Year
Eligibility criteria

For individuals 2 years and older, BMI > 97 percentile [+1]

No other exclusion criteria

Status: Recruiting

Effects of Blowing Balloon Therapy FUNCTION, DYSPNEA AND QUALITY OF LIFE IN OBESE CHILDREN

The respiratory system is divided into upper and lower tracts and functions through gaseous exchange, ventilation, and perfusion, with normal breathing depending on lung compliance, airway resistance, and muscular strength. Pulmonary function is assessed using spirometry, particularly Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV₁), which are often reduced in obese children due to excess adipose tissue restricting chest wall expansion and diaphragmatic movement, contributing to dyspnea. This randomized controlled trial will be conducted over 10 months in Lahore at selected hospitals and schools, involving 38 obese children (BMI ≥30), aged 6-12 years with mild to moderate dyspnea (RPE 8-14), who will be randomly assigned to either an experimental group receiving blowing balloon therapy or a control group performing splint running (n=19 each). Participants will be screened using the Borg RPE Scale, and data will be analyzed using SPSS version 20.

Participants needed: 38
Trial details
Age: 6-12Biological sex: FemaleType: InterventionalSponsor: Riphah International UniversityUpdated: May 8, 2026Locations: 1
Eligibility criteria

Obese children having 30 or greater than 30 BMI [+2]

Recent asthma exacerbation or respiratory infection in the past 4 weeks. [+3]

Status: Recruiting

A Primary Care Based Intervention to Prevent Childhood Obesity Among Low-income Latino Children

The goal of this study is to evaluate the impact of a primary care based intervention to promote optimal feeding, screen time and sleep practices among low-income Latino infants and toddlers. Infants and caregivers will receive brief health education and coaching sessions from health educators at primary care visits in the first two years of life as well as two text messages per week with health information and tips. Half of the participants will receive the Futuros Fuertes 2.0 intervention that includes health coaching and education on infant feeding, screen time and sleep (intervention group). The other half will receive health coaching and education on safety, home management of childhood illnesses, and promotion of language development (control group). We will look at the impact of the Futuros Fuertes 2.0 intervention on child BMI and various health behaviors.

Participants needed: 576
Trial details
Age: 7-2Biological sex: AllType: InterventionalSponsor: University of California, San FranciscoUpdated: Apr 16, 2026Locations: 2
Eligibility criteria

Parent/caregiver self identifies as Latino [+5]

Status: Recruiting

National Blood Pressure Screening in Children to Improve Paediatric Healthcare in South Africa

The Childhood Hypertension Consortium of South Africa (CHCSA) was established to foster relationships between the healthcare sector and schools through community engagement and outreach as well as contributing to the decolonization of normative paediatric blood pressure reference values. To date, there has been no nation-wide project in South Africa to determine nationally representative normal blood pressure reference values, nor to estimate the true prevalence of hypertension in the paediatric population of the country. This study will provide critical information on the understanding of blood pressure and hypertension in children, especially of African ancestry. Not only will this effort contribute to the development of the first nationally representative normal reference values of blood pressure but will also benefit healthcare providers in the sector with a clear guideline on the management of high blood pressure in children as developed by experts working with these challenges daily.

Participants needed: 22,464
Trial details
Age: 5-18Biological sex: AllType: ObservationalSponsor: North-West University, South AfricaUpdated: Apr 7, 2026Locations: 11
Eligibility criteria

All children between ages 5-<18 years [+1]

circumstances interfere with the participant's ability to give informed consent... [+4]

Status: Recruiting

Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity

This study will address the following aims: Aim 1: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on body adiposity in adolescents with obesity. Aim 1a (Primary): Evaluate intervention effectiveness on total fat mass following the 8-week intervention. Hypothesis 1a: Adolescents randomized to the whole foods intervention will have lower total fat mass (kg) at the 8-week follow-up than those in the control group. Aim 1b: Evaluate intervention effectiveness on anthropometric changes following the 8-week intervention. Hypothesis 1b: Adolescents randomized to the whole foods intervention will have lower weight, BMI-z scores and/or waist circumference at the 8-week follow-up than those in the control group. Secondary Aims: Aim 2: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on diet quality in adolescent and parent pairs during the study period. Hypothesis 2: Adolescents and parents randomized to the whole foods intervention will have higher diet quality scores at the 8-week follow-up than those in the control group. Aim 3: Conduct post-intervention family focus groups to identify how individual/family needs and preferences and social determinants of health (SDOH) may be perceived barriers and/or facilitators of diet adherence to a whole foods diet pattern.

