Behavioral Therapy + Support for Caregivers for Childhood Obesity (FRESH-LC Trial)
Palo Alto (17 mi)Overseen byKerri Boutelle, Ph.D.
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of California, San Diego
No Placebo Group
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).
Is the treatment Parent-based treatment- All caregivers (PBT-AC) a promising treatment for childhood obesity?Yes, Parent-based treatment- All caregivers (PBT-AC) is a promising treatment for childhood obesity. Research shows that family-based behavioral treatments, which involve parents in managing their children's weight through healthy eating and exercise, are effective. These treatments help improve children's weight and health by focusing on family involvement and setting goals for both children and parents.34678
Do I have to stop taking my current medications to join the trial?The trial protocol does not specify if you need to stop taking your current medications. However, it requires that the parent and child are on a stable medication regimen for at least 3 months for anything that could impact weight.
What safety data exists for behavioral therapy and support for caregivers in treating childhood obesity?The provided research does not directly address safety data for behavioral therapy and support for caregivers in treating childhood obesity. However, it discusses the effectiveness of various parent-based and family-based treatments, including cognitive behavioral therapy and psychoeducation, in managing childhood obesity. These studies focus on outcomes like BMI z-scores and weight loss patterns, but do not specifically mention safety concerns or adverse effects.25678
What data supports the idea that Behavioral Therapy + Support for Caregivers for Childhood Obesity is an effective treatment?The available research shows that family-based behavioral treatment (FBT) is considered the gold-standard for childhood obesity, involving both children and their parents. Studies indicate that when parents actively participate in the weight loss process, it improves both short- and long-term weight regulation for children. Additionally, increasing physical activity is important for maintaining long-term weight control. While parent-based treatment (PBT) alone, which involves only the parents, could be similarly effective, the direct involvement of children in FBT has shown positive results. These findings suggest that involving the family, especially parents, in the treatment process is beneficial for managing childhood obesity.15678
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
I am the main person who prepares food at home and agree to complete all required assessments.
My child is overweight or obese for their age.
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.
My child or I am taking insulin for Type II Diabetes.
I cannot do physical activities because of a major disability.
My child or I am taking medication for weight loss.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: PBT-ACExperimental Treatment1 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 EducationActive Control1 Intervention
This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress via telehealth.
Find a clinic near you
Research locations nearbySelect from list below to view details:
UC San Diego Center for Healthy Eating and Activity Research (CHEAR)La Jolla, CA
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
University of Southern CaliforniaCollaborator
National Institutes of Health (NIH)Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
Children's Hospital Los AngelesCollaborator
References
Family-based behavioural intervention for obese children. [2022]The family environment can contribute to the development of obesity. Parenting styles may influence the development of food preferences and the ability of a child to regulate intake. Parents and other family members arrange a common, shared environment that may be conducive to overeating or a sedentary lifestyle. Family members serve as models, and reinforce and support the acquisition and maintenance of eating and exercise behaviours. Family-based interventions are needed to modify these variables in treating obese children. We have made significant progress in developing interventions that target obese 8-12 year-old children, completing four 10-year follow-up studies that provide support for two factors that are useful in childhood obesity treatment. First, our research suggests that the direct involvement of at least one parent as an active participant in the weight loss process improves short- and long-term weight regulation. Second, our research suggests that increasing activity is important for maintenance of long-term weight control. Correlational analyses on the 10-year database suggest that family and friend support for behaviour change are related to long-term outcome. Family-based obesity treatment provides interventions for both children and their parents, but children benefit more from treatment than their parents. These positive results provide an encouraging basis for optimism that further development of interventions, based on newer research on family processes and behaviour changes, can be useful in treating childhood obesity.
Randomized controlled comparison of two cognitive behavioral therapies for obese children: mother versus mother-child cognitive behavioral therapy. [2018]Parent-child treatments have been shown to be superior to child-focused treatments of childhood obesity. Yet until now, the comparative effectiveness of parent-only and parent-child approaches has been little studied.
