Adult Fathers and MothersNCT06248164
Relationship of Lifestyle Habits and Health Characteristics of Parents and Children
An observational study of Adult Fathers and Mothers and Children and Adolescents, Boys and Girls, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
Lifestyle habits and health characteristics (e.g., excess weight) acquired in childhood and adolescence have a good chance of being carried into adulthood. In this sense, seeking to understand which factors can influence these habits and/or characteristics is of paramount importance. Read more about this study
- Who is it for?
- Ages 6 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Fathers and Mothers, Children and Adolescents, Boys and Girls
- How many people
- 176 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 89 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The project will be carried out with children and adolescents from six years of age. The project will be publicized through social media, such as Facebook, WhatsApp, Instagram and also through television and radio. Participants who are interested in participating in the project and appear at the FCT-UNESP premises; parents must sign the informed consent form authorizing their children to participate in the study, as well as parents must also sign the consent form also agreeing to participate in the study (since this project will evaluate the health parameters of parents and children). Furthermore, children and adolescents must sign a consent form agreeing to participate in the study.
Who may be able to join
- Children and adolescent over 6 years old.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Diego Giulliano Destro Christofaro
Presidente Prudente, São Paulo, 19060-900
Diego GD Christofaro, PhD, +551832295713, ddcleite@yahoo.com.br
About this study
Official title: Relationship of Lifestyle Habits and Health Characteristics of Parents and Children: An Epidemiological Study
Lifestyle habits and health characteristics (e.g., excess weight) acquired in childhood and adolescence have a good chance of being carried into adulthood. In this sense, seeking to understand which factors can influence these habits and/or characteristics is of paramount importance. One of these factors that can influence the health of children and adolescents are the lifestyle habits and characteristics of these young people's parents. One of the lifestyle habits that appears to be related between parents and children is physical activity. However, most studies analyze the practice of physical activity between parents and children only considering the practice of total physical activity, that is, not considering the different domains of physical activity [ i) physical efforts carried out in the work environment, occupations in the case of adults and in the school environment in the case of children and adolescents; ii) physical activities carried out during leisure time; iii) physical activities carried out in the form of active commuting], in addition to there being little information considering the different intensities of physical activity (light, moderate, vigorous and very vigorous). Another gap to be addressed is the relationship between other health variables between parents and children, including unhealthy lifestyle habits, such as smoking, eating disorders and symptoms of anxiety and depression, as well as adverse health conditions, such as the presence of chronic diseases. and overweight, would be different considering the parents' practice of physical activity, for example; whether the possible relationship between excess weight between parents and children would be similar in children of physically active parents when compared to children of insufficiently active parents. Therefore, the objective of the present study will be to verify whether the different domains and intensities of physical activity are related between parents and children, as well as to verify whether other lifestyle habits and health characteristics are related between parents and children, considering the levels of activity. physical status of parents (physically active and insufficiently active).
- Being tested
- No intervention
- Keywords
- Family atmosphere, Lifestyle, Public health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
We will not carry out any type of intervention, just observe the behaviors and health parameters of parents and children.
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescents (sons and daughters) | The study will consist of children and adolescents from six years of age. Receives: Other: No intervention | |
| Parents (mothers and fathers) | The study will consist of children and adolescents from six years of age and at least one of their biological parents to be evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective measure of physical activity
The objective measurement of physical activity will be performed using the Actigraph GT3X accelerometer (ActiGraph, LLC, Pensacola, FL, USA). Evaluated will remain with the equipment for five full days (three weekdays and two weekend days).
Measured: Baseline
Subjective measure of physical activity
Physical activity in different domains will be assessed using the questionnaire by Baecke et al. (1982). This instrument assesses the practice of physical activity through 16 questions in the last twelve months considering physical effort at work (for adults) and at school (for children and adolescents), the practice of sports activities or systematic exercises during leisure time and activities occupation in free time. In the field of work or school (in the case of children and adolescents), issues relating to physical efforts carried out at work are investigated, such as: time spent sitting, standing and walking in the work environment, carrying weights, whether the subject being assessed sweats a lot at work and how tired you feel after a day of work. In the leisure domain, leisure-time physical activity is considered, such as exercising at the gym or playing sports.
