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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
  • Diego Giulliano Destro Christofaro

    Presidente Prudente, São Paulo, 19060-900

    Diego GD Christofaro, PhD, +551832295713, ddcleite@yahoo.com.br

    Recruiting

Other trials in Brazil

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 groups in NCT06248164
Study groupRoleWhat 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. Blood pressure

    Blood pressure will be assessed using an Omron automatic blood pressure measuring device (Model HEM-742, Japan).

    Measured: Baseline

  5. Height

    Height will be measured standing up, with a fixed stadiometer and with individuals barefoot, will be displayed in centimeters.

    Measured: Baseline

  6. 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

  7. 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

  8. Waist circumference

    Abdominal obesity will be determined by waist circumference, using an inextensible metallic tape, will be displayed in centimeters.

    Measured: Baseline

  9. Autonomic Cardiac Modulation

    The heart rate variability will be collected by means of the POLAR V800

    Measured: Baseline

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. Sleep latency

    Sleep latency will be investigated using the Pittsburg questionnaire (BUYSSE et al., 1989).

    Measured: Baseline

  18. 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.

  1. First posted8 Feb 2024
  2. Study start1 Nov 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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)
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

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.

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