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
|Condition or disease||Intervention/treatment||Phase|
|Infant Nutrition Disorders Feeding Patterns Health Knowledge, Attitudes, Practice||Other: Dietary Counseling||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||504 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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
- 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
- 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
- Number of Participants with dental caries [ Time Frame: 12 months ]The dental examination will be performed by dentists
- Anemia prevalence [ Time Frame: 12 months ]The hemoglobin levels will be obtained by capillary blood tests
- Exclusive breastfeeding duration [ Time Frame: 6 months ]Proportion of infants from 0-6 months at age who are fed exclusively with breastfeeding
- Prevalence of continued breastfeeding at 1 year [ Time Frame: 12 months ]Proportion of children 12 months of age who are breastfed
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
|Contact: Márcia Vitolo, PhDfirstname.lastname@example.org|
|Federal University of Health Science of Porto Alegre||Recruiting|
|Porto Alegre, Centro Histórico, Brazil, 90050-170|
|Contact: Marcia Vitolo, PhD +555133038798 email@example.com|
|Principal Investigator:||Marcia R Vitolo, PhD||Federal University of Health Science of Porto Alegre|