Health Education Program for Childhood Obesity

Recruiting at 1 trial location

Overseen By Amy Beck, MD, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Serious medical condition

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

Compensation: Varies

Number of Visits: Unknown

576 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how health education for parents can improve feeding, screen time, and sleep habits in young children to help manage childhood obesity. Half of the participants will receive the Futuros Fuertes 2.0 program, which provides guidance on these habits during doctor visits and weekly health tips via text. The other half will focus on safety, illness management, and language development. The trial seeks Latino parents with infants born healthy at 37 weeks or later, who plan to receive primary care at specific clinics.

As an unphased trial, this study offers parents a unique opportunity to contribute to important research that could shape future health education programs.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this health education program is safe for infants and toddlers?

Research shows that the Futuros Fuertes 2.0 program is generally manageable for participants. Past studies on similar programs that teach health and lifestyle habits to young children have not reported major negative effects. These programs typically offer advice on healthy habits like eating, screen time, and sleep, which are safe and beneficial.

Because this study involves health education and coaching rather than medication or medical procedures, the risk of side effects remains very low. Participants receive useful tips and support to encourage healthier lifestyles, which have shown positive results in similar programs without safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Futuros Fuertes 2.0 program for childhood obesity because it offers a comprehensive approach that combines personalized health education with ongoing support, something current standard options often lack. Unlike other treatments that may focus solely on diet or exercise, this program integrates optimal feeding practices, screen time management, and sleep habits into early childhood care. Additionally, it leverages modern technology by providing caregivers with regular text messages and environmental prompts to reinforce healthy behaviors at home, making it a potentially more engaging and sustainable solution.

What evidence suggests that the Futuros Fuertes 2.0 intervention could be effective for childhood obesity?

Research has shown that the Futuros Fuertes 2.0 program, which participants in this trial may receive, can help low-income Latino infants develop healthier habits. In earlier studies, children in this program demonstrated slightly better eating and screen time habits compared to those not in the program. Specifically, they likely ate healthier foods and spent less time in front of screens. The program offers health education and coaching to assist families in improving feeding, screen time, and sleep practices. Although the changes are small, they suggest this approach could help manage childhood obesity. ^{1 6 7 8 9}

Who Is on the Research Team?

Amy L Beck, MD, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

The Futuros Fuertes 2.0 trial is for low-income Latino infants and toddlers, aiming to promote healthy feeding, screen time, and sleep practices. Participants will receive health education and coaching at primary care visits over two years with additional supportive text messages.

Inclusion Criteria

Parent/caregiver speaks Spanish or English

For multiples (twins, triplets), one sibling will be chosen at random to participate

Infant birthweight of 2600 grams or greater

Exclusion Criteria

My infant has a serious condition impacting their feeding or growth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Futuros Fuertes 2.0 intervention or control intervention, including health education and coaching at well child visits, and weekly text messages for two years

24 months

Regular well child visits

Follow-up

Participants are monitored for changes in BMI Z-score and health behaviors such as screen time, sleep duration, and dietary intake

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Futuros Fuertes 2.0

Trial Overview This study tests the Futuros Fuertes 2.0 intervention against a control group focusing on safety and language development. The main goal is to see if tailored health coaching can improve child BMI and health behaviors in the intervention group.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The Futuros Fuertes 2.0 intervention includes brief health education and coaching at well child visits in the first two years of life that addresses optimal feeding, screen time and sleep practices. In addition, caregivers receive 2 text messages per week. Caregivers also receive environmental prompts to help support healthy behaviors at home.

Group II: Control Active Control 1 Intervention

The control intervention includes brief health education and coaching at well child visits in the first two years of life that addresses home safety, management of common childhood illnesses, and promotion of language development. In addition, caregivers receive 2 text messages per week. Caregivers also receive environmental prompts to help support healthy behaviors at home.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Participation in the Fit2Play™ afterschool program led to significant reductions in body mass index (BMI) percentiles for overweight and obese children, indicating effective weight management over one school year with 1546 participants.