Measured: Baseline
Secondary outcomes (18)
Practice of physical activity in childhood and adolescence
To evaluate the practice of physical activity in childhood (ages 7 to 10 years) and adolescence (11-17 years) two questions will be asked: whether they practiced any type of sport in these stages of life under the supervision of a teacher, with two alternatives of answer: yes or no.
Measured: Baseline
Sedentary behavior (subjective measure)
To assess sedentary behavior, participants (parents and children) will answer the Sedentary Behavior Questionnaire (SBQ). It includes the domains of sedentary behavior (watching TV, playing video games and computer, sitting listening to music, sitting talking on the phone, working on the computer or bureaucratic tasks {e.g. answering emails}, playing a musical instrument, doing construction work art or crafts, sitting in a car, bus, or train) during the week and on weekends.
Measured: Baseline
Sedentary behavior (objective measure)
To assess CS with direct measurement, participants will use the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA). The accelerometer data will be filtered, digitized and adjusted to a frequency of 30Hz with an interval (epoch) of 60 seconds. The accelerometer will be analyzed by ActiLife 6 software (ActiGraph, LLC, Pensacola, FL, USA). Data will be considered complete if the participant wears the accelerometer for at least 10 hours per day for 4 days. It will be used to characterize sedentary behavior when measuring <100 counts/min (< 1.5 METs). The outcome of interest will be the time spent in sedentary activity, the number of minutes per day, which will be converted into hours for the analyses, according to the cutoff point of Matthews et al. (2008).
Measured: Baseline
Blood pressure
Blood pressure will be assessed using an Omron automatic blood pressure measuring device (Model HEM-742, Japan).
Measured: Baseline
Height
Height will be measured standing up, with a fixed stadiometer and with individuals barefoot, will be displayed in centimeters.
Measured: Baseline
Body mass
Body mass was measured using a digital scale, on which the individuals were barefoot and wearing light clothing, expressed in kilograms.
Measured: Baseline
Body mass index
Based on body mass and height measurements, the body mass index (BMI) will be calculated by dividing the participant's weight by their height squared, expressed in kilograms per meter squared.
Measured: Baseline
Waist circumference
Abdominal obesity will be determined by waist circumference, using an inextensible metallic tape, will be displayed in centimeters.
Measured: Baseline
Autonomic Cardiac Modulation
The heart rate variability will be collected by means of the POLAR V800
Measured: Baseline
Bone Mineral Density
The dual-energy X-ray absorptiometry technique (DEXA, Lunar DPX-NT; General Electric Healthcare, Little Chalfont, Buckinghamshire, United Kingdom) will be used to measure lean body mass in kilograms (kg) and bone mineral density (BMD ) in grams per square centimeter (g/cm2) of arms, legs, trunk, pelvis, spine and entire body. The equipment's own software will be used (GE Medical System Lunar, version 4.7). The analysis procedures were reported in a previous study by Saraiva et al. (2021). The machine's accuracy in terms of coefficient of variation was tested in a pilot study with 30 volunteers not involved in this study and resulted in an error of less than 1%. Both parents and children will undergo this assessment.
Measured: Baseline
Quality of life - Adults
To assess HRQoL, the Medical Outcomes Study SF-36-Item Short Form Health Survey (SF-36) instrument was used. The SF-36 is made up of 36 items that cover eight domains regarding HRQoL: functional capacity, physical limitations, body pain, general perception of health, vitality, social aspects, emotional limitations, mental health and current perception of health in comparison a year ago. This instrument presents a final score from 0 to 100, where 0 represents the worst score and 100 represents the best score in relation to HRQoL (WARE et al., 1992).
