Behavioral Therapy + Support for Caregivers for Childhood Obesity

(FRESH-LC Trial)

Overseen By Kerri Boutelle, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Insulin, Weight loss medications

Disqualifiers: Type 1 diabetes, Severe autism, others

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

Compensation: Varies

Number of Visits: 5

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help Latino children who are overweight or have obesity. It compares a telehealth program, where caregivers receive coaching on promoting healthy habits like better eating and exercise, with a standard health education program (Health Education, HE). The goal is to determine which method more effectively supports children's health. Families with children aged 5 to 12 who struggle with weight issues might be a good fit, especially if one caregiver can actively participate in the sessions. Families must be able to join virtual meetings and plan to stay in the San Diego area during the study. As an unphased trial, this study offers families the chance to contribute to innovative research that could shape future health interventions.

Will I have to stop taking my current medications?

The trial requires that participants are on a stable medication regimen for at least 3 months for anything that could impact weight. However, if you or your child are taking insulin for Type II Diabetes or weight loss medications, you cannot participate in the trial.

What prior data suggests that this behavioral program is safe for caregivers and children?

Research has shown that family-based programs to help children with overweight or obesity are generally safe. These programs involve parents in changing habits related to diet and exercise.

In past studies, children in these programs improved their weight without major side effects. Parental involvement positively affects children's habits, such as exercise and screen time, without causing harm.

These programs support the whole family, not just the child, and focus on lifestyle changes rather than medication, which are usually well-tolerated.

While specific safety data for this exact program might not be available, similar programs in the past have shown no significant negative effects, suggesting a low risk of harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parent-based Treatment for All Caregivers (PBT-AC) because it takes a unique approach to addressing childhood obesity by empowering caregivers as the primary agents of change. Unlike traditional treatments that might directly target the child through diet or exercise programs, PBT-AC focuses on educating and supporting caregivers via telehealth, allowing them to implement lifestyle changes within the family. This method leverages the influence of caregivers to create a healthier home environment, which could lead to more sustainable and impactful outcomes. Additionally, the telehealth delivery makes it accessible to families who may have difficulty attending in-person sessions, breaking down barriers to effective treatment.

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

Research shows that family-based behavioral treatment (FBT) effectively manages childhood obesity. In this trial, one group of participants will receive Parent-based treatment-All caregivers (PBT-AC), which delivers elements of FBT exclusively to caregivers as agents of change via telehealth. Studies have found that children receiving this treatment achieve better weight outcomes than those receiving standard care. This approach involves training parents and implementing lifestyle changes, which can help lower a child's body mass index (BMI) z scores—a measure comparing a child's weight to peers. FBT is a proven method for addressing overweight and obesity in children, emphasizing caregivers' crucial role in fostering healthier habits. Another group in this trial will receive Health Education, providing information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress via telehealth. ^{1 2 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?

The FRESH-LC trial is for Latino families in the San Diego area with children aged 5-12 who are overweight or obese. It requires a primary caregiver and another adult willing to attend sessions, both able to read Spanish or English at a 5th grade level. Participants must have stable medication regimens and access to Zoom-capable devices.

Inclusion Criteria

Family must plan to remain in the San Diego or surrounding areas within the time frame of the study

I have a caregiver over 18 who can attend at least half of my treatment sessions.

I can read and understand Spanish or English at least at a 5th grade level and am willing to participate in groups.

Exclusion Criteria

My child has a chronic illness like cystic fibrosis or type 1 diabetes that requires a doctor's supervision for diet or exercise.

Parent is pregnant or planning on becoming pregnant during the duration of the study

My parent had bariatric surgery less than 6 months ago or is planning to have one.

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 group program (PBT-AC or HE) delivered via telehealth

6 months

5 visits (virtual) at baseline, mid-treatment, post-treatment, 6-month, and 12-month follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Health Education (HE)
• Parent-based treatment- All caregivers (PBT-AC)

Trial Overview This study tests a telehealth family-based behavioral program aimed at managing childhood obesity among Latinos (PBT-AC), against standard health education (HE). The focus is on providing support for caregivers and promoting healthy behaviors within the family unit.

How Is the Trial Designed?

Group I: PBT-AC Experimental Treatment 1 Intervention

PBT-AC includes the elements of family based behavioral treatment for obesity, delivered exclusively to caregivers as the agents of change, via telehealth.

