Impacts of the 10 Steps for Healthy Feeding in Infants: a Randomized Field Trial

Study Overview
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Brief Summary
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This study assesses the effectiveness of a nutrition advice programme - The ten steps for healthy feeding of children under two years old - on nutritional status, diet, and morbidity history of children. This is a randomized controlled trial in mostly socioeconomic deprived families (intervention=200; controls=300). Mothers of the intervention group received dietary counseling in the first year of life. Both groups received routine care by their paediatricians and research assessment at 6 and 12 months, 4 years, 8 years and 12 years of age.

Official Title
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Impacts of the 10 Steps for Healthy Feeding in Infants: a Randomized Field Trial

Conditions
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Anemia, Breast Feeding, Exclusive, Overweight and Obesity

Intervention / Treatment
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* Behavioral: Dietary Advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newborn infants with birth weight ≥ 2.500 g and gestational age ≥ 37 weeks were considered eligible for the study. Exclusion Criteria: HIV-positive mothers Congenital malformation Infants referred to intensive care unit Multiple pregnancy.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Mothers in the intervention group received dietary advice based on Brazilian guidelines [Ten steps for the healthy eating: Feeding guidelines for Brazilian children from birth to two years ] during monthly home visits from 2 weeks to 6 months postpartum and then every 2 months thereafter until 1 y postpartum. | Behavioral: Dietary Advice<br>* Step 1 - Provide Exclusive breastfeeding up to 6 mo. Step 2- After 6 mo, gradually introduce complementary foods and continue breastfeeding up to 2 y or more. Step 3 - Complementary foods should be given 3 times a day (cereals, beans, fruits, and vegetables) if the child is breastfed, and 5 times a day if not. Step 4- Mealtimes must be adjusted to the children's cues of hunger and satiety. Step 5: Foods should gradually get thicker up to the time when the child is able to eat a family meal. Complementary foods should not be liquefied. Step 6: A large variety of healthy foods should be given daily to guarantee the intake of different nutrients. Step 7: Different fruits and vegetables should be offered daily. Step 8: Sugar, sweets, soft drinks, salty snacks, cookies, and processed and fried foods must be avoided. Step 9: Good hygiene practices in food preparation and handling. Step 10: Adequate feeding during child illness.<br>|
| No Intervention: Control<br>Mothers in the control group received routine medical assistance without any involvement of the research team. The study staff provided no materials to mothers on the Control Arm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of a nutrition advice programme in exclusive breastfeeding. | Group difference in months of esclusive breastfeeding | 1 year | 
| Effectiveness of a nutrition advice programme in dietary intake | Group differences in energy, fats, protein, carbohidrates and micronutrients intake | 1 year | 
| Effectiveness of a nutrition advice programme in dietary intake | Group differences in energy, fats, protein, carbohidrates and micronutrients intake | 4 years | 
| Effectiveness of a nutrition advice programme in dietary intake | Group differences in energy, fats, protein, carbohidrates and micronutrients intake | 8 years | 
| Effectiveness of a nutrition advice programme in dietary intake | Group differences in energy, fats, protein, carbohidrates and micronutrients intake | 12 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of a nutrition advice programme in occurrence of diarrhea, respiratory problems, use of medication, dental caries,anemia and hospitalization. | Group differences in the % of children with each condition | 1 year | 
| Effectiveness of a nutrition advice programme in nutritional status | Group differences in the % of overweight and obese children. | 1 year | 
| Effectiveness of a nutrition advice programme in nutritional status | Group differences in the % of overweight and obese children. | 4 years | 
| Effectiveness of a nutrition advice programme in nutritional status | Group differences in the % of overweight and obese children. | 8 Years | 
| Effectiveness of a nutrition advice programme in nutritional status | Group differences in the % of overweight and obese children. | 12 Years | 
| Salty taste preferences | Evaluate the most preferred concentration of salt | 12 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbidity, Health Plan Implementation, Feeding and Eating Disorders of Childhood, Breastfeeding, Complementary feeding, Anemia, Public policy