Effectiveness of a Dietary Counseling to Prevent Early Consumption of Added Sugar and Ultra-processed Foods
Primary Purpose
Infant Nutrition Disorders, Feeding Patterns, Health Knowledge, Attitudes, Practice
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dietary Counseling
Sponsored by
About this trial
This is an interventional prevention trial for Infant Nutrition Disorders focused on measuring complementary feeding, added sugar, ultra-processed foods, intervention, infants
Eligibility 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.
Sites / Locations
- Federal University of Health Science of Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Amount of Added Sugar and ultra-processed foods consumed at 6 months
Information will be obtained through two not consecutive dietary 24 hour recall
Amount of Added Sugar and ultra-processed foods consumed at 12 months
Information will be obtained through two not consecutive dietary 24 hour recall
weight gain pattern at 6 months
Weight at birth and six months will be obtained and the weight gain velocity will be calculated
weight gain pattern at 12 months
Weight at six months and 12 months will be obtained and the weight gain velocity will be calculated
Number of Participants with dental caries
The dental examination will be performed by dentists
Anemia prevalence
The hemoglobin levels will be obtained by capillary blood tests
Exclusive breastfeeding duration
Proportion of infants from 0-6 months at age who are fed exclusively with breastfeeding
Prevalence of continued breastfeeding at 1 year
Proportion of children 12 months of age who are breastfed
Secondary Outcome Measures
Full Information
NCT ID
NCT03841123
First Posted
December 18, 2018
Last Updated
August 18, 2021
Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Ministry of Health, Brazil, Federal University of Bahia, Federal University of Amazonas
1. Study Identification
Unique Protocol Identification Number
NCT03841123
Brief Title
Effectiveness of a Dietary Counseling to Prevent Early Consumption of Added Sugar and Ultra-processed Foods
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
February 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Ministry of Health, Brazil, Federal University of Bahia, Federal University of Amazonas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Nutrition Disorders, Feeding Patterns, Health Knowledge, Attitudes, Practice
Keywords
complementary feeding, added sugar, ultra-processed foods, intervention, infants
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
516 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary Counseling
Intervention Description
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 Outcome Measure Information:
Title
Amount of Added Sugar and ultra-processed foods consumed at 6 months
Description
Information will be obtained through two not consecutive dietary 24 hour recall
Time Frame
6 months
Title
Amount of Added Sugar and ultra-processed foods consumed at 12 months
Description
Information will be obtained through two not consecutive dietary 24 hour recall
Time Frame
12 months
Title
weight gain pattern at 6 months
Description
Weight at birth and six months will be obtained and the weight gain velocity will be calculated
Time Frame
6 months
Title
weight gain pattern at 12 months
Description
Weight at six months and 12 months will be obtained and the weight gain velocity will be calculated
Time Frame
12 months.
Title
Number of Participants with dental caries
Description
The dental examination will be performed by dentists
Time Frame
12 months
Title
Anemia prevalence
Description
The hemoglobin levels will be obtained by capillary blood tests
Time Frame
12 months
Title
Exclusive breastfeeding duration
Description
Proportion of infants from 0-6 months at age who are fed exclusively with breastfeeding
Time Frame
6 months
Title
Prevalence of continued breastfeeding at 1 year
Description
Proportion of children 12 months of age who are breastfed
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcia R Vitolo, PhD
Organizational Affiliation
Federal University of Health Science of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Health Science of Porto Alegre
City
Porto Alegre
State/Province
Centro Histórico
ZIP/Postal Code
90050-170
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Under Discussion
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Effectiveness of a Dietary Counseling to Prevent Early Consumption of Added Sugar and Ultra-processed Foods
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