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

167 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this proposed study is to collect initial efficacy data on a telehealth family-based behavioral program for Latino children with overweight or obesity, which also includes additional caregiver support (PBT-AC), compared with health education (HE).

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 data supports the effectiveness of the treatment Behavioral Therapy + Support for Caregivers for Childhood Obesity?

Research shows that family-based treatments, which involve parents in the weight loss process, can improve children's weight management. Studies suggest that when parents actively participate, it can lead to better short- and long-term weight control for children. ^{1 2 3 4 5}

Is behavioral therapy and support for caregivers safe for treating childhood obesity?

The research does not specifically mention any safety concerns related to behavioral therapy and support for caregivers in treating childhood obesity, suggesting it is generally considered safe. ^{1 2 4 5 6}

How is the Parent-based treatment- All caregivers (PBT-AC) for childhood obesity different from other treatments?

The Parent-based treatment- All caregivers (PBT-AC) is unique because it focuses on involving all caregivers in the child's life, using behavioral therapy principles to manage childhood obesity. This approach emphasizes the role of parents as agents of change, which is different from traditional treatments that may not engage the entire family or focus on caregiver involvement. ^{1 2 5 7 8}

Research Team

Kerri Boutelle, Ph.D.

Principal Investigator

UC San Diego

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

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. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

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

4. United States 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. [2022]

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

Cost-effectiveness of Family-Based Obesity Treatment. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Randomized controlled comparison of two cognitive behavioral therapies for obese children: mother versus mother-child cognitive behavioral therapy. [2018]

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

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

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

Family-Based Behavioral Treatment for Childhood Obesity: Caretaker-Reported Barriers and Facilitators. [2023]