Participants needed: 60
Trial details
Age: 10+Biological sex: AllType: InterventionalSponsor: Vanderbilt UniversityUpdated: Mar 23, 2026Locations: 1
Eligibility criteria

10-18 years of age at time of initial screening; [+12]

Outside of the specified age range; [+18]

Status: Recruiting

Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction

This is a three-month randomized controlled trial to investigate the effects of auricular acupressure versus Intermittent carbohydrate restriction on cardiometabolic risk in obese children with gastric heat and dampness obstruction.

Participants needed: 240
Trial details
Age: 6-18Biological sex: AllType: InterventionalSponsor: Children's Hospital of Fudan UniversityUpdated: Mar 19, 2026Locations: 1
Eligibility criteria

Have at least one of the following cardiometabolic risk factors: overweight or o... [+1]

Diagnosis of obesity associated with genetic or endocrine diseases, including hy... [+2]

Status: Recruiting

Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care

The goal of this study is to compare two different approaches to help families with children 6-11 years enhance nighttime sleep: 1) working one-on-one with a nurse to learn effective behavioral strategies to try to improve children's sleep or 2) receiving education on a good night's sleep and its benefits. Participating families will meet with a nurse 6 times or receive 6 educational handouts. Participating families will also complete three assessments (start of the study, 2 months and 6 months) during which study questionnaires will be completed, participating children will wear devices that assess sleep and physical activity, participating families will report on what the child ate on two separate days and will be measured for height and weight.

Participants needed: 50
Trial details
Age: 6-11Biological sex: AllType: InterventionalSponsor: Temple UniversityUpdated: Feb 12, 2026Locations: 1
Eligibility criteria

Patient at Temple Pediatrics [+6]

Diagnosed sleep disorder [+2]

Status: Recruiting

Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D)

Investigators propose to study youth across the spectrum of body mass index (BMI) and dysglycemia. This approach will allow investigators to disentangle the relationship of key features of type 2 diabetes (T2D) risk (e.g. obesity) with intermediary physiologic changes (e.g. insulin resistance, inflammation, β-cell dysfunction and dysglycemia) that pose a risk for the brain. Investigators will determine which of these factors are most associated with differences in brain structure and function among groups, over time, and how these effects differ from normal neurodevelopment.

Participants needed: 117
Trial details
Age: 12-17Biological sex: AllType: ObservationalSponsor: Washington University School of MedicineUpdated: Dec 18, 2025Locations: 2
Eligibility criteria

12-17 yrs. old at visit 1, 12-19 yrs. old at visit 2, Tanner II or above (determ...

Syndromic obesity, history of bariatric surgery, insulin treatment (metformin al...

Status: Recruiting

Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline

The goal of this study is to evaluate the effectiveness of CHAMPION ("Comparative-effectiveness of a Healthy lifestyle and Asthma Management Program, In-person vs ONline"), a primary care-based intervention to address childhood obesity and asthma, and test the effectiveness of a telehealth-only version of the program. Intensive Health Behavior and Lifestyle Treatment (IHBLT), when delivered via telehealth vs. in-person among children with overweight or obesity and persistent asthma.

