Behavioral Treatments for Childhood Obesity

(FRESH-FR Trial)

Recruiting at 1 trial location

Overseen By Kerri Boutelle, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Weight loss medications

Disqualifiers: Acute psychiatric disorders, Type 1 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 22

Duration: 6 months

280 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{2 6 9 11 12}

Who Is on the Research Team?

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.

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

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?

Group I: Regulation of Cues + Experimental Treatment 1 Intervention

The ROC+ program includes all of the components of ROC as well as nutrition education and reducing energy intake

Group II: Regulation of Cues Experimental Treatment 1 Intervention

The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning targeting increasing satiety responsiveness and decreasing food cue responsiveness.

Group III: Family-Based Treatment Active Control 1 Intervention

The FBT program provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.

Group IV: Health Education Active Control 1 Intervention

The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

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

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

• Childhood obesity
• Overweight in children

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current approaches to the management of pediatric overweight and obesity. Coppock, JH., Ridolfi, DR., Hayes, JF., et al.[2021]

A 5-year study involving 162 families showed that family-based behavioral treatments for childhood obesity are most effective when both child and parent behaviors are targeted and reinforced together.

Key factors for successful outcomes in children include self-monitoring, changes in eating habits, and parental involvement, while parents benefit from monitoring their weight and having lower baseline overweight percentages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year follow-up of family-based behavioral treatments for childhood obesity. Epstein, LH., McCurley, J., Wing, RR., et al.[2019]

Family-based care for childhood obesity should not only focus on the parent-youth relationship but also consider the entire family dynamics, as these can significantly influence weight-related behaviors.

The paper emphasizes the need for family systems theory (FST) in obesity treatment, providing a clinical algorithm for healthcare providers to assess and intervene in family dynamics, which could lead to more effective obesity management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Functioning and Childhood Obesity Treatment: A Family Systems Theory-Informed Approach. Pratt, KJ., Skelton, JA.[2021]

Family-based behavioral treatment (FBT) is being tested for effectiveness in pediatric primary care settings, involving 528 families with children who are overweight or obese, over a 24-month period.

The study aims to show that FBT will lead to better weight management outcomes for children and their parents compared to usual care, potentially making this evidence-based treatment more accessible in everyday healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing family-based behavioral treatment in the pediatric primary care setting: Design of the PLAN study. Epstein, LH., Schechtman, KB., Kilanowski, C., et al.[2022]

Family-based behavioral weight loss treatment (FBT) was effective in promoting weight loss in children across different socioeconomic and racial groups, with a study involving 172 youth over 12 months.

However, Black children and those from low-income families experienced less weight loss by the 4-month mark, indicating a need for further research to optimize FBT for these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Racial and socioeconomic disparities in the efficacy of a family-based treatment programme for paediatric obesity. Davison, GM., Fowler, LA., Ramel, M., et al.[2021]

In a study involving 150 children with overweight or obesity, those participating in family-based behavioral treatment (FBT) or a parent-only variant (PBT) showed significant decreases in eating disorder (ED) concerns and attitudes after treatment, rather than an increase.

The findings suggest that these treatments do not exacerbate ED symptoms, providing reassurance to parents that enrolling their children in these evidence-based programs is safe and beneficial for addressing obesity without increasing the risk of eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in eating disorder symptoms following pediatric obesity treatment. Eichen, DM., Strong, DR., Rhee, KE., et al.[2020]

The study involved 181 parent-child dyads who participated in a 16-session family-based behavioral weight loss treatment (FBT) program, which successfully led families to make healthier modifications in their home food environment.

Reducing the availability of high-energy-dense (RED) foods and electronics in the home during FBT was positively associated with improvements in child weight and related outcomes, highlighting the importance of the home environment in achieving weight loss success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home and neighbourhood built environment features in family-based treatment for childhood obesity. Hayes, JF., Balantekin, KN., Conlon, RPK., et al.[2020]

In a study involving 137 parent-child pairs, parent weight loss was identified as the strongest predictor of child weight loss in a family-based behavioral treatment program for pediatric obesity.

Additionally, creating a home environment with fewer high-fat foods, more low-fat options, and better parental monitoring practices significantly contributed to greater rates of weight loss in children, highlighting the importance of these specific treatment components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based treatment program contributors to child weight loss. Boutelle, KN., Kang Sim, DE., Rhee, KE., et al.[2021]

The LAUNCH-HV intervention, which included home visits, significantly reduced the BMI z-score in preschool children with obesity compared to pediatrician counseling, indicating its effectiveness in weight management.

In contrast, the LAUNCH-clinic intervention did not show a significant difference in BMI z-score reduction compared to pediatrician counseling, suggesting that more intensive behavioral support is necessary for effective treatment.

NCBI (Pubmed)

pubmed.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. Stark, LJ., Clifford, LM., Towner, EK., et al.[2021]

A family-based intervention for managing childhood obesity was effective, showing a greater improvement in weight among schoolchildren with overweight or obesity when both the child and at least one parent were involved in the program.

The study involved 60 schoolchildren aged 6 to 12 years, with significant weight differences observed between the intervention group and the control group, highlighting the importance of family engagement in obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Family intervention for the management of overweight and obesity in schoolchildren]. González-Heredia, R., Castañeda-Sánchez, O., López-Morales, CM., et al.[2019]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of dyadic changes of parent-child weight loss patterns during a family-based behavioral treatment for obesity. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Adapting family-based treatment for paediatric obesity: A randomized controlled pilot trial. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Current approaches to the management of pediatric overweight and obesity. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Five-year follow-up of family-based behavioral treatments for childhood obesity. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Family Functioning and Childhood Obesity Treatment: A Family Systems Theory-Informed Approach. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Implementing family-based behavioral treatment in the pediatric primary care setting: Design of the PLAN study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Racial and socioeconomic disparities in the efficacy of a family-based treatment programme for paediatric obesity. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Change in eating disorder symptoms following pediatric obesity treatment. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Home and neighbourhood built environment features in family-based treatment for childhood obesity. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Family-based treatment program contributors to child weight loss. [2021]

11. United States pubmed.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]

12. Mexico pubmed.ncbi.nlm.nih.gov

[Family intervention for the management of overweight and obesity in schoolchildren]. [2019]