ECR Visant à évaluer l'Effet d'Une Intervention Sur la Diffusion d'Informations (Conduite de la Diversification Alimentaire) Sur le Comportement de Nourrissage Des Parents, le Comportement Alimentaire et le Statut pondéral de l'Enfant
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Body mass index z-score at the age of 36 months
研究概览
简要总结
The purpose of this randomized controlled trial is to conduct an intervention aimed at providing first-time parents with information on the conduct of complementary feeding through a paper brochure and a smartphone application, to test the effect of this intervention (compared to usual care, i.e. receiving the paper brochure only), on infant corpulence at 36 and 48 months of age, and parental feeding practices and infant eating behavior up to 36 months of age.
详细描述
The intervention will consist in the dissemination of new French recommendations relating to complementary feeding, in particular in connection with an educational device in the form of a smartphone application delivering relevant infant feeding messages in due time between the ages of 3 and 36 months.
In France, new recommendations relating to complementary feeding are disseminated to the general public by Santé publique France (the French Public Health Agency) since September 2021 in the form of a paper brochure. Based on the recommendations of this brochure, a smartphone application was developped.
Parents in the intervention (n=165) and control groups (n=165) will receive the paper brochure when the infant will reach the age of 3 months. In the intervention group, a smartphone application will additionnaly support this paper medium, providing information and very short videos illustrating some aspects of responsive feeding during complementary feeding and taking up the themes of the paper brochure. Information will be sent through the smartphone app regularly until the children reach the age of 36 months. In total 106 specific messages will be sent to parents between 3 and 36 months in the intervention group and 48 generic messages to both groups.
The main objective is to determine if the intervention is associated to a difference between the BMI z-score at the age of 36 months of the children of the parents of the intervention group, compared with those of the control group. Parental feeding practices and infant eating behavior will be evaluated several times during the follow-up from the 3rd month of the infant until his 48th month with various validated questionnaires from the literature (n=330) and with behavioral evaluations (n=130, 65 in each group) carried out during meals filmed in the laboratory and at the participants' homes.
Our goal is to involve a total of 330 parents and children (with only first-time parents); the first 30 children will allow us to test the device but their data may not be included in the final analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Parents are informed that the aim of the study concerns the effect of the dissemination of information relating to the conduct of complementary feeding on parental feeding behavior during meals as well as on the eating behavior of their child, but they are blinded to the group (intervention vs. control) to which they are allocated.
Parents are randomized into 2 groups (intervention vs. control) via the smartphone application. The investigators conduct the study without information on group allocation. The investigators will analyse the data without information on group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •first-time parents
- •child age is between 1 and 54 days
- •parents living in Dijon and its surroundings (~ 70 km around Dijon)
- •parents who master enough the french language to understand and answer self-reported questionnaires
排除标准
- •no affiliation to a social security scheme
- •parents of a child born before 31 weeks of amenorrhea
- •parents of a child presenting since birth with pathologies likely to have a strong impact on his diet or his feeding habits (allergy to cow's milk proteins, feeding through a nasogastric tube or gastrostomy, congenital defect of the digestive tract, oral feeding disorders)
- •parents of a child with a multiple pregnancy (≥ 3 children).
- •in the event of a twin birth, the follow-up for this study only focuses on one of the children (according to a random draw)
- •additional exclusion criteria for participation in filmed meals from the age of 11 months: children with food allergies or intolerances or suffering from celiac disease.
研究组 & 干预措施
paper brochure + smartphone application
Parents will receive the paper brochure (new communication support developed by Santé publique France (the French Public Health Agency)), which is the current official information on complementary feeding (CF) in France. They will also receive the new recommendations relating to complementary feeding through an educational device in the form of a smartphone application. This app will deliver information and very short videos illustrating various aspects of responsive feeding during CF and taking up the themes of the paper brochure. These 106 messages will be delivered regularly from the 3rd month until the 36th month of the child. Parents will also receive generic information (48 messages) contained in the health record and in connection with the general development.
干预措施: Provision of extended information on the conduct of complementary feeding (Behavioral)
paper brochure
Parents will receive the paper brochure (new communication support developed by Santé publique France (the French Public Health Agency)), which is the current official information on complementary feeding (CF) in France. Parents will also receive generic information (48 messages) contained in the health record and in connection with the general development.
干预措施: Provision of current official information on complementary feeding (Behavioral)
结局指标
主要结局
Body mass index z-score at the age of 36 months
时间窗: End of intervention (at the age of 36 months)
Z-score of the body mass index (BMI, kg / m²) at the age of 36 months of the child of the parents included in the study, calculated from measurements of the child's weight and height at the age of 36 months (carried out in the laboratory) and according to the WHO references.
次要结局
- Body mass index z-score at the age of 48 months(Follow-up (at the age of 48 months))
- Infant appetite control abilities (behavioral observation)(at the age of 30 months)
- Maternal distractions during feeding - Perceived Distraction(at the ages of 12, 24, 36 months)
- Children's eating behaviour (self-reported by parents)(at the ages of 12 and 36 months)
- Child feeding skills(at the ages of 12 and 36 months)
- Meal context - FFBS(at the ages of 12, 24, 36 months)
- Maternal distractions during feeding - Use of technological distractors(at the ages of 12, 24, 36 months)
- Infant appetite control abilities (self-reported by parents)(at the ages of 12 and 36 months)
- Parental feeding practices (self-reported by parents)(at the ages of 12, 24, 36 months)
- Introduction of complementary foods(at the ages of 3, 6, 12, 18, 24, 36, 48 months)
- Food texture exposure and acceptance(at the age of 12 months)
- Food frequency and food acceptance(at the age of 36 months)
- Meal context - FPSQ(at the ages of 12, 24, 36 months)
- Knowledge about infant nutrition(at the age of 36 months)
- Parental feeding practices (behavioral observation)(at the ages of 32 and 36 months)