Participants needed: 500
Trial details
Age: 4-17Biological sex: AllType: InterventionalSponsor: Massachusetts General HospitalUpdated: Nov 18, 2025Locations: 1
Eligibility criteria

Age 4-17.9 years at time of screening [+2]

Diagnosis of anorexia nervosa, per child's EHR or caregiver report [+4]

Status: Recruiting

Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance

This is a 12-month, single center, three-arm parallel design, double-blind, randomized clinical trial, to compare the effects of supplemental dietary fiber and metformin (MET) alone and in combination over 12 months on glucose metabolism (insulin resistance \[IR\]), inflammation and BMI in adolescents with obesity and IR, and to assess the relationship between therapeutic intervention(s) and changes in gut microbiome composition and function. Since MET and FIBER have been shown to reduce weight and increase insulin sensitivity through distinct but overlapping mechanisms of action, our central hypothesis is that the combination of FIBER + MET will have a synergistic effect and be more effective than FIBER or MET alone in improving metabolic function (IR) and reducing BMI and inflammation in adolescents with obesity, IR and family history (FM) of T2DM. .

Participants needed: 90
Trial details
Phase: Phase 3Age: 12-18Biological sex: AllType: InterventionalSponsor: University of AlbertaUpdated: Nov 17, 2025Locations: 1
Eligibility criteria

Age 12-18 years [+4]

Current use of insulin or diagnosis of T2DM; [+6]

Status: Recruiting

Food Genetics Behavior Study

A genetic risk for obesity does not always translate to the development of obesity among children, which points to the presence of risk-modifying factors that likely relate to energy balance behaviors as key behavioral drivers. Using an integrated approach to comprehensively examine the interplay between genotype and phenotype, this study will systematically assess the extent to which energy balance behaviors, alone or in combination, in conjunction with family-level influences can modify behavioral and genetic predispositions to childhood obesity in a high-risk sample of predominantly minority children from low-resource backgrounds. Identifying protective factors that may mitigate the impact of obesity risk on weight and adiposity outcomes is critical for moving the prevention of childhood obesity into a new direction.

Participants needed: 242
Trial details
Age: 5-7Biological sex: AllType: InterventionalSponsor: University of PennsylvaniaUpdated: Oct 30, 2025Locations: 1
Eligibility criteria

Healthy children [+4]

Children with serious medical conditions or medication use known to affect food... [+3]

Status: Recruiting

Food-Body-Mind Intervention (16 Weeks)

This novel, timely, and theory-driven Food-Body-Mind intervention addresses the national emergency of mental health crises in early childhood. By targeting Head Start racially/ethnically diverse preschoolers from low-income backgrounds in both urban and rural areas, this intervention is expected to contribute toward reducing health disparities and promoting health equity, a major priority of the NIH and Healthy People 2030. If effective, it can be scalable to Head Start programs across urban and rural settings nationally with long-term sustainability benefits.

Participants needed: 800
Trial details
Phase: Phase 2, Phase 3Age: 3-5Biological sex: AllType: InterventionalSponsor: Michigan State UniversityUpdated: Sep 26, 2025Locations: 1
Eligibility criteria

Parental consent and child (if the child is 5 years) verbal assent received [+3]

preschoolers who have a motor disability or impairment (e.g., cerebral palsy, sp... [+2]

Status: Recruiting

Blood Collection Biorepository for Liver Disease Research

The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.

Participants needed: 1,000
Trial details
Age: 7+Biological sex: AllType: ObservationalSponsor: State University of New York at BuffaloUpdated: Aug 27, 2025Locations: 1Duration: 1 Day
Eligibility criteria

This protocol is to establish a biobank of blood samples from individuals with o... [+1]

Vulnerable populations such as adults unable to consent, infants, pregnant women...