Group II: Health Education Active Control 1 Intervention

This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress via telehealth.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

A study involving 56 obese children and their families found that both parent-only and parent-child cognitive behavioral therapy (CBT) treatments equally reduced children's percent overweight after 6 months.

Both treatment approaches also similarly improved behavioral and psychological issues in children and mothers, indicating that either method can be effective for addressing childhood obesity and its associated challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled comparison of two cognitive behavioral therapies for obese children: mother versus mother-child cognitive behavioral therapy. Munsch, S., Roth, B., Michael, T., et al.[2018]

Involving at least one parent actively in the weight loss process significantly improves both short- and long-term weight regulation in obese children aged 8-12 years, based on findings from four 10-year follow-up studies.

Increasing physical activity is crucial for maintaining long-term weight control, and support from family and friends is linked to better outcomes in childhood obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based behavioural intervention for obese children. Epstein, LH.[2022]

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 study involving 21 parents/guardians identified key barriers to participating in family-based obesity treatment programs, including lack of time, frustration from past failures, and perceived costs of healthy options.

Facilitators for participation included convenient locations, supportive program leaders, and rewards for children's progress, highlighting the importance of caregiver input in designing effective obesity interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-Based Behavioral Treatment for Childhood Obesity: Caretaker-Reported Barriers and Facilitators. Staiano, AE., Marker, AM., Comeaux, J., et al.[2023]

A study involving 150 overweight and obese children and their parents found that parent-based treatment (PBT) is as effective as family-based treatment (FBT) for child weight loss over 24 months, with no significant difference in outcomes.

Both treatments resulted in similar improvements in child and parent weight loss, dietary intake, and physical activity, suggesting that PBT could be a more accessible option for addressing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Attendance of the Child on Body Weight, Energy Intake, and Physical Activity in Childhood Obesity Treatment: A Randomized Clinical Trial. Boutelle, KN., Rhee, KE., Liang, J., et al.[2022]

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]

Family-based behavioral treatment (FBT) for children with overweight or obesity resulted in significant weight loss for both children and parents over 24 months, with children losing an average of 2.0 U in percent over BMI (%OBMI) compared to a 4.4 U increase in the control group.

FBT was found to be more cost-effective than the information control group, with incremental cost-effectiveness ratios of $116.1 per U of %OBMI for children and $83.5 for parents, indicating that FBT provides better health outcomes for the investment made.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of Family-Based Obesity Treatment. Quattrin, T., Cao, Y., Paluch, RA., et al.[2018]

A randomized controlled trial involving 52 families with children aged 8-12 years found that a parent-based intervention using cognitive behavioral therapy (CBT) principles did not significantly outperform a psychoeducation program (PEP) in reducing children's BMI z-scores over 16 months.

Both interventions showed similar outcomes in children's BMI z-scores and other health-related measures, indicating that the type of theoretical approach may not be as crucial as previously thought in obesity interventions for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents as Agents of Change in Managing Pediatric Obesity: A Randomized Controlled Trial Comparing Cognitive Behavioral Therapy versus Psychoeducation Interventions. Spence, ND., Newton, AS., Keaschuk, RA., et al.[2023]

Citations

1. health-excellence-action.org health-excellence-action.org/project/caregivers-childhood-obesity-chronic-disease-risk

SCCLH #2 At present, the most effective program for weight management in children is family-based treatment (FBT), which is delivered to the target child and a parent ( ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12053569/

Parenting Training Plus Behavioral Treatment for Children ... These studies found that PT combined with a lifestyle intervention led to a decrease in BMI z scores (mean change, −0.20 units) after treatment ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2805906

Family-Based Behavioral Treatment for Childhood Obesity ... At 24 months, children receiving family-based treatment had better weight outcomes than those receiving usual care based on the difference in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01722032

Study Details | NCT01722032 | USDA Healthy Caregivers/ ... Findings from this investigation should inform both the fields of childhood obesity prevention and early childhood research about the effects of an obesity ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/15374416.2023.2251164

Evidence Base Update on Behavioral Treatments for ... Family-based treatment (FBT) remains a well-established treatment for overweight and obesity in children and is now well-established in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11201836/

The Impact of Parental Involvement in the Prevention and ... Conclusion: Parental involvement in childhood obesity interventions significantly impacts BMI z-score, exercise levels, screen time, and dietary ...

7. 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.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833516

Parenting Training Plus Behavioral Treatment for Children ... The findings suggest that FBT reduces weight status in children with overweight or obesity but that additional intensive PT does not further improve outcomes.