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?

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 among low-income Latino infants and toddlers. Infants and caregivers will receive brief health education and coaching sessions from health educators at primary care visits in the first two years of life as well as two text messages per week with health information and tips. Half of the participants will receive the Futuros Fuertes 2.0 intervention that includes health coaching and education on infant feeding, screen time and sleep (intervention group). The other half will receive health coaching and education on safety, home management of childhood illnesses, and promotion of language development (control group). We will look at the impact of the Futuros Fuertes 2.0 intervention on child BMI and various health behaviors.

Will I have to stop taking my current medications?

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

Is the Health Education Program for Childhood Obesity safe for children?

The Health Education Program for Childhood Obesity, including adaptations like Familias Unidas, has been tested in various forms and generally involves safe activities such as nutrition education and physical activity. Parents and children have reported positive experiences, and no safety concerns have been highlighted in the available research. ^{1 2 3 4 5}

What makes the Futuros Fuertes 2.0 treatment for childhood obesity unique?

Futuros Fuertes 2.0 is unique because it combines health education with physical activity and involves the whole family in adopting healthy habits, unlike other treatments that may focus solely on diet or exercise. It also includes culturally tailored interventions, particularly for Hispanic children, to ensure the program is relevant and effective for this community. ^{1 5 6 7 8}

What data supports the effectiveness of the treatment Futuros Fuertes 2.0 for childhood obesity?

A school-based program involving behavior modification, nutrition education, and physical activity showed significant weight loss in obese children, suggesting that similar comprehensive programs can be effective. Additionally, interventions with a parental component and culturally appropriate materials have been more successful, especially among Hispanic children. ^{1 9 10 11 12}

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

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]

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]

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]

Citations

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

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

2. England pubmed.ncbi.nlm.nih.gov

A systematic analysis of childhood obesity prevention interventions targeting Hispanic children: lessons learned from the previous decade. [2021]

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

A Novel Home-Based Intervention for Child and Adolescent Obesity: The Results of the Whānau Pakari Randomized Controlled Trial. [2018]

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

Adapting a tertiary-care pediatric weight management clinic to better reach Spanish-speaking families. [2021]

5. Mexico pubmed.ncbi.nlm.nih.gov

Interventions for the treatment of obesity among children and adolescents in Latin America: a systematic review. [2021]

6. Netherlands 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. [2023]

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

Salud America! Developing a National Latino Childhood Obesity Research Agenda. [2022]

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

Impact of a park-based afterschool program replicated over five years on modifiable cardiovascular disease risk factors. [2022]

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

Nutrition Intervention to Hispanic Groups: Pilot Studies with Children and Caregivers. [2021]

10. Spain pubmed.ncbi.nlm.nih.gov

[Education for health. Nutrition and gastronomy in the Autonomous Cities of Melilla and Ceuta]. [2022]

11. Chile pubmed.ncbi.nlm.nih.gov

[Effect of counselling school teachers on healthy lifestyle on the impact of a program to reduce childhood obesity]. [2014]

12. England pubmed.ncbi.nlm.nih.gov

Education for childhood obesity prevention across the life-course: workshop conclusions. [2021]