Obesity, ChildhoodNCT06398509
A Primary Care Based Intervention to Prevent Childhood Obesity Among Low-income Latino Children
A study testing Futuros Fuertes 2.0 in people with Obesity, Childhood, run by University of California, San Francisco at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 days to 2 months
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Futuros Fuertes 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 May 2024to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent/caregiver self identifies as Latino
- Parent/caregiver speaks Spanish or English
- Parent/caregiver intends to receive primary care for infant at participating clinic
- Infant gestational age of 37 weeks or greater
- Infant birthweight of 2600 grams or greater
- For multiples (twins, triplets), one sibling will be chosen at random to participate
Who cannot join
- -Infant has a serious medical condition that affects feeding or growth
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Children's Health Center San Francisco General Hospital
San Francisco, California, 94110
Amy Beck, MD MPH
- Recruiting
Valley Health Center Sunnyvale
Sunnyvale, California, 94086
Amy Beck, 415-476-3368, amy.beck@ucsf.edu
About this study
Official title: Futuros Fuertes 2.0 A Primary Care Based Intervention to Prevent Obesity Among Low-income Latino Children
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.
- Conditions
- Obesity, Childhood
- Being tested
- Control, Futuros Fuertes 2.0
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
The control intervention includes brief health education and coaching sessions just after well child visits in the first two years of life (total of 7 sessions), 2 text messages per week for the primary caregiver and up to two additional family members, and environmental prompts that support healthy behaviors. The control intervention focuses on home safety, home management of common childhood illnesses, and promotion of language development.
Futuros Fuertes 2.0Behavioural
The Futuros Fuertes 2.0 intervention includes brief health education and coaching sessions just after well child visits in the first two years of life (total of 7 sessions), 2 text messages per week for the primary caregiver and up to two additional family members, and environmental prompts that support healthy behaviors. The Futuros Fuertes 2.0 intervention focuses on optimal infant feeding, screen time, and sleep practices.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Futuros Fuertes 2.0 |
| Control | Active comparator | 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI Z-score
BMI Z-score based on WHO growth curves
Measured: 24-months
Secondary outcomes (6)
Breastfeeding
Duration of breastfeeding in first year of life
Measured: First year of life
Screen time
Daily screen time
Measured: 24-months
Sleep duration
Daily sleep duration
Measured: 24-months
Fruit and vegetable intake
Daily fruit and vegetable intake
Measured: 24-months
Sugar sweetened beverage and 100% fruit juice intake
Weekly ounces of sugar-sweetened beverages and 100% fruit juice
Measured: 24-months
Change in BMI Z-score
Trajectory of BMI Z-score (WHO growth curve)
Measured: 6-months to 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start13 May 2024
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Amy Beck, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398509
- Sponsor's protocol ID
- 23-38707
- Other IDs
- 1R01HD109158
- Status last verified
- Apr 2026
- First submitted
- 1 May 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of the study, final research data will be available for use by other investigators, federal agencies, or other appropriate organizations or personnel upon request. Research data will be shared in a de-identified data set to protect subject privacy.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Futuros Fuertes 2.0 A Primary Care Based Intervention to Prevent Obesity Among Low-income Latino Children
- ClinicalTrials.gov ID
- NCT06398509
- Acronym / sponsor ID
- 23-38707
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 13 May 2024 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Futuros Fuertes 2.0The 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. |
| Control | Active comparator | Behavioral: ControlThe 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 may qualify
- Ages
- 7 days to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Parent/caregiver self identifies as Latino
- Parent/caregiver speaks Spanish or English
- Parent/caregiver intends to receive primary care for infant at participating clinic
- Infant gestational age of 37 weeks or greater
- Infant birthweight of 2600 grams or greater
Key exclusion criteria (1 listed)
- -Infant has a serious medical condition that affects feeding or growth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlThe control intervention includes brief health education and coaching sessions just after well child visits in the first two years of life (total of 7 sessions), 2 text messages per week for the primary caregiver and up to two additional family members, and environmental prompts that support healthy behaviors. The control intervention focuses on home safety, home management of common childhood illnesses, and promotion of language development. | Behavioural | Control |
| Futuros Fuertes 2.0The Futuros Fuertes 2.0 intervention includes brief health education and coaching sessions just after well child visits in the first two years of life (total of 7 sessions), 2 text messages per week for the primary caregiver and up to two additional family members, and environmental prompts that support healthy behaviors. The Futuros Fuertes 2.0 intervention focuses on optimal infant feeding, screen time, and sleep practices. | Behavioural | Intervention |
Primary outcome
BMI Z-score
Time frame: 24-months
BMI Z-score based on WHO growth curves
6 secondary outcomes
Breastfeeding
Time frame: First year of life
Screen time
Time frame: 24-months
Sleep duration
Time frame: 24-months
Fruit and vegetable intake
Time frame: 24-months
Sugar sweetened beverage and 100% fruit juice intake
Time frame: 24-months
Change in BMI Z-score
Time frame: 6-months to 24-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Yes. After completion of the study, final research data will be available for use by other investigators, federal agencies, or other appropriate organizations or personnel upon request. Research data will be shared in a de-identified data set to protect subject privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Beck, MD, MPH principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Futuros Fuertes 2.0 in people with Obesity, Childhood, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Beck, MD, MPH (415-476-3368, amy.beck@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI Z-score (time frame: 24-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.