Status: Recruiting

Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents

Childhood obesity is one of the most serious public health challenges of the 21st century, with an increasing prevalence over time in developed countries. Overweight and obese children and adolescents are likely to remain so into adulthood and to develop chronic diseases at a young age, such as diabetes and cardiovascular disease. Obese patients, whether adults or children, are likely to have low serum vitamin D levels due to sequestration and/or volumetric dilution of this fat-soluble vitamin in adipose tissue. Studies have established a link between vitamin D deficiency or insufficiency and chronic diseases such as hypertension, type 2 diabetes and other metabolic problems. Determining physiological 25(OH)D levels to ensure optimal phosphocalcic metabolism and bone mineralisation requires the use of functional markers: parathyroid hormone (PTH) levels, assessment of the intestinal calcium absorption fraction, assessment of bone mineral density and bone mineral content using absorptiometry. Vitamin D deficiency leads to malabsorption of calcium and phosphate in the digestive tract, with concentrations, especially of calcium, tending to fall in plasma, resulting in hypersecretion of PTH, which mobilises bone calcium to maintain subnormal blood calcium levels. Each unit increase in BMI is associated with lower serum vitamin D concentrations: given these low concentrations in this population associated with the risk of developing pathologies, it is important to ensure adequate vitamin D supplementation. The latest paediatric recommendations recommend, for children aged between 1 and 18 with vitamin D deficiency, a supplement of 2,000 IU/day for at least 6 weeks or a bolus of 50,000 IU once a week for at least 6 weeks. There are different dosage regimens for the replacement of vitamin D deficiency depending on the country: there is a lack of data on the appropriate dosage and administration regimens for vitamin D supplementation in cases of deficiency, particularly in obese children and adolescents. A prospective, randomised clinical trial will make it possible to define the vitamin D supplementation regimen best suited to increasing serum vitamin D levels in these children and adolescents suffering from obesity.

Participants needed: 68
Trial details
Phase: Phase 3Age: 5-18Biological sex: AllType: InterventionalSponsor: Hospices Civils de LyonUpdated: Jun 13, 2025Locations: 4
Eligibility criteria

Aged between 5 to 18 year-old [+3]

Symptomatic vitamin D deficiency (tetany, muscular hypotonia, hypocalcaemic seiz... [+11]

Status: Recruiting

Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.

Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.

Participants needed: 600
Trial details
Phase: Phase 1, Phase 2Age: 0-50Biological sex: AllType: InterventionalSponsor: National Institute of Allergy and Infectious Diseases (NIAID)Updated: Jun 8, 2025Locations: 1
Eligibility criteria

Scheduled for cesarean delivery at ≥ 37 weeks [+11]

Delivery at a hospital other than Inova Health System [+14]

Status: Recruiting

Family, Responsibility, Education, Support, and Health for Food Responsiveness

The objective of this proposed study is to compare Regulation of Cues (ROC), Family-Based Treatment (FBT), ROC+ nutrition education and reducing energy intake (ROC+) and a health education comparator (HE) for children with overweight or obesity who are high on food responsiveness (FR).

Participants needed: 280
Trial details
Age: 7-12Biological sex: AllType: InterventionalSponsor: University of California, San DiegoUpdated: May 11, 2025Locations: 2
Eligibility criteria

Informed assent and parental consent [+6]

Acute child psychiatric disorder diagnoses (e.g., acute suicidality, recent hosp... [+4]

Status: Recruiting

Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents

Using a two-group randomized study design, this study aims to evaluate the effectiveness of the adapted family-centered mHealth tool on child BMI z-score (primary outcome), child dietary behaviors, and parental feeding practices, from baseline to 12-month follow-up, among 200 child-parent dyads. It is hypothesized that children in the experimental group will demonstrate larger BMI-z score improvements between baseline and 12-month follow-up compared to children in the comparison group.

Participants needed: 200
Trial details
Age: 8-12Biological sex: AllType: InterventionalSponsor: Tufts UniversityUpdated: Apr 10, 2025Locations: 2
Eligibility criteria

self-identifies as Black/African-American and/or Latino [+15]

has allergies, food aversions, food disorders, or medications with side-effects... [+2]

Status: Recruiting

Efficacy and Safety of Vitamin D Supplementation in Pediatric Patients with Obesity

