Weight Loss for Childhood Obesity

RM
JA
Overseen ByJessica Alcala, BSN
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how obesity affects children's breathing and exercise capacity over time. Researchers are examining children first studied between 2016 and 2023, focusing on those with and without obesity. Two groups exist: one group with obesity may choose to follow a weight loss program, while the other will not receive any specific intervention. This trial suits children who participated in the original study as 8-12-year-olds and can follow directions for tests like breathing exercises. As an unphased trial, it offers participants the opportunity to contribute to important research that could improve health outcomes for children with obesity.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that losing weight can be safe for children with obesity when done correctly. One study found that more than half of the children who followed a structured weight-loss program had a lower Body Mass Index (BMI) by the end. This finding suggests that weight loss is generally well-tolerated and beneficial for many children. The studies reported no major negative effects from the weight loss process.

Weight loss programs in clinical trials are closely monitored by healthcare professionals to ensure safety and effectiveness. Those considering participation should consult a healthcare provider to understand how the program works and any possible risks.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the long-term respiratory effects of obesity in children and the potential benefits of voluntary weight loss. Unlike standard care, which typically focuses on weight management programs or medication, this study aims to understand how weight changes over time can impact lung health. It pays special attention to the natural progression of respiratory issues in children with obesity, both with and without active weight loss efforts. This could provide new insights into how early obesity impacts health over time and guide future treatment strategies.

What evidence suggests that weight loss might be an effective treatment for obesity?

Research has shown that losing weight can help children with obesity lower their body mass index (BMI) scores. In one study, 56% of children in a weight-loss program lowered their BMI scores, with over a third reducing it by at least 0.25. Another study found that programs involving families or groups effectively treat childhood obesity. Digital health tools also helped lower BMI scores and increased daily physical activity by more than 7 minutes. In this trial, some children with obesity may choose to participate in a voluntary weight loss program, while others will be part of a control group with no intervention. Overall, structured weight loss has shown promising results in managing childhood obesity and improving related health issues.26789

Who Is on the Research Team?

TG

Tony G Babb, Ph.D.

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I was part of the R01 HL136643 study as an 8-12-year-old between 2016-2023.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Initial assessment of body composition, respiratory function, exercise tolerance, and dyspnea on exertion in children with and without obesity

1 week
1 visit (in-person)

Follow-up

Participants are monitored for changes in body composition, respiratory function, exercise tolerance, and dyspnea on exertion after 6 years of aging

6 years
1 visit (in-person) every 9 months

Weight Loss Program (optional)

Participants with obesity may opt into a weight loss program under standard care

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Weight Loss

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Children Without ObesityExperimental Treatment0 Interventions
Group II: Children With Obesity (Control)Experimental Treatment0 Interventions
Group III: Children With ObesityExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Long-term effects of 12-month integrated weight-loss ...

In our study, 56% of children participating in the full intervention reduced their BMI z-score, more than a third by at least 0.25, and 18% ...

Effectiveness of an Intervention Programme for Childhood ...

Objectives. To assess the effectiveness of a programmed family/group intervention to reduce weight in the treatment of obesity in children 7 to 12 years old ...

Clinical Practice Guideline for the Evaluation and ...

The current and long-term health of 14.4 million children and adolescents is affected by obesity,1,2 making it one of the most common pediatric ...

Integrating digital health into pediatric obesity management

Participants in the intervention group showed a significant reduction in BMI z-score and percentage overweight, along with increased MVPA (+7.4 ​min/day) and ...

American Heart Association Childhood Obesity Research ...

There are no prospective long-term studies of lifestyle-intervention–induced weight loss in children and adolescents that demonstrate a beneficial effect on ...

Pediatric obesity—Long‐term consequences and effect ... - PMC

Consequently, childhood obesity increases the risk for premature mortality, and the mortality rate is three times higher already before 30 years of age compared ...

Financial Incentives and Treatment Outcomes in ...

This study found that financial incentives improved outcomes of a dietary intervention among adolescents with severe obesity.

Childhood and Adolescent Obesity - American Society for ...

Five-year follow-up data from studies of adolescents undergoing sleeve gastrectomy demonstrate better weight reduction, improvement in medical conditions, and ...

Long-term effects of 12-month integrated weight-loss ...

In the group of children participating in the full intervention, a reduction in BMI SDS was found in 56% of children, with 35% reducing their ...