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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD109158 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| BMI Z-score | BMI Z-score based on WHO growth curves | 24-months |
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding | Duration of breastfeeding in first year of life | First year of life |
| Screen time | Daily screen time | 24-months |
| Measure | Description | Time Frame |
|---|---|---|
| Screen time | Daily screen time | 6-months, 12-months and 18-months |
| Sleep duration | Daily sleep duration | 6-months, 12-months, 18-months |
Inclusion Criteria:
Exclusion Criteria:
-Infant has a serious medical condition that affects feeding or growth
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Beck, MD, MPH | Contact | 415-476-3368 | amy.beck@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amy Beck, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Health Center San Francisco General Hospital | Recruiting | San Francisco | California | 94110 | United States |
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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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Futuros Fuertes 2.0 | Behavioral | 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. |
|
| Sleep duration | Daily sleep duration | 24-months |
| Fruit and vegetable intake | Daily fruit and vegetable intake | 24-months |
| Sugar sweetened beverage and 100% fruit juice intake | Weekly ounces of sugar-sweetened beverages and 100% fruit juice | 24-months |
| Change in BMI Z-score | Trajectory of BMI Z-score (WHO growth curve) | 6-months to 24-months |
| Sugar-sweetened beverages and 100% fruit juice | Weekly ounces of sugar-sweetened beverages and 100% fruit juice | 6-months, 12-months, 18-months |
| Valley Health Center Sunnyvale | Recruiting | Sunnyvale | California | 94086 | United States |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |