Changes in the Dietary Patterns of Adults in Family Units With a Newly Diagnosed Type 1 Diabetes Mellitus Child: Impact of Educational Actions Derived From Standard Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Food frequency estimation
研究概览
简要总结
The goal of this observational study is to compare the feeding pattern evolution in parents whose children have been newly diagnosed with type 1 diabetes mellitus, versus one year later. The main question it aims to answer is:
- Does the dietary intervention in the pediatric population affect the parent's diet?
详细描述
Parents with newly diagnosed type 1 diabetes infant will be identified upon hospital admission.
Parents will be informed about the study and asked if they are willing to participate. If affirmative, the participant parent will sign the informed consent, and one of the investigators will hand over the different questionnaires. A brief physical exploration will be performed.
After one year, and coinciding with any programmed visit to the hospital, questionnaires will be handed over again, together with the repetition of the brief physical exploration.
The questonnairs include: Food register, Mediterranean adherence, physical activity, pediatric anxiety, and hospital anxiety and depression scale questionnaires.
Data will be extracted from the questionnaires, and analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old
- •Parents or legal tutors of a child with type 1 diabetes (according to ADA criteria).
- •Less than 1 week since the type 1 diabetes diagnostic.
- •Living together more than 40%of the time with the infant with type 1 diabetes.
- •Be the adult responsible for most of the family meals.
排除标准
- •Parents of infants with other types of diabetes (type 2, MODY, gestational, others).
- •Household members with diseases or conditions that can affect dietary habits (type 2 diabetes, kidney disease, pregnancies).
- •Significant dietary habit modifications (change to a vegeterian, vegan, palea, or other diets, fasting situations) in the last month prior to the diagnosis of type 1 diabetes.
结局指标
主要结局
Food frequency estimation
时间窗: 1 year
Food and beverage consumption are evaluated with the deliverance of a Food Frequency Questionnaire tool - the Cuestionario de Frecuencia de Consumo de Alimentos (CFCA) - with 137 items and validated for the spanish population. A copy of the CFCA in english is attached in the protocol. Changes in portions, food items, and frequency can be estimated through the comparison of the questionnaire at basal and half time. The questionnaire evaluated will be the ones handled at the start and at the end of the study (0 and 12 months).
Adherence to Mediterranean Diet (Predimed questionnaire)
时间窗: 1 year
Predimed questionnaire, with 14 items and a punctuation associated to each answer answer, allowes the obtantion of a score. Obtaining a score of less than 9 indicates a poor adherence to the mediterranean diet, and obtaining a score of 9 or more indicates a good adherence to the mediterranean diet. English version: http://www.predimed.es/uploads/8/0/5/1/8051451/p14\_meddiet\_english\_version.png The questionnaire evaluated will be the ones handled at the start and at the end of the study (0 and 12 months).
次要结局
- Food frequency estimation (half time)(6 months)
- Adherence to Mediterranean Diet (predimed) (half time)(6 months)
- Physical activity characterization(6 and 12 months)
- Emotional stress characterization(6 and 12 months)
- Emotional impact of the diagnosis characterization(6 and 12 months)
研究者
Joana Rossell
postdoctoral researcher
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau