Institute of Mother and Child
Warsaw, 01-211, Poland
NCT Number: NCT07357857
The goal of this interventional study is to assess the effectiveness of the school-based "High Five!" program in reducing overweight, obesity and high blood pressure in children aged 7-9 years old. The main questions it aims to answer are:
* Does participation in the "High Five!" program reduce the proportion of child participants with elevated body mass index (BMI), waist and hip circumference, and blood pressure? * Does participation in the "High Five!" program increase adherence to recommended health behaviors (healthy eating, physical activity, screen time management, and sleep hygiene) among participating children? Researchers compare "High Five!" to the school practice as usual to see if this program works to prevent overweight and related health problems in children.
Students participate in 6 sessions. Sessions 1-5 are dedicated to five health-related topics such as mental health, nutrition, physical activity, screen time and sleep while session 6 serves as a summarizing and reinforcing lesson. Sessions are based on active methods (play, individual / small group work) and carried out in accordance with detailed scenarios by trained specialists: the class teacher and the school nurse.
Parents/guardians of participating students are engaged in promoting healthy behaviors and creating a supportive home environment via self-reading of the "portions of knowledge" on the topics covered by the program and completion of home tasks with their children.
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Notify Me6 year–9 year
All sexes
Interventional
Not applicable
Warsaw, 01-211, Poland
Background:
Excessive body weight in children is a serious and increasing health problem associated with: elevated blood pressure, risk of obesity in adulthood, poor relationships with peers, negative perception by other (as of lower intelligence, lazy etc.), susceptibility to bullying, low self-esteem and a critical attitude towards oneself.
The key risk factors of overweight in children include: low physical activity, sedentary behaviours, unbalanced diet (too much sugar-sweetened beverages and fast food), sleep disorders and mental health problems.
There are many interventions aimed at reducing overweight and obesity among children, especially those implemented in school settings. However, there is no clear evidence regarding their long-term effectiveness on obesity-related outcomes.
Objectives:
The goal of this clinical trial is to assess the effectiveness of the school-based "High Five!" program in reducing overweight, obesity and high blood pressure in children aged 6-9 years old. The main questions it aims to answer are:
Intervention:
The High Five! Program is based on the Life course theory claiming that people pass through a sequence of age-based stages and social roles within particular social structures over their lifetime that affects their health, including their body mass. The process of acquiring the skills necessary for living and acting in society to achieve life goals is extremely intensive at the beginning of school, influenced by the social environment. Children learn what behaviors are expected of them and whether they do what they do correctly. Skills acquired at this age and in this environment (classroom) help them cope with new circumstances in the future, thus becoming a lifelong asset. In this context, involving parents in the intervention via assignments, meetings, informative material and encouraging them to improve the home environment is one of the key determinants of the effectiveness of the intervention. In accordance with the family-individual-school (FIS) model of comprehensive childhood obesity prevention, "students connect the family and school, whereas parents collaborate with the school to contribute to the intervention program".
The High Five! Program is adapted to the developmental age of the 7-9 years old participants for whom, play is the favorite form of activity. Children of this age are entering a period of developing perseverance and diligence. Thay want to learn more than ever in their later lives. Therefore, it is extremely important to maintain their enthusiasm and create conditions at school that promote well-being and success. The greatest threat during this period is the child developing a belief in their own low self-worth. Children at this age enjoy listening to and telling stories, which they also use in play. They also enjoy making their own toys. They have good memory skills, especially rhymes and songs. Repetition of the same information promotes memorization. This period is also characterized by the ease of acquiring new motor skills and their improvement. This has a positive impact on daily activities, exercise, participation in sports, crafts, and playing musical instruments. And schoolteachers trained to implement health promoting interventions can have a significant impact on students' dietary behaviors.
The High Five! Program aims to prevent overweight, obesity and high blood pressure in children, by:
The High Five! Program activities include:
Sessions are based on active methods (play, individual / small group work) and carried out in accordance with detailed scenarios by trained specialists: the class teacher and the school nurse.
Study design Researchers compare "High Five!" to the school practice as usual to see if this program works to prevent overweight and related health problems in children. The cluster randomized control trial (cRCT) design with a 1:1 ratio (experimental group vs. control group) is applied. The sampling unit is the school, and the sampling is stratified based on the size of the locality (rural/small town/large city). In each school, first- and/or second-grade classes are selected to participate. The characteristics of school environment in terms of systemic/organizational solutions at school that promote healthy eating, physical activity and a social climate friendly to students and parents will be taken into account in the outcome analysis.
