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Completed

NCT Number: NCT00629629

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

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.

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Key information

Conditions

Anemia Behavior Body Weight Breast Feeding Breast Feeding, Exclusive Feeding Behavior Feeding and Eating Disorders Feeding and Eating Disorders of Childhood Hematologic Diseases Hemic and Lymphatic Diseases Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Household

São Leopoldo, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary Advice

Behavioral

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.

Primary outcomes

  1. Effectiveness of a nutrition advice programme in exclusive breastfeeding.

    Time frame: 1 year

    Group difference in months of esclusive breastfeeding

  2. Effectiveness of a nutrition advice programme in dietary intake

    Time frame: 1 year

    Group differences in energy, fats, protein, carbohidrates and micronutrients intake

  3. Effectiveness of a nutrition advice programme in dietary intake

    Time frame: 4 years

    Group differences in energy, fats, protein, carbohidrates and micronutrients intake

  4. Effectiveness of a nutrition advice programme in dietary intake

    Time frame: 8 years

    Group differences in energy, fats, protein, carbohidrates and micronutrients intake

  5. Effectiveness of a nutrition advice programme in dietary intake

    Time frame: 12 years

    Group differences in energy, fats, protein, carbohidrates and micronutrients intake

Secondary outcomes

  1. Effectiveness of a nutrition advice programme in occurrence of diarrhea, respiratory problems, use of medication, dental caries,anemia and hospitalization.

    Time frame: 1 year

    Group differences in the % of children with each condition

  2. Effectiveness of a nutrition advice programme in nutritional status

    Time frame: 1 year

    Group differences in the % of overweight and obese children.

  3. Effectiveness of a nutrition advice programme in nutritional status

    Time frame: 4 years

    Group differences in the % of overweight and obese children.

  4. Effectiveness of a nutrition advice programme in nutritional status

    Time frame: 8 Years

    Group differences in the % of overweight and obese children.

  5. Effectiveness of a nutrition advice programme in nutritional status

    Time frame: 12 Years

    Group differences in the % of overweight and obese children.

  6. Salty taste preferences

    Time frame: 12 years

    Evaluate the most preferred concentration of salt

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Important dates

Study start
2001
Primary completion
2002
Study completion
2015
First posted
Mar 6, 2008
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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