Family-Based Intervention for Childhood Obesity

Recruiting at 1 trial location

Overseen By Alma D Guerrero, MD, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Weight loss medications

Disqualifiers: Prader-Willi syndrome, weight loss program

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

182 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Latino families address childhood obesity by teaching caregivers healthier lifestyle habits for their children. It focuses on reducing sugary drink consumption, limiting screen time, and increasing physical activity through in-person sessions and interactive text messages. Families will compare this approach, called the Family-Based Childhood Obesity Intervention, to standard care, which includes nutrition advice and food vouchers. The trial targets Latino caregivers of 2- to 5-year-old children who are overweight and can participate in both Spanish and English.

As an unphased trial, this study offers families the chance to participate in innovative research that could influence future health guidelines.

Do I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you or the child are taking weight loss medication, you would be excluded from participating.

What prior data suggests that this family-based childhood obesity intervention is safe?

Research has shown that family-based programs for childhood obesity are generally safe and effective. These programs help children manage their weight by promoting healthy eating and exercise habits. Evidence suggests that children in these programs often achieve better weight outcomes than those receiving standard care.

The program typically includes activities such as training for parents or caregivers, with both in-person sessions and interactive text messaging. These activities aim to encourage healthy changes within the family, which is especially important for young children.

Overall, studies report that these programs are well-received, with no major safety concerns. Families involved in similar programs have not experienced significant negative effects, making it a safe option for those interested in participating. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family-Based Childhood Obesity Intervention because it takes a holistic approach, involving both children and their caregivers in the treatment process. Unlike traditional options that focus solely on nutrition and exercise for children, this intervention includes a comprehensive parenting and caregiver training program. It features weekly in-person sessions combined with interactive text messaging, which aims to reinforce healthy habits through ongoing support and engagement. This innovative blend of in-person and digital communication might improve adherence and long-term success in managing childhood obesity.

What evidence suggests that this family-based childhood obesity intervention is effective for reducing childhood obesity?

This trial will compare a Family-Based Childhood Obesity Intervention with usual care. Research has shown that involving families can effectively address childhood obesity. Studies indicate that these programs help children lose weight by promoting healthy eating and regular exercise. One study found that family-based programs led to weight loss in children. Another study identified these programs as one of the best ways to manage childhood obesity. By including family members, these programs create a supportive environment for children to adopt healthier habits. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for Latino families with a child aged 2-5 who's overweight, defined by BMI>85% for their age and sex. Caregivers must spend at least 20 hours per week with the child, be willing to participate in the study activities, and complete data collection protocols. They should speak Spanish or English. Those caring for children on weight loss meds or programs, or with conditions like Prader-Willi Syndrome are excluded.

Inclusion Criteria

I am a caregiver willing and able to join the study as determined by an assessment.

I care for a child aged 2-5 who is overweight.

I care for a young child for at least 20 hours a week.

Exclusion Criteria

I care for a child with a condition causing overweight, like Prader-Willi Syndrome.

I am a caregiver of a child in a weight loss program.

I am a caregiver of a child on weight loss medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a family-based childhood obesity intervention with 4-week in-person sessions and mobile phone components, followed by 2 months of mobile phone booster messages.

3 months

4 weekly in-person sessions, followed by mobile phone interactions

Follow-up

Participants are monitored for changes in BMI and other health outcomes at multiple time points post-intervention.

12 months

Data collection at baseline, 1, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Family-Based Childhood Obesity Intervention

Trial Overview

The trial tests a family-based obesity intervention tailored for Latino families that combines in-person strategies with mobile technology and considers cultural factors like familism. It aims to promote healthy behaviors and reduce childhood obesity/cardiovascular risk disparities among Latinos.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

The study's intervention is a parenting/caregiver training program that includes 1-month of weekly in-person sessions plus multi-media interactive text messaging. The weekly 1-hour-in-person sessions will be coupled with four interactive messages per week for a period of 4 weeks total, followed by "booster" text messages after completing the 4-week program.

Group II: Usual Care Active Control 1 Intervention

"Usual care" for caregivers of 2- to-5-year-olds will include the Women Infant and Children services : (1) monthly vouchers for nutritious food; (2) individual nutrition counseling at least twice per year; (3) nutrition education two times per year (1:1 counseling or online health education modules); and (4) referrals to family services.