Data collection is conducted in four phases: baseline (shortly before the first program session), mid-intervention (in average - after two weeks , post-intervention (shortly after the last program session), and 6-month follow-up. The evaluation includes standardized anthropometric measurements and questionnaires. Children are assessed by school nurses four times, using the Child Examination Report (height, weight, waist/hip circumference, blood pressure). Parents complete a questionnaire evaluating their child's health behaviors (e.g. diet, physical activity, screen time, sleep), emotional well-being (PSC-17), and their own health-related knowledge and supportive parenting practices 3 times (at the baseline, post-intervention and at the follow-up). Students evaluate their own health-related behaviors by marking on the picture scale, for how many days in the last 7 days, they did each of them. They answer the same question four times (at the baseline, mid-intervention, post-intervention, and 6-month follow-up). School staff (e.g., principals) will complete a questionnaire assessing the school's capacity to promote healthy behaviors. This includes food and beverage availability, opportunities for physical activity, school health policies, and implementation of health promotion initiatives.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Primary schools (public, private, general, inclusive) being a student at a school/class taking part in the study
Exclusion criteria
Special schools lack of parental consent for the child to participate in the program lack of child's oral consent to participat
The "High Five!"program is based on the Life course theory and family-individual-school (FIS) model. Students are the main target groups of the program, and parents cooperate with the school to enhance the effects of the intervention.
Activities addressed to students include the implementation of 6 scenarios, concerning health-related issues, carried out in accordance with detailed scenarios by trained teacher and school nurse. Parents support th program by performing special home tasks together with the child.
Time frame: From enrollment to the end of the follow-up at 6 month
Time frame: From enrollment to the end of the follow-up at 6 month
Time frame: From enrollment to the end of the follow-up at 6 month
Time frame: From enrollment to the end of the follow-up at 6 month
Emotional and behavioral problems in children are assessed by 17-items version of The Pediatric Symptom Checklist (PSC-17) for parents. The total and the subscale scores will be analysed and the following cutoffs will be taken as indicators of the:
PSC-17 - Inetrnalized problems ≥ 5 PSC-17 - Attention deficites ≥ 7 PSC-17 - Externalized problems ≥7 Total Score ≥ 15
Time frame: From enrollment to the end of the follow-up at 6 month
The Parental Support and Control 20-items scale was developed specifically for this study. It consists of 20 statements describing parental behaviors that express emotional support for the child (10 statements, e.g. "I hug and cuddle my child") and control of the child (10 statements, e.g. "I know my child's friends"). For each statement, respondents select one of the following answers: 0 - "Rarely"; 1 - "Sometimes"; 2 - "Often". The higher the score, the stronger the support and control of the child by the parents.
Both the subscale scores and the overall score will be analyzed. Since the scale was previously only pilot tested in a small group, the analysis of its psychometric properties will precede the analysis of the program results.
Time frame: From enrollment to the end of the follow-up at 6 months
The assessment is based on parents' answer to the single question on the numer of days per week the child meets the WHO recommendation for daily MVPA (Moderate-to-Vigorous Physical Activity) - being active for at least 60 minutes.
Time frame: From enrollment to the end of the follow-up at 6 months
Assessment based on parental responses to the question, "In a typical week (including weekends), how much time does your child spend on average playing sports/exercise/dance classes at a sports club/health club/fitness center/dance academy? (By sports and exercise, we mean soccer, playing on the field, hockey, swimming, tennis, basketball, gymnastics, ballet, fitness classes, dance classes, etc.)." 5-point response scale: Not at all; 1-2 hours per week; 3-4 hours per week; At least 5 hours per week; I don't know
Time frame: From enrollment to the end of the follow-up at 6 months
Assessment based on parental responses to the question "Does your child participate in sports club activities?" 4-point response scale: Yes, regularly and actively; Yes, occasionally; Not currently, but has participated in the past; No and has never participated
Time frame: From enrollment to the end of the follow-up at 6 months
The child's sleep time is assessed by parents who indicate the time a child usually falls asleep (hours and minutes) and the time child usually wakes-up (hours and minutes).
