The Dastatuz Project

NCT04262102 | Unknown

• 1 other identifier: DAST2019
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 2

Brief Summary

Unhealthy eating habits are a social challenge in this century, regarding that children usually refuse to eat and taste fruits and vegetables. The Dastatuz project aims to study children food neophobia (the term used referring the reluctance to taste new foods) and fruit and vegetables acceptance. It pretends to tackle the issue from an early stage: pregnancy, lactation and complementary feeding. In this sense, the Project aspires to assess the possible impact of maternal diet and complementary feeding on young children eating behaviour until 18 months of age. In addition, it intends to study the effect that the type of complementary feeding (spoon-fed or baby-led) might have on that eating behaviour. Considering these objectives, a quasi-experimental, multicenter, controlled and prospective intervention study is proposed. If it proved to be effective, this experience would have a high potential to be transferred and would open the possibility to give way to future public programs or guidelines, as a basic and easy solution to achieve higher fruit and vegetable intake among children and, consequently, the potential health benefits this may bring. Besides, taking into consideration the above mentioned ideas, the investigators hypothesized that a high intake and variety of fruit and vegetables (FV) during pregnancy and breastfeeding will lead to distinctive sensorial experiences for the baby, different from those of the babies whose mothers following a "standard diet" (as described in the National Nutrition Surveys). This consumption profile will promote the acceptance of fruits and vegetables along complementary feeding. Additionally, a correct baby-led weaning (BLW) may also contribute to establish these healthy eating habits.

Conditions

Food Preferences; Food Habits; Food Selection

Keywords

Children food neophobia; Fruit and vegetables; Mother's diet; Breastfeeding; Baby-led weaning; Spoon feeding; Nutrition; Weaning

Outcome Measures

Primary Outcomes (4)

• Change of diet during pregnancy and breastfeeding: predimed

  This possible change will be measured using Predimed questionnaire (Martínez-González et al., 2012), which has 14 items that evaluate adherence to the Mediterranean Diet. Each of the items has a different criterion to get a point, being 0 the minimum and 14 maximum of the total score. If total score is ≤7, it means low adherence; if total score is \>7, it means high adherence.

  Baseline, 8-9th month of pregnancy, 4th month after delivery, 6th month after delivery

• Change of diet during pregnancy and breastfeeding: precoded food record

  This possible change will be measured using Pre-coded Food Record Form (Rodriguez et al., 2014), which gives information about the intake of foods in portions per day.

  Baseline, 8-9th month of pregnancy, 4th month after delivery, 6th month after delivery

• Change of fruit and vegetable intake

  Measured by an ad hoc questionnaire reported by parents.

  Beginning of the weaning process (it will depend upon each participant, from 4th month to 6th month), 6th month after delivery, 12th month after delivery, 18th month after delivery

• Change of food acceptance of exposed fruits and vegetables as the measurement of willingness to eat them

  Assessed by videotaped meals of children.

  6th month after delivery, 12th month after delivery, 18th month after delivery

Secondary Outcomes (14)

• Composition profile of mother´s milks (1)

  2nd month after delivery

• Composition profile of mother´s milks (2)

  2nd month after delivery

• Rheological characteristics of mother´s milks

  2nd month after delivery

• Child´s diet profile

  Beginning of the weaning process (it will depend upon each participant, from 4th month to 6th month), 6th month after delivery, 12th month after delivery, 18th month after delivery

• Child´s nutritional state

  Beginning of the weaning process (it will depend upon each participant, from 4th month to 6th month), 6th month after delivery, 12th month after delivery, 18th month after delivery

Study Arms (4)

Group 1 (SD_SF)

ACTIVE COMPARATOR

Women will follow a personalized standard diet, described in National Diet Surveys. And their children will be spoon-fed during complementary feeding.

Behavioral: SD_SF

Group 2 (SD_BLW)

EXPERIMENTAL

Women will follow a personalized standard diet, described in National Diet Surveys. And their children will follow a baby-led weaning approach for complementary feeding.

Behavioral: SD_BLW

Group 3 (HFV_SF)

EXPERIMENTAL

Women will follow personalized diet, high in fruits and vegetables. And their children will be spoon-fed during complementary feeding.