Measured: Baseline
Quality of life - Children and adolescents
Will be assessed using the KIDSCREEN-52 questionnaire. This instrument was developed in European countries to assess the health-related quality of life of children and adolescents (RAVENS-SIEBERER, et al., 2001). T
Measured: Baseline
Anxiety and depression
The Hospital Anxiety and Depression Scale (HADS) will be used, which contains 14 multiple-choice questions, seven of which assess symptoms of anxiety and seven of depression. Each item can be scored from 0 to 3 and the maximum score is 21, for both anxiety and depression (ZIGMOND \& SNAITH, 1983). This scale is also validated for use with children and young people (WHITE et al., 1999).
Measured: Baseline
Stress
This aspect will be assessed in the parents of adolescents participating in the study using the Brazilian version of the Perceived Stress Scale (COHEN et al., 1983), validated by Siqueira Reis et al. (2010) which consists of 14 items about the frequency of feelings and thoughts related to events and situations that occurred in the last month, with seven items being negative (1, 2, 3, 8, 11, 12 and 14) and seven items being positive (4, 5, 6, 7, 9, 10, and 13). Each item is answered on a five-point Likert frequency scale, with 0=never and 4=very often. The stress score is constructed by adding the values answered in each of the items, with positive items being on an inverse scale (0=very often and 4=never). The total score varies from 0 to 56 points and the higher the score, the higher the stress level.
Measured: Baseline
Musculoskeletal symptoms
The presence of musculoskeletal symptoms will be assessed using a questionnaire developed by Kuorinka et al. (1987) and validated for its use in the Brazilian population (PINHEIRO et al., 2002). This instrument assesses some musculoskeletal symptoms such as the presence of pain, tingling or numbness in different parts of the body (neck, shoulder, upper back, elbows, wrists/hands, lower back, hip/thigh, knees and ankles/feet ). It is noteworthy that this instrument is also validated for use with children and adolescents (LEGAULT et al., 2014). The intensity of pain and how long the participant has felt pain will also be assessed on a scale of zero to ten.
Measured: Baseline
Quality of sleep
Will be assessed using the Mini-sleep Questionnaire (ZOMER et al. 2005), validated for the Portuguese language (FALAVIGNA et al. 2011), which consists of 10 questions with seven possible answers. (never= 1, very rarely= 2, rarely= 3, sometimes= 4, often= 5, very often= 6 and always= 7) and provides a dimensionless score (higher score, worse sleep quality). The final score generated by the instrument can be classified as: good sleep (score between 10 and 24 points), slightly altered sleep (score between 25 and 27 points), moderately altered sleep (score between 28 and 30 points) and very altered sleep ( score above 30 points). Subjects who have a score equal to or greater than 28 points will be classified as having altered sleep.
Measured: Baseline
Sleep latency
Sleep latency will be investigated using the Pittsburg questionnaire (BUYSSE et al., 1989).
Measured: Baseline
Eating habits
Eating habits will be verified through the frequency of weekly consumption of different foods based on the work of Block et al. (2000). The consumption of foods such as vegetables, fruits, cereals, dairy products, fried foods, sodium and sugary drinks (soft drinks), as well as stimulant (energy) and caffeinated drinks will be analyzed.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Fathers and MothersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruna Thamyres Ciccotti Saraiva, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248164
- Sponsor's protocol ID
- 59261422.2.0000.5402
- Status last verified
- Mar 2025
- First submitted
- 27 Nov 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Lifestyle Habits and Health Characteristics of Parents and Children: An Epidemiological Study
- ClinicalTrials.gov ID
- NCT06248164
- Acronym / sponsor ID
- 59261422.2.0000.5402
- Keywords
- Family atmosphere, Lifestyle, Public health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lifestyle habits and health characteristics (e.g., excess weight) acquired in childhood and adolescence have a good chance of being carried into adulthood. In this sense, seeking to understand which factors can influence these habits and/or characteristics is of paramount importance. One of these factors that can influence the health of children and adolescents are the lifestyle habits and characteristics of these young people's parents. One of the lifestyle habits that appears to be related between parents and children is physical activity. However, most studies analyze the practice of physical activity between parents and children only considering the practice of total physical activity, that is, not considering the different domains of physical activity [ i) physical efforts carried out in the work environment, occupations in the case of adults and in the school environment in the case of children and adolescents; ii) physical activities carried out during leisure time; iii) physical activities carried out in the form of active commuting], in addition to there being little information considering the different intensities of physical activity (light, moderate, vigorous and very vigorous). Another gap to be addressed is the relationship between other health variables between parents and children, including unhealthy lifestyle habits, such as smoking, eating disorders and symptoms of anxiety and depression, as well as adverse health conditions, such as the presence of chronic diseases. and overweight, would be different considering the parents' practice of physical activity, for example; whether the possible relationship between excess weight between parents and children would be similar in children of physically active parents when compared to children of insufficiently active parents. Therefore, the objective of the present study will be to verify whether the different domains and intensities of physical activity are related between parents and children, as well as to verify whether other lifestyle habits and health characteristics are related between parents and children, considering the levels of activity. physical status of parents (physically active and insufficiently active).