Current approaches to the management of pediatric overweight and obesity. [2021]Family-based behavioral intervention has been demonstrated to be an effective and safe treatment for childhood obesity and should be considered a first-line treatment option. However, access to such intensive evidence-based treatment is limited and, currently, obesity care is dominated by high intensity behavioral treatment implemented in specialty clinics or less effective low intensity treatments implemented in primary care. However, capitalizing on the established and ongoing relationship between primary care providers and families, primary care providers have an invaluable role in early identification of overweight and obesity, and subsequent referral to an evidence-based treatment. Key aspects of effective treatment include: early intervention, moderate intensity to high intensity intervention of sufficient duration, multicomponent intervention targeting dietary modification, physical activity and behavioral strategies, family involvement and goals targeting family members, and follow-up contact during maintenance. The purpose of this review is to present the current empirically supported treatment options for pediatric obesity including primary care-based interventions and diagnostic tools, multicomponent behavioral intervention with a focus on family-based behavioral intervention, immersion treatment, and pharmacologic and surgical management.
Family-Based Behavioral Treatment for Childhood Obesity: Caretaker-Reported Barriers and Facilitators. [2023]Family-based behavioral treatments are effective ways to promote children's weight management through healthy eating and exercise. However, programs typically have high attrition and low attendance. The aim of this study was to obtain in-depth caregiver input on barriers and facilitators to participate in a family-based, behavioral childhood obesity treatment program.
Effect of Attendance of the Child on Body Weight, Energy Intake, and Physical Activity in Childhood Obesity Treatment: A Randomized Clinical Trial. [2022]Family-based weight loss treatment (FBT) is considered the gold-standard treatment for childhood obesity and is provided to the parent and child. However, parent-based treatment (PBT), which is provided to the parent without the child, could be similarly effective and easier to disseminate.
Cost-effectiveness of Family-Based Obesity Treatment. [2018]We translated family-based behavioral treatment (FBT) to treat children with overweight and obesity and their parents in the patient-centered medical home. We reported greater reductions in child and parent weight at 6 and 24 months compared with an attention-controlled information control (IC) group. This article reports the cost-effectiveness of long-term weight change for FBT compared with IC.
Evaluation of dyadic changes of parent-child weight loss patterns during a family-based behavioral treatment for obesity. [2022]Family-based treatment (FBT) for children with overweight and obesity is a package that includes nutrition and physical activity education, as well as parenting and behavior therapy skills. To date, the majority of research suggests that one of the best predictors of child weight loss is parent weight loss. However, the bidirectional processes facilitating parent-child weight loss are not well understood.
Parents as Agents of Change in Managing Pediatric Obesity: A Randomized Controlled Trial Comparing Cognitive Behavioral Therapy versus Psychoeducation Interventions. [2023]Background: Obesity interventions for parents of children with obesity can improve children's weight and health. This randomized controlled trial (RCT) evaluated whether a parent-based intervention based on cognitive behavioral therapy (CBT) principles was superior to a parent-based intervention based on a psychoeducation program (PEP) in improving children's obesity. Methods: This study was a pragmatic, two-armed, parallel, superiority RCT. Conducted at a Canadian outpatient pediatric obesity management clinic (September 2010-January 2014), this trial included families with children 8-12 years with an age- and sex-specific BMI ≥85th percentile. The 16-week manualized interventions were similar in content and delivered to parents exclusively, with different theoretical underpinnings. The primary outcome was children's BMI z-score at postintervention (4 months). Secondary outcomes included anthropometric, lifestyle, psychosocial, and cardiometabolic variables. Data were collected at preintervention (0 months), postintervention (4 months), 10, and 16 months. Intention-to-treat analysis using linear mixed models was used to assess outcomes. Results: Among 52 randomly assigned children, the mean age (standard deviation) was 9.8 (1.7) years and BMI z-score was 2.2 (0.3). Mean differences in BMI z-score were not significantly different between the CBT (n = 27) and PEP (n = 25) groups from 0 to 4-, 10-, and 16-month follow-up. At 4 months, the mean difference in BMI z-score from preintervention between the CBT (-0.05, 95% CI = -0.09 to 0.00) and PEP (-0.04, 95% CI = -0.09 to 0.01) groups was -0.01 (95% CI = -0.08 to 0.06, p = 0.80). Similar results were found across all secondary outcomes. Conclusions: Our CBT-based intervention for parents of children with obesity was not superior in reducing BMI z-score vs. our PEP-based intervention.