Behavioral: HFV_SF

Group 4 (HFV_BLW)

EXPERIMENTAL

Women will follow personalized diet, high in fruits and vegetables. And their children will follow a baby-led weaning approach for complementary feeding.

Behavioral: HFV_BLW

Interventions

SD_SF BEHAVIORAL

Women will follow a personalized standard diet, described in National Diet Surveys. And their children will be spoon-fed during complementary feeding.

Group 1 (SD_SF)

SD_BLW BEHAVIORAL

Women will follow a personalized standard diet, described in National Diet Surveys. And their children will follow a baby-led weaning approach for complementary feeding.

Group 2 (SD_BLW)

HFV_SF BEHAVIORAL

Women will follow personalized diet, high in fruits and vegetables. And their children will be spoon-fed during complementary feeding.

Group 3 (HFV_SF)

HFV_BLW BEHAVIORAL

Women will follow personalized diet, high in fruits and vegetables. And their children will follow a baby-led weaning approach for complementary feeding.

Group 4 (HFV_BLW)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy mothers who are notified about the study (and express interest to take part) before week 24 of gestation.
• Spanish, Basque or English speakers.
• Intention to live in the Basque Country until the child will be 18 months old.
• Age: 18-45 years.

You may not qualify if:

• Unhealthy mother or complicated pregnancy (all types of diabetes mellitus, high blood pressure, etc.).
• Not willing to breastfeed.
• Mother with too much diet restrictions and detection of severe non-adherence to the diet prescribed and any condition contraindicated for the development of the project.
• After birth, women will be excluded if:
• Their infant is born before 37 weeks gestation
• Their infant is born with a congenital abnormality, physical condition, or intellectual disability, which was likely to affect the infant's feeding or growth is identified.
• Also, there will not be any milk collection from mothers who are taking any medication.

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead
• Basque Government Department of Public Health: collaborator
• Bioaraba Health Research Institute: collaborator
• Biodonostia Health Research Institute: collaborator
• Biobizkaia Health Research Institute: collaborator

Study Sites (2)

Pharmacy and Food Science Department of the Basque Country/Basque Country University (Universidad del País Vasco, UPV/EHU).

Vitoria-Gasteiz, Spain/Alava, 01006, Spain

Location

and Department of Personality Assessment and Psychological Treatments of the Faculty of Psychology of the University

Donostia / San Sebastian, Spain/Guipuzcoa, 20018, Spain

Location

Related Publications (1)

• Urkia-Susin I, Rada-Fernandez de Jauregui D, Orruno E, Maiz E, Martinez O. A quasi-experimental intervention protocol to characterize the factors that influence the acceptance of new foods by infants: mothers' diet and weaning method. Dastatuz project. BMC Public Health. 2021 May 13;21(1):918. doi: 10.1186/s12889-021-10967-7.

  PMID: 33985471 DERIVED

MeSH Terms

Conditions

Food Preferences; Feeding Behavior; Breast Feeding

Condition Hierarchy (Ancestors)

Behavior; Behavior, Animal

Study Officials

• Olaia Martinez Gonzalez, PhD

  University of the Basque Country/ Basque Country University

  PRINCIPAL INVESTIGATOR

• Edurne Maiz Aldalur, PhD

  University of the Basque Country/ Basque Country University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinding. Participants will not know in which dietary group they belong to (Standard diet or High fruit and vegetable diet). We will give them dietary advice depending on their eating habits.
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor at the Department of Pharmacy and Food Science of the Faculty of Pharmacy at the University of the Basque Country (Universidad del País Vasco, EHU/UPV).

Model Details: After completing the first questionnaire, researchers will allocate each participant into one of the groups (standard diet or high fruit and vegetable diet) depending on their eating habits. Then, when participants' children start with the complementary feeding (spoon-fed or baby-led) chosen by their parents, two new groups will be created. Participants will be allocated to those two new groups depending on the complementary feeding style they have chosen for their children. Therefore, the study will follow the factorial model, created by the following groups: standard diet and spoon-feeding (group 1), standard diet and baby-led weaning (group 2), high fruit and vegetable diet and spoon-feeding (group 3), and high fruit and vegetable diet and baby-led weaning (group 4).

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: February 10, 2020
• Study Start: October 18, 2019
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

ES (2)