Food Habits Clinical Trial
— DastatuzOfficial title:
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
Verified date | February 2023 |
Source | University of the Basque Country (UPV/EHU) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 384 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | and Department of Personality Assessment and Psychological Treatments of the Faculty of Psychology of the University | Donostia-San Sebastian | Spain/Guipuzcoa |
Spain | Pharmacy and Food Science Department of the Basque Country/Basque Country University (Universidad del País Vasco, UPV/EHU). | Vitoria-Gasteiz | Spain/Alava |
Lead Sponsor | Collaborator |
---|---|
University of the Basque Country (UPV/EHU) | Basque Government Department of Public Health, Bioaraba Health Research Institute, Biocruces Bizkaia Health Research Institute, Biodonostia Health Research Institute |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Composition profile of mother´s milks (1) | Measured by Infrared Spectroscopy MilkoScan (Foss Electric, Denmark) to measure nutritional composition of the milk samples (mg nutrient/100 mL). | 2nd month after delivery | |
Secondary | Composition profile of mother´s milks (2) | Measured by Gas chromatographic- mass spectrometry (GC-MS) to measure aromatic profile of the milk samples (ppm). | 2nd month after delivery | |
Secondary | Rheological characteristics of mother´s milks | Measured by Rheometry techniques (rheometer AR1000, TA Instruments) to measure apparent viscosity in (mPa•s). | 2nd month after delivery | |
Secondary | Child´s diet profile | Measured by 24h dietary recall 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 | |
Secondary | Child´s nutritional state | Assessed by the periodical paediatric control, reported then 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 | |
Secondary | Adherence to the diet assigned to each group | Measured by Pre-coded Food Record Form (Rodriguez et al., 2014). | 8-9th month of pregnancy, 4th month after delivery | |
Secondary | Children BMI from birth | Assessed by the periodical paediatric control, reported then by parents. | 6th, 9th and 12th months after birth, following the paediatric callendar. | |
Secondary | Mother's psychological state regarding pregnancy | Assessed by Prenatal Evaluation Questionnaire (Armengol Asenjo et al., 2007), composed by 42 items divided in 7 dimensions: (1) pregnancy acceptance, (2) identification of the maternal role, (3) quality of the relationship with her mother, (4) quality of the relationship with her partner, (5) preparation for labour, (6) fear to pain and loss of control during labour, and (7) preoccupation for her and her baby's wellbeing. Possible answers are: A=a lot, B= with frequency, C= sometimes, and D= never (Likert scale, from 1 to 4 points). | Baseline | |
Secondary | Maternal anxiety | Assessed by State-Trait Anxiety Inventory (STAI) questionnaire (Jover et al., 2014). It is composed by 20 items and answers are given on a 4-point Likert scale (0= absolutely not and 4= very much). A high score indicates a higher anxiety. | Baseline, 8th-9th month of pregnancy, 4th month after delivery, 6th month after delivery | |
Secondary | Level of depression | Assessed by the Edinburgh Postnatal Depression Scale (EDPS) (Garcia-Esteve et al., 2003). This questionnaire composed by 10 items (answered punctuated 0-3 depending on symptoms severity) will show us the level of depressive symptoms participants present. | Baseline, 8th-9th month of pregnancy, 4th month after delivery, 6th month after delivery | |
Secondary | Breastfeeding efficacy and certainty | Assessed by the Breastfeeding Self-Efficacy Scale (Oliver-Roig et al., 2012). Punctuation is set in a 5-point Likert-type scale where 1 indicates not at all confident and 5 indicates always confident. The higher the score, the higher level of breast- feeding self-efficacy. | Week 2 after delivery, 4th month after delivery | |
Secondary | Parental feeding styles | Assessed by the Parental Feeding Styles questionnaire (Wardle et al., 2002). 27 items are divided in four subscales: emotional feeding, instrumental feeding, encouragement to eat new foods, and control over eating. Answer range goes from 1= never to 5= always. A high score in each subscale means a higher level on that issue. | 6th month after delivery, 12th month after delivery, 18th month after delivery | |
Secondary | Acceptance of novel foods (1) | Assessed by an ad hoc questionnaire. | 6th month after delivery, 12th month after delivery, 18th month after delivery | |
Secondary | Acceptance of novel foods (2) | Assessed by videotaped meals. The Feeding Infants: Behaviour and Facial Expression Coding System (FIBFECS) (Hetherington et al., 2016) will be taken into consideration for this issue. | 6th month after delivery, 12th month after delivery, 18th month after delivery |
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