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?

This trial aims to determine which type of behavioral treatment best assists children who are overweight and highly responsive to food cues. It compares several programs: Regulation of Cues (ROC), which teaches coping and self-monitoring skills; ROC+, which includes nutrition education; Family-Based Behavioral Treatment (FBT), focusing on behavior and parenting skills; and basic Health Education. Children aged 7–12 who are overweight and particularly sensitive to food cues may be suitable candidates, especially if they have a parent who can participate in the sessions and support healthy eating at home. As an unphased trial, this study provides a unique opportunity for families to explore effective behavioral treatments tailored to their needs.

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

Research has shown that the treatments under study for childhood obesity, such as the Regulation of Cues (ROC) and Family-Based Treatment (FBT), are generally safe for children. Studies on similar programs have found no evidence of serious harm. For instance, research on weight management programs for children has shown they can lower BMI without causing major side effects. Additionally, studies on family-based treatments have reported no safety issues, indicating they are well-tolerated. While more research is needed to confirm these findings, current data suggests these methods are safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for childhood obesity because they involve unique behavioral strategies that go beyond traditional methods, like standard diet and exercise programs. The "Regulation of Cues" treatment focuses on teaching kids and their families how to respond to hunger and food cues, which is a fresh approach to managing cravings and satiety. The "Regulation of Cues +" treatment builds on this by adding nutritional education to help reduce calorie intake effectively. Meanwhile, "Family-Based Treatment" emphasizes not only nutrition and activity but also involves parents actively with behavioral and parenting skills to help maintain a balanced energy intake. These innovative approaches aim to create sustainable, healthy habits, which could lead to more effective long-term weight management for children.

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

Research has shown that the Regulation of Cues (ROC) program, a treatment in this trial, might help children respond less strongly to food-related triggers. This program teaches kids to better recognize true hunger and fullness, promoting healthier eating habits. Some studies suggest that ROC can address childhood obesity by reducing eating when not hungry. Another treatment arm in this trial, the enhanced ROC+ version, includes nutrition lessons and emphasizes eating less, potentially increasing its effectiveness. Both programs appear promising, but further research is needed to confirm their benefits. ^{2 3 6 7 8}

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

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 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]

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]

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]

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]

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]

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]

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 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]

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24459240/

An intervention based on Schachter's externality theory for ... Conclusion: The ROC intervention may be useful with overweight and obese children. Larger, fully powered studies are needed to further evaluate the efficacy of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4314468/

The Intervention for Regulations of Cues Trial (iROC) These studies have the opportunity to introduce a new paradigm for the treatment of childhood obesity, targeting reduction of food cue reactivity and tolerance.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714414001773

The Intervention for Regulations of Cues Trial (iROC) This study will rigorously test extinction processes as a method of decreasing physiological and psychological responses to food cues in overweight and obese ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01442142

A Study to Determine the Effectiveness of a Self-regulation ... The central hypothesis is that CRST and CAAT will reduce eating in the absence of hunger in overweight children immediately following treatment and 6-months ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2792381

Effect of a Novel Intervention Targeting Appetitive Traits on ... This randomized clinical trial compares the effects of regulation of cues weight loss treatment with behavioral weight loss treatment on ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4007101/

An Intervention Based on Schachter's Externality Theory for ... Conclusion The ROC intervention may be useful with overweight and obese children. Larger, fully powered studies are needed to further evaluate ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2820245

Interventions for Weight Management in Children and ... In the short term, weight management interventions led to lower BMI in children and adolescents, with no evidence of serious harm.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424001459

A randomized controlled trial examining general parenting ... This clinical trial tests the effect of parenting training on childhood obesity. Results will inform the development of more effective treatments.