Family-Based Childhood Obesity Intervention is already approved in United States, Canada, European Union for the following indications:

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

• Childhood Obesity Prevention
• Weight Management in Children and Adolescents

Approved in Canada as Family-Based Obesity Prevention Intervention for:

• Childhood Obesity Prevention
• Healthy Lifestyle Promotion in Families

Approved in European Union as Family-Based Childhood Obesity Intervention for:

• Childhood Obesity Prevention
• Family-Based Weight Management

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

University of California, Merced

Collaborator

Trials

18

Recruited

6,100+

Published Research Related to This Trial

The review analyzed 31 family-based interventions for pediatric obesity, categorizing them into four types based on their focus on parent behaviors and assessment of child outcomes.

The authors suggest that current interventions could benefit from a broader focus on family dynamics and parenting skills, as this may enhance the effectiveness of obesity treatment in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based interventions for pediatric obesity: methodological and conceptual challenges from family psychology. Kitzmann, KM., Beech, BM.[2006]

Family-based behavioral interventions are effective in improving weight-related outcomes in children, with 93% of systematic reviews indicating success in managing child weight and behaviors.

Parent-targeted strategies, whether involving parents alone or with their children, showed similar or greater effectiveness, emphasizing the importance of parental involvement in promoting healthy eating and exercise habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of family-based weight management interventions for children with overweight and obesity: an umbrella review. Chai, LK., Collins, C., May, C., 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 study evaluates a 10-week family-based lifestyle intervention for children aged 8-12 with overweight and obesity, aiming to enroll 186 families in British Columbia, Canada, to assess its impact on child body mass index (BMI) and related health behaviors.

The intervention includes 26 hours of contact through group sessions and online resources, focusing on healthy eating, physical activity, and mental health, with outcomes measured at baseline, post-intervention, and follow-up to determine effectiveness and implementation success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based, healthy living intervention for children with overweight and obesity and their families: a 'real world' trial protocol using a randomised wait list control design. Liu, S., Marques, IG., Perdew, MA., et al.[2020]

A study involving 60 obese children aged 6-11 years showed that a family-based approach, where parents were the sole agents of change, was more effective in reducing parental overweight compared to a program focused only on children.

This parent-targeted intervention also led to improved cardiovascular risk factors for both parents and children, highlighting the benefits of involving parents in obesity treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of treatment for childhood obesity on parental risk factors for cardiovascular disease. Golan, M., Weizman, A., Fainaru, M.[2016]

In a multicenter randomized controlled trial involving families with at least one overweight parent and a healthy child, changes in the mother's body mass index (BMI) were positively associated with changes in the BMI-for-age Z-scores of both children, indicating that parental weight management can influence children's weight outcomes.

The study highlights the effectiveness of family-based dietary interventions for weight maintenance, suggesting that including parents in these programs can benefit children's weight management, regardless of the child's initial weight status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of changes in body mass index and metabolic parameters between adults with overweight or obesity and their children in a family-based randomized trial (DiOGenes). Pang, MD., Yilmaz, H., Astrup, A., et al.[2022]

Family-based interventions for childhood obesity have shown moderate to large effects on reducing children's BMI, indicating their effectiveness in weight management.

Most studies reported sustainable changes in child BMI over the long term, suggesting that involving families in obesity treatment can lead to lasting improvements in children's health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-Based Interventions Targeting Childhood Obesity: A Meta-Analysis. Berge, JM., Everts, JC.[2018]

A comprehensive family-individual-school-based intervention model significantly reduced the prevalence of overweight and obesity among first-grade students in Shanghai, with a decline from 28.92% to 24.77% over three years in the intervention group.

The intervention group showed lower odds of developing obesity and decreased average BMI z-scores compared to the control group, highlighting the effectiveness of this approach in managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of multiple interventions for childhood obesity in China. Cao, ZJ., Wang, SM., Chen, Y.[2015]

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Family Intervention to Prevent Childhood Obesity

The proposed work will use a randomized study design to evaluate the impact a family-based early childhood obesity intervention for Latino families that ...