Bimbingamba Zerosix Third Phase: Studying Communities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Rate of weigh/overweight subjects
研究概览
简要总结
Childhood obesity is increasing in the last years especially in developed countries, and, as well as adult obesity, is related to the development of pathologies. Unfortunately, the restoration of a normal weight condition, if the ponderal excess rose in the first years of life, seems very difficult. Despite the importance of this issue, there is a paucity of evidence demonstrating effective interventions in reducing weight over time. The observation that in developed countries childhood obesity appears with evident social and geographical gradients justifies the implementation of inter-sectoral interventions of primary prevention, to be declined at the contextual level: family and community. Nowadays, there are numerous interventions for the promotion of lifestyle in pediatric age, in particular, those aimed at primary school and adolescence. On the other hand, few interventions were directed at the 0-7 age group.
Therefore, this community intervention trial involved the pediatric population (aged 0-7 years) and their families, and it is aimed at the prevention of obesity and the restoring normal weight through community interventions aimed at improving lifestyles and with them the bio-metric parameters, health and well-being outcomes and soft skills in the population aged 0-7 years.
The target population is children aged 0-7 years resident in the two municipalities (Mondovì and Savigliano), respectively selected as Intervention and Control Common. Totally, to conduct this study 2000 children, of both sex, will be enrolled (near 1000 for each of the two Municipalities).
详细描述
Bimbingamba is an initiative promoted by "Fondazione Compagnia di San Paolo" with the aim of achieving healthy nutrition and physical exercise among children, aged 0-7 years. The initiative will take place in Mondovì (Cuneo, Italy), selected as the intervention Municipality, and will involve resident children with their families. Due to the common interest in the topic, Compagnia di San Paolo has requested the University of Eastern Piedmont of collaborating on the project.
As reported by literature, childhood obesity presents a multifactorial origin being determined by the interaction between environmental and genetic factors. Increased habits in consuming "junk foods", sweetened beverages, unhealthy lifestyles, and low levels of physical activity are the major driving factors for the development of obesity during childhood. The restoration of a normal weight condition, especially if the ponderal excess rose in the first years of life, seems very difficult to achieve not only because of behavioral mechanisms but also of epigenetic imprinting. The interest of this study is the prevention of the obese phenotype in children together with the restoration of normal weight. There are a great number of interventions centered on the promotion of a healthy lifestyle in adolescents, but few of these are focused on infancy, especially interventions directed to the 0-7 age group. According to reported knowledge, preventing obesity in childhood is important for reducing the risk of obesity among adolescents and adults. Therefore preventing/reducing the related comorbidities.
This intervention study will be conducted in two Italian Commons, Mondovì and Savigliano, respectively selected as the interventional Municipality and control Municipality. The study will include at least 200 children between 0-7 years with their families living and residing in one of the two cities. The main objectives of this study will be the description of weight status during the time in the 0-7 aged group in relation to the socio-economic factors, parental parameters, families, and lifestyle habits. As a secondary objective, this study aims to evaluate the effectiveness of interdisciplinary interventions in the community. Therefore, evaluating lifestyle promotion, health improvement, and soft skills acquisition in the 0-7 aged group.
Interventions will be administered during organized events involving the participation of children and their families together with the presence of specialized staff (nutritionists, personal trainers, educators). During these days children will be educated in the Mediterranean diet and healthy cooking (preparing simple meals with their parents) guided by nutritionists and will be involved in recreational and motor activities to promote physical activity.
Participants' recruiting will occur during the organized events, in places of birth, kindergarten, and vaccination centers through informative materials. On the occasion of the first meeting, those parents apparently interested will be given the materials and the link for the application (https://bimbingambazerosei.app.interacta.space/) through which join the projects and fill out the informed consent for them and their children. Recruiting period will start in April 2023.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Days 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 0-5 year of both sex resident in the two Municipalities under evaluation
- •children having date of birth between 1/1/2018 and 31/12/2022 (subjects born 5 years prior to the start of the project)
- •newborns between 01/1/2023 and 21/6/2023 residing in the two municipalities under study.
排除标准
- •Residence/domicile in the municipalities under investigation, for a period of time less than 6 months following recruitment;
- •Recruitment of the child in other intervention trials of any nature.
结局指标
主要结局
Rate of weigh/overweight subjects
时间窗: Change in body weight at time 0 and 24 months.
Variation in total body weight in children belonging to the intervention or control groups at times 0 and 24 months.
Rate of Mediterranean Diet (MD) adherence
时间窗: Change in KIDMED score at time 0 and 24 months.
Variation in nutritional habits (Western Diet to Mediterranean Diet) in both control and intervention groups at times 0 and 24 months. Habits in consuming MD are evaluated with KIDMED (Mediterranean Diet Quality Index) questionnaire, the scores are as follows: total score = 12 points lower than 3 = low adherence to MD between 4-7= moderate adherence to MD higher than 8= high adherence to MD
Nutritional habits
时间窗: Changes in nutritional habits between time 0 and 24 months
Nutritional habits will be evaluated in both the control and intervention groups through the use of the Andromeda questionnaire. This questionnaire will be performed at time 0 (during the enrollment) and 24 months later. Andromeda is a questionnaire that collects information on eating habits in terms of the frequency of food consumption in the last year. Therefore, the questionnaire assesses dietary habits before the start of the observation period (t0) and 24 months (two years) after the observation or intervention period. There is no score for this questionnaire, it divides food into macro-categories giving information about the nutrients assumption.
Physical activity level
时间窗: Change in IPAQ score at time 0 and 24 months.
Variation in physical activity level assessed by the International Physical Activity Questionnaire "IPAQ" in both control and intervention groups at time t0 and 24 months. IPAQ scale is based on MET (minutes of physical activity per week): lower than 30 minutes per day = low level of physical activity equal to 30 minutes per day= moderate level of physical activity higher than 3000 minutes per week (MET)= high level of physical activity
Adherence to Mediterranean Diet
时间窗: Changes in the adherence of Mediterranean Diet between 0 and 24 months.
Evaluate the Mediterranean Diet adherence (consumption of fruit, vegetables, nuts, extra virgin olive "EVO" oil, and so on) before and after the intervention in both control and intervention groups. The questionnaire will be performed on time t0 (time of enrollment) and time t24 (24 months later). This questionnaire gives as results the percentage of macronutrient and micronutrient consumption and the association with Mediterranean Diet adherence.
Access rate to Emergency Room (ER) and Pediatricians of Free Choice (PFC)
时间窗: Changes in the ER and PFC accesses at time 0 and 24 months.
Comparison in number of times visiting ER and PFC among the intervention and control group at times 0 and 24 months.
Change in physiological parameters
时间窗: Variation in Likert scale points at time 0 and 24 months.
Variation in self-confidence, self-control, and socialization level in control and intervention groups at times 0 and 24 months. These physiological parameters are evaluated through the use of Likert scale having 5 points: 1. Very satisfied. 2. Moderately satisfied. 3. Neither satisfied nor dissatisfied. 4. Moderately dissatisfied. 5. Very dissatisfied
次要结局
未报告次要终点
研究者
Flavia Prodam
Associated Prof. in Clinical Nutrition and MD
Azienda Ospedaliero Universitaria Maggiore della Carita