280 Participants Needed

Behavioral Treatments for Childhood Obesity

(FRESH-FR Trial)

Recruiting at 1 trial location
KM
KB
Overseen ByKerri Boutelle, Ph.D.
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Diego
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?

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).

Will I have to stop taking my current medications?

The trial requires that children and parents be on a stable medication regimen for medications that can impact weight for at least 3 months, so you likely won't need to stop taking your current medications if they meet this condition.

Is family-based behavioral treatment (FBT) for childhood obesity safe for humans?

The research on family-based behavioral treatment (FBT) for childhood obesity does not report any safety concerns, suggesting it is generally safe for humans.12345

How is the Family Based Behavioral Treatment for childhood obesity different from other treatments?

Family Based Behavioral Treatment (FBT) for childhood obesity is unique because it involves both children and their parents in the treatment process, focusing on nutrition, physical activity, and behavior therapy. The treatment's success is often linked to parent weight loss, highlighting the importance of family involvement in achieving better weight loss outcomes for children.678910

What data supports the effectiveness of the treatment Family Based Behavioral Treatment for childhood obesity?

Research shows that family-based behavioral treatment (FBT) is effective for childhood obesity, with successful outcomes linked to both child and parent weight loss. Key factors include targeting both child and parent behaviors, self-monitoring, and family involvement in dietary and physical activity changes.2691112

Who Is on the Research Team?

KB

Kerri Boutelle, Ph.D.

Principal Investigator

UC San Diego

Are You a Good Fit for This Trial?

This trial is for children aged 7-12 with obesity who are very responsive to food. They must be in stable health, able to do physical activities, and not on any new medications for the past 3 months. A parent involved in meal prep must join too, speaking English at least at a 5th-grade level.

Inclusion Criteria

Informed assent and parental consent
My child often feels very hungry and wants to eat a lot.
My child and I can engage in physical activities without health restrictions.
See 4 more

Exclusion Criteria

Acute child psychiatric disorder diagnoses (e.g., acute suicidality, recent hospitalization, psychosis, bulimia nervosa)
First degree relative or someone in the household with anorexia or bulimia nervosa
Parent pregnant, planning on becoming pregnant, or lactating during the study
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly individual sessions for the first 16 sessions, then twice per month for the final 2 months, totaling 20 sessions

6 months
16 weekly visits, 4 bi-monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Assessments at 6-month and 12-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

  • Family Based Behavioral Treatment
  • Health Education
  • Regulation of Cues
  • Regulation of Cues +
Trial Overview The study compares four approaches: Regulation of Cues (ROC), Family-Based Treatment (FBT), ROC+ nutrition education/energy intake reduction (ROC+), and Health Education (HE) to help kids with high food responsiveness manage their weight.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Regulation of Cues +Experimental Treatment1 Intervention
Group II: Regulation of CuesExperimental Treatment1 Intervention
Group III: Family-Based TreatmentActive Control1 Intervention
Group IV: Health EducationActive Control1 Intervention

Family Based Behavioral Treatment is already approved in United States for the following indications:

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Approved in United States as Family-Based Behavioral Treatment for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

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

Collaborator

Trials
2,513
Recruited
4,366,000+

University of Minnesota

Collaborator

Trials
1,459
Recruited
1,623,000+

Published Research Related to This Trial

In a 6-month family-based treatment program for childhood obesity, both parents and children experienced significant weight loss, indicating that family involvement is crucial for effective weight management.
The study found that a parent's initial weight loss positively influenced their child's subsequent weight loss, and vice versa, highlighting the mutual influence between parent and child in achieving weight loss goals.
Evaluation of dyadic changes of parent-child weight loss patterns during a family-based behavioral treatment for obesity.Kang Sim, DE., Strong, DR., Manzano, MA., et al.[2022]
The pilot study involving 77 adolescents showed that family-based treatment for pediatric obesity (FBT-PO) effectively stabilized weight in participants, while those receiving nutrition education counseling (NEC) experienced weight gain.
Although FBT-PO did not significantly reduce body mass index z-scores, it demonstrated potential in preventing further weight gain, highlighting the importance of parental involvement in treating pediatric obesity.
Adapting family-based treatment for paediatric obesity: A randomized controlled pilot trial.Loeb, KL., Le Grange, D., Celio Doyle, A., et al.[2020]
Family-based behavioral interventions are effective and safe for treating childhood obesity and should be prioritized as a first-line treatment option.
Primary care providers play a crucial role in identifying childhood obesity early and referring families to evidence-based treatments, emphasizing the importance of comprehensive, family-involved strategies for successful long-term management.
Current approaches to the management of pediatric overweight and obesity.Coppock, JH., Ridolfi, DR., Hayes, JF., et al.[2021]

Citations

Evaluation of dyadic changes of parent-child weight loss patterns during a family-based behavioral treatment for obesity. [2022]
Adapting family-based treatment for paediatric obesity: A randomized controlled pilot trial. [2020]
Current approaches to the management of pediatric overweight and obesity. [2021]
Five-year follow-up of family-based behavioral treatments for childhood obesity. [2019]
Family Functioning and Childhood Obesity Treatment: A Family Systems Theory-Informed Approach. [2021]
Implementing family-based behavioral treatment in the pediatric primary care setting: Design of the PLAN study. [2022]
Racial and socioeconomic disparities in the efficacy of a family-based treatment programme for paediatric obesity. [2021]
Change in eating disorder symptoms following pediatric obesity treatment. [2020]
Home and neighbourhood built environment features in family-based treatment for childhood obesity. [2020]
Family-based treatment program contributors to child weight loss. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
A pilot randomized controlled trial of a behavioral family-based intervention with and without home visits to decrease obesity in preschoolers. [2021]
[Family intervention for the management of overweight and obesity in schoolchildren]. [2019]
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