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Completed

NCT Number: NCT03841123

Effectiveness of a Dietary Counseling to Prevent Early Consumption of Added Sugar and Ultra-processed Foods

The purpose of the study is to prevent the early introduction of added sugar and ultra-processed foods and evaluate the impact on breastfeeding duration, complementary feeding quality, growth and prevalence of caries during the first year of life.

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Key information

Conditions

Infant Nutrition Disorders Behavior Behavior, Animal Feeding Behavior Feeding Patterns Health Knowledge, Attitudes, Practice Nutrition Disorders Nutritional and Metabolic Diseases

Age range

1 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Health Science of Porto Alegre

Porto Alegre, Centro Histórico, 90050-170, Brazil

About this study

This randomized field trial will be performed at the maternity wards of Friendly Hospitals Initiative in three regions of Brazil: North, Northeast and South. After delivery, mothers who accepted to participate in the study will be randomized into control and intervention groups.It will be performed a weekly block randomization to prevent the contamination of information among mothers of different groups in the same facility. The intervention mothers will be advised not to give added sugar and ultra-processed foods during the first year of life, including a leaflet with colored images as a reminder for mothers. The control group mothers will not receive the study intervention but will be have all the routine health assistance of the maternity. At 6 months and 12 months, mothers of both groups will be visited in their homes and dietary evaluation and anthropometric measurements of their babies will be assessed. At 12 months of age the infants will have dental examinations and hemoglobin concentration through a capillary blood test.

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Newborns with gestational age ≥ 37 weeks
  • single birth
  • Mother with at least 18 years old

Exclusion criteria

  • Mothers with HIV or HTLV1 positive
  • Infants with clinical occurrences or other conditions that prohibit breastfeeding or requires specific dietary treatment.

Treatment and study plan

Dietary Counseling

Other

The intervention will consist of an individualized, face-to-face, 20 to 30 minute counseling session to mothers by trained health workers who will address healthy eating practices during the first two years of life. A printed, colorful and illustrated material will be used to assist mothers in appropriate food choices, mainly to avoid the introduction of sugar and ultra-processed foods. In addition, they will receive a booklet which addresses the "Ten Steps of Healthy Feeding for children from Birth to Two years of life". The research team will focus on Step2: "Do not give added sugar or foods with added sugar", and Step8:"Do not offer ultra-processed foods as candies and soft drinks". To reinforce the intervention, mothers will receive telephone calls up to the infant reach six months.

Primary outcomes

  1. Amount of Added Sugar and ultra-processed foods consumed at 6 months

    Time frame: 6 months

    Information will be obtained through two not consecutive dietary 24 hour recall

  2. Amount of Added Sugar and ultra-processed foods consumed at 12 months

    Time frame: 12 months

    Information will be obtained through two not consecutive dietary 24 hour recall

  3. weight gain pattern at 6 months

    Time frame: 6 months

    Weight at birth and six months will be obtained and the weight gain velocity will be calculated

  4. weight gain pattern at 12 months

    Time frame: 12 months.

    Weight at six months and 12 months will be obtained and the weight gain velocity will be calculated

  5. Number of Participants with dental caries

    Time frame: 12 months

    The dental examination will be performed by dentists

  6. Anemia prevalence

    Time frame: 12 months

    The hemoglobin levels will be obtained by capillary blood tests

  7. Exclusive breastfeeding duration

    Time frame: 6 months

    Proportion of infants from 0-6 months at age who are fed exclusively with breastfeeding

  8. Prevalence of continued breastfeeding at 1 year

    Time frame: 12 months

    Proportion of children 12 months of age who are breastfed

Secondary outcomes

  1. Minimally processed foods, processed foods and total energy intake consumed at 6 months

    Time frame: 6 months

    Information will be obtained through two not consecutive dietary 24 hour recall

  2. Minimally processed foods, processed foods and total energy intake consumed at 12 months

    Time frame: 12 months

    Information will be obtained through two not consecutive dietary 24 hour recall

  3. Offer of added sugar and ultra-processed foods at 6 months

    Time frame: 6 months

    Information will be obtained through a food introduction questionnaire

  4. Offer of added sugar and ultra-processed foods at 12 months

    Time frame: 12 months

    Information will be obtained through a food introduction questionnaire

  5. Proportion of infants from 0-12 months of age who are fed with infant formula, cow's milk and toddler milk

    Time frame: 12 months

    Information will be obtained through a food introduction questionnaire

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Collaborators

  • Federal University of Amazonas
  • Federal University of Bahia
  • Ministry of Health, Brazil

Registry information

Official study title

Effectiveness of a Dietary Counseling to Prevent Added Sugar and Ultra-processed Foods During the First Year of Life: a Randomized Field Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Feb 15, 2019
Registry last updated
Mar 13, 2024

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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