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents (sons and daughters) | – | Other: No interventionThe study will consist of children and adolescents from six years of age. |
| Parents (mothers and fathers) | – | –The study will consist of children and adolescents from six years of age and at least one of their biological parents to be evaluated. |
Who may qualify
- Ages
- 6 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The project will be carried out with children and adolescents from six years of age. The project will be publicized through social media, such as Facebook, WhatsApp, Instagram and also through television and radio. Participants who are interested in participating in the project and appear at the FCT-UNESP premises; parents must sign the informed consent form authorizing their children to participate in the study, as well as parents must also sign the consent form also agreeing to participate in the study (since this project will evaluate the health parameters of parents and children). Furthermore, children and adolescents must sign a consent form agreeing to participate in the study.
Key inclusion criteria (1 listed)
- Children and adolescent over 6 years old.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionWe will not carry out any type of intervention, just observe the behaviors and health parameters of parents and children. | Other | Children and adolescents (sons and daughters) |
Primary outcome
Objective measure of physical activity
Time frame: Baseline
The objective measurement of physical activity will be performed using the Actigraph GT3X accelerometer (ActiGraph, LLC, Pensacola, FL, USA). Evaluated will remain with the equipment for five full days (three weekdays and two weekend days).
Subjective measure of physical activity
Time frame: Baseline
Physical activity in different domains will be assessed using the questionnaire by Baecke et al. (1982). This instrument assesses the practice of physical activity through 16 questions in the last twelve months considering physical effort at work (for adults) and at school (for children and adolescents), the practice of sports activities or systematic exercises during leisure time and activities occupation in free time. In the field of work or school (in the case of children and adolescents), issues relating to physical efforts carried out at work are investigated, such as: time spent sitting, standing and walking in the work environment, carrying weights, whether the subject being assessed sweats a lot at work and how tired you feel after a day of work. In the leisure domain, leisure-time physical activity is considered, such as exercising at the gym or playing sports.
18 secondary outcomes
Practice of physical activity in childhood and adolescence
Time frame: Baseline
Sedentary behavior (subjective measure)
Time frame: Baseline
Sedentary behavior (objective measure)
Time frame: Baseline
Blood pressure
Time frame: Baseline
Height
Time frame: Baseline
Body mass
Time frame: Baseline
Body mass index
Time frame: Baseline
Waist circumference
Time frame: Baseline
Autonomic Cardiac Modulation
Time frame: Baseline
Bone Mineral Density
Time frame: Baseline
Quality of life - Adults
Time frame: Baseline
Quality of life - Children and adolescents
Time frame: Baseline
Anxiety and depression
Time frame: Baseline
Stress
Time frame: Baseline
Musculoskeletal symptoms
Time frame: Baseline
Quality of sleep
Time frame: Baseline
Sleep latency
Time frame: Baseline
Eating habits
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Fathers and Mothers and Children and Adolescents, Boys and Girls, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective measure of physical activity (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.