Time frame: From enrollment to the end of the follow-up at 6 months
Parents answer the question: "In a typical week, how often does your child eat breakfast (something more than just a drink, e.g., milk, tea, juice), including breakfast at school? Please select one answer. Never; A few days (1-3 days); Most days (4-6 days); Every day
Time frame: From enrollment to the end of the follow-up at 6 months
Parents answer the question: "In a typical week, how many servings of fresh fruit and/or vegetables does your child eat per day? (One serving is the amount your child can fit in the palm of their hand, e.g., 4 dessert spoons of cooked vegetables, a small bowl of salad, a small bowl of vegetable soup; 1 medium-sized fruit [1 small apple], 2 small fruits [2 plums], 4-7 strawberries, or 10-14 cherries.)" choosing one of the categories: Not at all; Less than 1 serving per day; 1-2 servings per day; 3-4 servings per day; 5 or more servings per day
Time frame: From enrollment to the end of the follow-up at 6 months
The index of rules for good sleep for children is composed of five questions answered by parents and covers: bathing/showering, brushing teeth, airing the room, relaxation (listening to a bedtime story, talking with a parent, etc.) before bad and not watching TV or using a cell phone for at least half an hour before bed. For each question, parents can choose one of three answers: (Usually (5-7 days a week); Sometimes (2-4 days a week); Rarely (1-2 days a week)) and the indicator of regular use of a given practice is the answer "Usually (5-7 days a week)"
Time frame: From enrollment to the end of the follow-up at 6 months
Parents indicated how often, considering a typical week, their child consumes fresh fruit (excluding fruit juices and dried fruit) choosing one out of six response categories ranging from Never to More than once a day. Responses ranging from Once a day to More than once a day indicate regular consumption.
Time frame: From enrollment to the end of the follow-up at 6 months
Parents indicated how often, considering a typical week, their child consumes vegetables (including vegetable soups, excluding potatoes) choosing one out of six response categories ranging from Never to More than once a day. Responses ranging from Once a day to More than once a day indicate regular consumption.
Time frame: From enrollment to the end of the follow-up at 6 months
Parents indicated how often, considering a typical week, their child consumes sugar-containing beverages choosing one out of six response categories ranging from Never to More than once a day. Responses ranging from 4 to 6 - more than 3 days per week indicate frequent consumption.
Time frame: From enrollment to the end of the follow-up at 6 months
Parents indicated how often, considering a typical week, their child consumes salty snacks (e.g. potato chips, corn chips, popcorn, peanuts) choosing one out of six response categories ranging from Never to More than once a day. Responses ranging from 4 to 6 - more than 3 days per week indicate frequent consumption.
Time frame: From enrollment to the end of the follow-up at 6 months
Parents indicated how often, considering a typical week, their child consumes sweet snacks (e.g. cakes, cookies/biscuits, sweet desserts) choosing one out of six response categories ranging from Never to More than once a day. Responses ranging from 4 to 6 - more than 3 days per week indicate frequent consumption.
Time frame: From enrollment to the end of the follow-up at 6 months
Parents indicated how often, considering a typical week, their child consumes fast food products (e.g. pizza, casserole, hamburger) choosing one out of six response categories ranging from Never to More than once a day. Responses ranging from 4 to 6 - more than 3 days per week indicate frequent consumption.
Time frame: From enrollment to the end of the follow-up at 6 months
Parents indicate how often, on a typical week, they eat breakfast with a child by choosing one of the answers: Never, Less than once a week, 1-2 days a week, 3-4 days a week, 5-6 days a week, Every day. Two last categories indicate regular behavior.
Time frame: From enrollment to the end of the follow-up at 6 months
Parents indicate how often, on a typical week, they eat lunch with a child by choosing one of the answers: Never, Less than once a week, 1-2 days a week, 3-4 days a week, 5-6 days a week, Every day. Two last categories indicate regular behavior.
Time frame: From enrollment to the end of the follow-up at 6 months
Parents indicate how often, on a typical week, they eat diner with a child by choosing one of the answers: Never, Less than once a week, 1-2 days a week, 3-4 days a week, 5-6 days a week, Every day. Two last categories indicate regular behavior.