The program also improved cardiovascular health, as evidenced by significant decreases in systolic and diastolic blood pressure, along with enhanced fitness levels and nutrition knowledge among all participants, highlighting its potential as a valuable intervention for childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a park-based afterschool program replicated over five years on modifiable cardiovascular disease risk factors. Messiah, SE., Vidot, D., Hansen, E., et al.[2022]

The adaptation of the Familias Unidas intervention for obesity prevention in Hispanic adolescents involved input from experts and families, leading to a program that emphasizes improved family health, nutrition education, and physical activity engagement.

Pilot testing showed that parents were enthusiastic about hands-on nutrition training, and adolescents expressed a desire for more joint physical activities with their parents, highlighting the importance of family involvement in obesity prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Familias Unidas for Health and Wellness: Adapting an Evidence-Based Substance Use and Sexual Risk Behavior Intervention for Obesity Prevention in Hispanic Adolescents. St George, SM., Messiah, SE., Sardinas, KM., et al.[2023]

In a 10-week school-based program involving 63 obese children aged 5 to 12, 95% of participants lost weight, achieving an average weight loss of 4.4 kg and a 15.4% decrease in their percentage overweight.

The program was significantly more effective than no intervention, as only 21% of a control group of obese children lost weight, highlighting the importance of comprehensive behavior modification and support in managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based behavior modification, nutrition education, and physical activity program for obese children. Brownell, KD., Kaye, FS.[2018]

The introduction of a Bilingual Case Manager in a pediatric weight management clinic significantly increased enrollment of Hispanic families, boosting participation over ten-fold.

Outcomes for Hispanic families in the program were equal to or better than those of other racial/ethnic groups, highlighting the effectiveness of a family-centered and culturally sensitive approach in obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting a tertiary-care pediatric weight management clinic to better reach Spanish-speaking families. Guzman, A., Irby, MB., Pulgar, C., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11627153/

A Multimethod Evaluation of the Futuros Fuertes ... We have demonstrated that a primary care-based, lay health educator led intervention to prevent childhood obesity among low-income Latino ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876285923001547

A Multimethod Evaluation of the Futuros Fuertes ... Low-income Latino infants participating in the Futuros Fuertes intervention had modestly healthier feeding and screen time practices compared to control ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06398509

UCSF Obesity Trial → Primary Care Based Intervention to ... The goal of this study is to evaluate the impact of a primary care based intervention to promote optimal feeding, screen time and sleep practices.

4. thelancet.com thelancet.com/cms/10.1016/S0140-6736(25)01144-4/attachment/079a8ad6-d0cd-405b-91b8-0fb66122ced7/mmc1.pdf

Supplementary appendix Futuros Fuertes 2.0 intervention: includes brief health education and coaching sessions just after well child visits in the first 2 yrs of ...

5. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-023-01405-5

Effectiveness of a Smartphone App (MINISTOP 2.0) integrated ... Children in the intervention group had lower intakes of sweet and savory treats, sweet drinks, less screen time (primary outcomes) and their ...

6. reporter.nih.gov reporter.nih.gov/project-details/10003235

Obesity Prevention in Head Start: The Miranos! Program Futuros Fuertes 2.0: A primary care-based intervention to prevent obesity in low-income Latino children. 1016, 5R01HD109158-03Project Numberf. BECK, AMY LAURA ...

7. escholarship.org escholarship.org/content/qt3kt3d3zn/qt3kt3d3zn_noSplash_2ecc2ddbb1bf8e945cc48a8b3dcf4ac3.pdf?t=sos6vs

A Multimethod Evaluation of the Futuros Fuertes ... Obesity and type 2 diabetes in children: epidemiology and treatment. ... intervention on childhood weight outcomes at 3 years of age: the ...

8. researchgate.net researchgate.net/publication/351175337_A_Health-Literacy_Intervention_for_Early_Childhood_Obesity_Prevention_A_Cluster-Randomized_Controlled_Trial

A Health-Literacy Intervention for Early Childhood Obesity ... The primary outcome was proportion of children overweight (BMI ≥85th percentile) at age 24 months. Secondary outcomes included weight status ( ...

9. aspe.hhs.gov aspe.hhs.gov/childhood-obesity-data-initiative-codi-integrated-data-patient-centered-outcomes-research-project-20

Childhood Obesity Data Initiative (CODI): Integrated Data ... CODI 2.0 aims to further develop the existing CODI infrastructure for linking individual pediatric-level data across systems to prepare for implementation.