Introduction: Vitamin D deficiency is commonly observed in patients with obesity, primarily due to sequestration by adipose tissue. Recent research highlights the importance of this deficiency, showing a correlation between low vitamin D levels and mechanisms contributing to insulin resistance. Objectives: This study aims to compare the effects of supplementing with 4,000 IU of vitamin D versus 1,000 IU over six months on insulin resistance and the leptin/adiponectin ratio in school-aged children and adolescents with obesity. Materials and Methods: A controlled clinical trial will be conducted involving 40 children with obesity aged 10 to 18 years (BMI \>95th percentile). Participating children and their parents will undergo measurements such as weight, height, BMI, body fat, and Tanner stage. All participants will receive dietary and physical activity recommendations based on WHO guidelines. After initial assessments, participants will be randomly assigned to receive either 4,000 IU or 1,000 IU of vitamin D. They will be monitored monthly for capsule intake and adverse effects, with follow-up measurements of anthropometry, leptin, adiponectin, insulin \& lipid profile. Statistical Analysis: Baseline characteristics will be compared using t-Student or U-Mann Whitney tests, depending on variable distribution. The intervention's impact will be assessed by calculating deltas for body fat and biochemical measurements, with significance tested using paired t-tests or Wilcoxon tests. Covariance analysis (ANCOVA) will be used to adjust for confounding variables.

Participants needed: 40
Trial details
Age: 10-18Biological sex: AllType: InterventionalSponsor: Coordinación de Investigación en Salud, MexicoUpdated: Mar 24, 2025Locations: 1
Eligibility criteria

Male and female participants. [+4]

Patients with comorbidities not attributable to obesity, such as chronic kidney... [+4]

Status: Recruiting

Increasing Food Literacy in Preschoolers to Reduce Obesity Risk

The goal of this clinical trial is to examine the effects of a nutrition education program on preschool children's food literacy and food acceptance, and to examine the added influence of a healthy eating curriculum and parent education on children's food knowledge and healthful food choices. The project will be evaluated with 450 children ages 3 to 5 years in center-based childcare programs serving predominantly Supplemental Nutrition Assistance Program (SNAP)-eligible families in Pennsylvania. Outcomes for children who receive the added healthy eating curriculum will be compared to children in classrooms that only receive the nutrition education program.

Participants needed: 770
Trial details
Age: 3-6Biological sex: AllType: InterventionalSponsor: Penn State UniversityUpdated: Mar 17, 2025Locations: 1
Eligibility criteria

Preschool children enrolled in participating centers

Severe food allergies that prevent children from consuming project foods [+4]

Status: Recruiting

A Novel Obesity Prevention Program for High-Risk Infants in Primary Care

The goal of this clinical trial is to test a responsive parenting obesity prevention program with infants and caregivers of color (e.g., non-White; Hispanic/Latinx) and/or who are economically marginalized (i.e., publicly insured), delivered via Integrated Behavioral Health (IBH) in pediatric primary care. The main questions it aims to answer are: * 1\) Is the obesity prevention intervention delivered via IBH in pediatric primary care feasible and acceptable to families of color and/or families who are economically marginalized? * 2\) Will it prevent rapid weight gain during infancy? Participants will complete baseline (newborn), post-treatment (9 months), and follow-up assessments (12 months). Participants assigned to treatment will receive 4 prevention sessions as part of their typical well-child visit in pediatric primary care. Researchers hypothesize that infants in the obesity prevention intervention will have stable weight gain compared to infants in the control group (treatment as usual) will experience more rapid weight gain.

Participants needed: 144
Trial details
Phase: Phase 2Age: 1+Biological sex: AllType: InterventionalSponsor: Children's Hospital Medical Center, CincinnatiUpdated: Mar 5, 2025Locations: 1
Eligibility criteria

born 2500 grams or greater [+4]

care in the Neonatal Intensive Care Unit (>7 days) [+4]

Status: Not yet recruiting

A Structured School-based Health Intervention for the Obesity Prevention

The proposed research aims to assess how well a structured intervention is intended to reduce childhood obesity. The intervention addresses food and physical activity behaviors, important determinants of obesity, by concentrating on these elements. The goal of nutritional and physical education is to raise knowledge about the negative effects of obesity and encourage healthy eating habits in children and their caregivers. These educational campaigns will be delivered primarily through schools, guaranteeing a wide audience and consistent messaging.

Participants needed: 1,200
Trial details
Age: 5-12Biological sex: AllType: InterventionalSponsor: Universiti Putra MalaysiaUpdated: Aug 9, 2024Locations: 1
Eligibility criteria

Children of age between 5 to 12 years. [+1]

Children and their parents who did not give assent and consent to participate in...