Time frame: From enrollment to the end of the follow-up at 6 months
Parents answer the question "In their free time: how many hours a day does your child spend on playing games on a computer, console, tablet, smartphone, TV" by selecting one of 9 answers (from Not at all to About 7 or more hours a day)
Time frame: From enrollment to the end of the follow-up at 6 months
Parents answer the question "In their free time: how many hours a day does your child spend using a computer or other electronic devices for academic activities, including homework" by selecting one of 9 answers (from Not at all to About 7 or more hours a day)
Time frame: From enrollment to the end of the follow-up at 6 months
Parents answer the question "In their free time: how many hours a day does your child spend watching TV, movies or videos on sites like YouTube, etc." by selecting one of 9 answers (from Not at all to About 7 or more hours a day)
Time frame: From enrollment to the end of the follow-up at 6 months
Parents answer the question "In their free time: how many hours a day does your child spend searching for information on the Internet, browsing websites." by selecting one of 9 answers (from Not at all to About 7 or more hours a day)
Time frame: From enrollment to the end of the follow-up at 6 months
Parents answer the question "In their free time: how many hours a day does your child spend on other sedentary activities, e.g. reading books, playing an instrument." by selecting one of 9 answers (from Not at all to About 7 or more hours a day)
Time frame: From enrollment to the end of the follow-up at 6 months
Students mark on the picture scale answer to the question "How many days in the last week (last 7 days) did you eat vegetables - fresh (e.g., carrots) or cooked (e.g., broccoli, potatoes)?". They select one out of five answers: never, 1 day, 2-3 days, 4-5 days, 6-7 days
Time frame: From enrollment to the end of the follow-up at 6 months
Students mark on the picture scale answer to the question: "How many days in the last week (last 7 days) did you eat fruit - for example, an apple, a banana or a pear?". They select one out of five answers: never, 1 day, 2-3 days, 4-5 days, 6-7 days
Time frame: From enrollment to the end of the follow-up at 6 months
Students mark on the picture scale answer to the question: "How many days in the last week (last 7 days) did I walk, ride a bike, ride a scooter to (or from) school?". They select one out of five answers: never, 1 day, 2-3 days, 4-5 days, 6-7 days
Time frame: From enrollment to the end of the follow-up at 6 months
Students mark on the picture scale answer to the question: "How many days in the last week (last 7 days) you were active - you moved a lot, ran, danced, played football or swam?" They select one out of five answers: never, 1 day, 2-3 days, 4-5 days, 6-7 days
Time frame: From enrollment to the end of the follow-up at 6 months
Students mark on the picture scale answer to the question: "How many days in the last week (last 7 days) you slept for 9 hours or more last night?" They select one out of five answers: never, 1 day, 2-3 days, 4-5 days, 6-7 days
Time frame: From enrollment to the end of the follow-up at 6 months
Students mark on the picture scale answer to the question: "How many days in the last week (last 7 days) before going to bed, you listened to calming music, a story, or read something interesting?" They select one out of five answers: never, 1 day, 2-3 days, 4-5 days, 6-7 days
Time frame: From enrollment to the end of the follow-up at 6 months
Students mark on the picture scale answer to the question: "How many days in the last week (last 7 days) did you spent less than 2 hours in front of the computer, phone, or tablet?" They select one out of five answers: never, 1 day, 2-3 days, 4-5 days, 6-7 days
Time frame: From enrollment to the end of the follow-up at 6 months
Students mark on the picture scale answer to the question: "How many days in the last week (last 7 days) you did not use the phone, computer, or tablet right before going to bed?" They select one out of five answers: never, 1 day, 2-3 days, 4-5 days, 6-7 days
Time frame: From enrollment to the end of the follow-up at 6 months
Students mark on the picture scale answer to the question: "How many days in the last week (last 7 days) after school you played with other children, e.g., in the yard or on the playground?" They select one out of five answers: never, 1 day, 2-3 days, 4-5 days, 6-7 days
Time frame: From enrollment to the end of the follow-up at 6 months
Students mark on the picture scale answer to the question: "How many days in the last week (last 7 days) did you spent free time with your loved ones - you played together, talked, or did something else?" They select one out of five answers: never, 1 day, 2-3 days, 4-5 days, 6-7 days
Institute of Mother and Child, Warsaw, Poland
Other
Effectiveness of the "High Five!" Program for Reducing the Risk of Overweight and Obesity in Early School-age Children
Acronym: DINO-PL
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