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Trial record 3 of 350 for:    Recruiting, Not yet recruiting, Available Studies | "nutrition disorders" | Child

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

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ClinicalTrials.gov Identifier: NCT03841123
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Ministry of Health, Brazil
Federal University of Bahia
Federal University of Amazonas
Information provided by (Responsible Party):
Marcia Regina Vitolo, Federal University of Health Science of Porto Alegre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infant Nutrition Disorders Feeding Patterns Health Knowledge, Attitudes, Practice Other: Dietary Counseling Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of a Dietary Counseling to Prevent Added Sugar and Ultra-processed Foods During the First Year of Life: a Randomized Field Trial
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
At the maternity wards mothers will receive dietary counseling and leaflets as a reminder to prevent the early introduction of added sugar and ultra-processed foods.
Other: Dietary Counseling
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.

No Intervention: Control
At the maternity wards mothers assigned to control groups will have all the health assistance related to the maternity routine without any interference from the study protocol.



Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841123


Contacts
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Contact: Márcia Vitolo, PhD +555133038798 marciavitolo@hotmail.com

Locations
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Brazil
Federal University of Health Science of Porto Alegre Recruiting
Porto Alegre, Centro Histórico, Brazil, 90050-170
Contact: Marcia Vitolo, PhD    +555133038798    marciavitolo@hotmail.com   
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Ministry of Health, Brazil
Federal University of Bahia
Federal University of Amazonas
Investigators
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Principal Investigator: Marcia R Vitolo, PhD Federal University of Health Science of Porto Alegre

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Responsible Party: Marcia Regina Vitolo, Professor, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT03841123     History of Changes
Other Study ID Numbers: UFCSPA-RS
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Under Discussion

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marcia Regina Vitolo, Federal University of Health Science of Porto Alegre:
complementary feeding
added sugar
ultra-processed foods
intervention
infants
Additional relevant MeSH terms:
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Nutrition Disorders
Infant Nutrition Disorders