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临床试验/NCT04262102
NCT04262102进行中(未招募)不适用

A Quasi-experimental Approach to Characterize the Factors That Influence the Acceptance of New Foods by Infants: Mothers' Diet and Weaning Method: The Dastatuz Project

University of the Basque Country (UPV/EHU)4 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2019年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
384
试验地点
4
主要终点
Change of fruit and vegetable intake

研究概览

简要总结

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.

详细描述

A quasi-experimental, multicentre, controlled and prospective intervention study is proposed. Guidelines from the TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) statement for non-randomised control trials on behavioural and public health interventions will be followed meticulously in order to follow a realistic scenario which could be easily reproduced onwards. Initially, mothers in the third trimester of pregnancy (n=384) will be assigned to different diet profiles according to their own food preferences (Standard diet, SD vs. High Fruit and Vegetable diet, HFV); next, caregivers' willingness to perform weaning following one or other approach will be the base to establish groups (Spoon feeding, SF vs. Baby Led Weaning, BLW, respectively). Regardless of their distribution, all of them will receive the current standard recommendations and care. Intervention groups will receive additional diet recommendations during pregnancy, breastfeeding and weaning. The study implies a time period from the third trimester of the pregnancy until children are 18 months old. Follow-up, sampling and/or measurements will be performed at 6-7th months of pregnancy, before delivery; 2nd, 4th, 6th, 12th and 18t months from birth. Moreover, 5-6 meetings are going to be held either at the Outpatient Consultation of the Txagorritxu Hospital (Vitoria-Gasteiz) or at the Faculty of Psychology of the University of the Basque Country (Donostia-San Sebastian), where material and information are going to be given to the participants.

Procedure Baseline questionnaire and dietary assessment will be the base for group blind assignment. Those below the national (Spain) mean consumption of fruits and vegetable (about 414 g/person/day) or/and those who claim to have difficulties achieving the recommended portions will be included in the control group (SD, see arms of the intervention). When a fruit consumption of one standard deviation bellow the mean is detected, dietetic assessment will be performed in order to encourage, at least, the mean intake. Those above the national (Spain) mean consumption of fruits and vegetable (about 414 g/person/day) will be included in the experimental group (HFV, see arms of the intervention). During the study, they will be encouraged and assessed to achieve even a higher intake, 800 g/person/day. If a significant FV decrease in their diet is detected in the follow-ups, dietetic assessment will be performed in order to restore the initial intake. For weaning groups, those better disposed to follow a spoon-feeding approach will be included in the control group (SF, see arms of the intervention); and those better disposed to follow a baby-led approach will be included in the intervention group (BLW, see arms of the intervention).

Several measuring tools are proposed to obtain objective data along the designed project:

QUESTIONNAIRES

  • Q1: Participants will complete this questionnaire during recruitment and it will collect information about their socio-economic and psychological status, her actual diet profile and her expectations about the feeding of her future baby. It will also contain a question regarding preferred contact method (email/telephone/post).
  • Q2: This is a follow-up questionnaire (completed by online questionnaires) which will assess the adherence to the diet of the mother along pregnancy. Moreover, it will also collect information about the psychological aspect, such as the parental stress level of participants.
  • q1: It is a short questionnaire on the breastfeeding efficacy that will be completed on the second week post-partum. It has been used to predict breastfeeding duration and exclusivity.
  • Q3: It is very similar to the Q2 questionnaire, but parameters will be studied during lactation.
  • Q4: This will also be a follow-up questionnaire. Although it is quite similar to Q3, this one includes a new questionnaire about parental feeding styles.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change of fruit and vegetable intake

时间窗: 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

Measured by an ad hoc questionnaire reported by parents.

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

时间窗: 6th month after delivery, 12th month after delivery, 18th month after delivery

Assessed by videotaped meals of children.

Change of diet during pregnancy and breastfeeding: predimed

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

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.

Change of diet during pregnancy and breastfeeding: precoded food record

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

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.

次要结局

  • 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)
  • Breastfeeding efficacy and certainty(Week 2 after delivery, 4th month after delivery)
  • Acceptance of novel foods (1)(6th month after delivery, 12th month after delivery, 18th month after delivery)
  • Composition profile of mother´s milks (2)(2nd month after delivery)
  • Rheological characteristics of mother´s milks(2nd month after delivery)
  • Adherence to the diet assigned to each group(8-9th month of pregnancy, 4th month after delivery)
  • Children BMI from birth(6th, 9th and 12th months after birth, following the paediatric callendar.)
  • Mother's psychological state regarding pregnancy(Baseline)
  • Maternal anxiety(Baseline, 8th-9th month of pregnancy, 4th month after delivery, 6th month after delivery)
  • Parental feeding styles(6th month after delivery, 12th month after delivery, 18th month after delivery)
  • Composition profile of mother´s milks (1)(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)
  • Level of depression(Baseline, 8th-9th month of pregnancy, 4th month after delivery, 6th month after delivery)
  • Acceptance of novel foods (2)(6th month after delivery, 12th month after delivery, 18th month after delivery)

研究者

发起方
University of the Basque Country (UPV/EHU)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olaia Martinez Gonzalez

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).

University of the Basque Country (UPV/EHU)

研究点 (4)

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