200 Participants NeededMy employer runs this trial

Wise Interventions for Childhood Obesity

TR
Overseen ByThomas Robinson, MD, MPH
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 improve weight management for children with obesity by testing new psychological activities alongside a family-based behavioral program. The researchers seek to determine if these "wise" interventions, which focus on self-affirmation and a growth mindset, help children manage their weight more effectively than traditional education and behavioral treatment alone. Ideal participants are children aged 10-15 with obesity who can participate in the program with a parent or guardian. The study may lead to better health and well-being for children struggling with obesity. As an unphased trial, this study offers families a unique opportunity to contribute to innovative research that could transform obesity treatment for children.

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

Previous studies have tested activities like values self-affirmation and growth mindset exercises to ensure safety and effectiveness. Research has shown that children and teenagers generally tolerate these activities well. For instance, one study found that values affirmation helps kids accept health information better and motivates behavior change, indicating its safety in healthcare.

Additionally, family-based programs for weight control have demonstrated improvements in BMI and, in some cases, reductions in waist size and body fat. These findings suggest that combining these activities with behavioral treatments is likely safe for children with obesity.

Overall, evidence indicates that these activities typically do not cause harmful effects and are considered safe for children.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments because they incorporate "wise interventions" like growth mindset and values self-affirmation, which are new approaches in tackling childhood obesity. Unlike traditional methods that focus mainly on health education and standard behavioral treatments, these interventions aim to change how children perceive challenges and setbacks, potentially making them more resilient and motivated in their weight control efforts. By combining these psychological strategies with usual care, there's hope for a more holistic and effective approach to managing childhood obesity.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

This trial will compare two approaches to managing childhood obesity. One group will receive wise interventions, which include values self-affirmation and growth mindset strategies, combined with a usual care family-based behavioral intervention for weight control. Studies suggest that wise interventions can improve how children with obesity see themselves and may enhance weight management efforts. The other group will receive health education alongside the same family-based behavioral intervention. Research has shown that programs focusing on lifestyle changes can help reduce obesity in children at both 6 and 12 months, and involving the whole family has been successful in managing childhood obesity. These findings suggest that combining wise interventions with lifestyle programs could effectively help children manage their weight.678910

Who Is on the Research Team?

TR

Thomas Robinson, MD, MPH

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for children with obesity who are able to participate in a family-based, group weight control program. Specific inclusion and exclusion criteria are not detailed, but generally targets kids struggling with excess weight.

Inclusion Criteria

Participation in a behavioral weight control program
My child and I both agree to take part in the study.
I am 10-15 years old and have obesity based on my BMI.

Exclusion Criteria

Conditions limiting participation in the assessments
Medical conditions affecting growth
Conditions limiting participation in the interventions
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-month family-based, group behavioral weight control program with or without wise social psychological interventions

6 months
Measurements at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for changes in BMI and other health metrics 6 months after completing the treatment

6 months
Measurement at 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Education plus usual care behavioral treatment
  • Wise interventions (values self-affirmation and growth mindset) plus usual care behavioral treatment

Trial Overview

The study compares two approaches: one group gets usual behavioral treatment plus special psychological activities (self-affirmation and growth mindset), while the other gets behavioral treatment plus extra educational content. Participants are randomly assigned.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Wise interventions plus behavioral RxExperimental Treatment1 Intervention
Group II: Education plus behavioral RxActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

Childhood Obesity Interventions by Setting

This narrative review aims to provide a cross section of the scientific literature regarding obesity interventions by setting, including school- ...

Family-Centered Positive Behavior Support Interventions in ...

The outcome of childhood obesity management depends highly upon patient compliance. European Journal of Pediatrics. 2004; 163(2):99–104. DOI ...

Cronicon

behavioral lifestyle interventions are more effective in reducing obesity in children than standard care or self-help at 6 months and 12 months ...

Evidence-Based Interventions for Childhood Obesity

Overweight and obesity in childhood may result in a wide range of negative physical health problems as well as psychosocial concerns across the life course.

A Family-Based Weight Management Program Improved ...

A Family-Based Weight Management Program Improved Self-Perception Among Obese Children. Including a mental health component as part of a ...

A Randomized Trial of a Diet and Exercise Intervention ... - PMC

Of the 23 interventions included, less than half presented outcome data. In addition, statistically significant effects were rare, and only five studies ...

The Effects of a Values Alignment Intervention on Eating ...

This study examined the effects of an adapted single session grounded in values alignment and designed to improve eating habits in adolescents.

A randomized study of values affirmation to promote interest in ...

A streamlined values affirmation, designed for feasibility in a healthcare setting, can promote interest in diabetes prevention among women at high-risk.

Stanford APBI Trial - Stanford Medicine - Stanford University

Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity ... values self-affirmation and growth mindset ...

The Role of the Self in Physical Health: Testing the Effect of ...

For example, self-affirmation is associated with greater acceptance of health information and stronger motivation for health behavior change ...