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Promoting Health in Healthy Living Centres - a Clinical Study Among Children

8. oktober 2019 oppdatert av: Eivind Meland

Promoting Health in Healthy Living Centres - a Clinical Study Among Famililies With Overweight Children

The overall aim is to evaluate if a familybased intervention, targeting overweight and obese children and their parents, has a long-term positive effect on weight development and health of the children. The alternative hypothesis to the zero hypothesis is that the children with overweight and obesity who participate in a one-year intervention together with their parents, both at completion of the six months intervention and at long term follow up will have reduced their BMI-for-age z-score (Iso-BMI) and have adopted healthy habits. The behavioral models and educational strategies will be tailored (by age, gender etc.) and include both general information and practical learning sessions.

Studieoversikt

Detaljert beskrivelse

The investigators intend to perform a controlled clinical trial on interventions on a systemic level.

The target group is overweight and obese children between 6 and 10 years old, their parents, community administrators and public health nurses. The overall aim is to evaluate if a familybased intervention, targeting overweight and obese children and their parents, has a long-term positive effect on weight development of the children. The alternative hypothesis to the zero hypothesis is that the children with overweight and obesity who participate with their parents, both at completion of the six months intervention and at long term follow up (2 years) will have reduced their BMI-for-age z-score (Iso-BMI). The behavioral models and educational strategies will be tailored (by age, gender etc.) and include both general information and practical learning sessions. The program will offer guided active play, defined as spontaneous gross locomotor movement in which children engage to amuse and to occupy themselves.

Parents will attend to workshops intending to increase knowledge and awareness of family structure, healthy eating habits and practical suggestions for implementing healthy behaviors into everyday life. Parents will be educated on how to use these strategies at home, to further support their children in improving their behaviors. This community based study is the support by the local leadership and collaboration with locally based sports clubs. The primary outcome variable, child BMI-for-age z-score will be measured at referral, inclusion, after 6 months, and at 1 and 2 years post intervention. Secondary outcome variables, measured at inclusion and at the end of intervention, are child activity pattern, screen viewing time, eating habits, sleeping patterns and body composition as well as parent BMI, body composition, exercise habits, perception of health, experience of parenthood and level of parental stress.

Physical activity level as well as sleep duration and -quality will be recorded using biaxial accellerometers. A validated food diary will be used. The participants will also be asked to complete a questionnaire including questions about screen viewing time, self-perceived healt, sleeping patterns (children) and perceived autonomy support and autonomous regulations (parents).

Studietype

Intervensjonell

Registrering (Faktiske)

152

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Hordaland
      • Bergen, Hordaland, Norge, 5018
        • University of Bergen
    • Vest-Agder
      • Kristiansand, Vest-Agder, Norge, 4604
        • University of Agder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 år til 10 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Iso-BMI>25,
  • able to participate in activity groups

Exclusion Criteria:

  • Children being unable to participate in activity groups,
  • parents not able to participate in group based and individual counseling

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Intervention group
The intervention groups start the intervention 6 months ahead of the control group.
Children attend to activity groups weekly during the intervention periode.
Parents attend to four sessions of group based dietary counselling
Parents attend to individual counselling focusing on parental skills and family structure
Ingen inngripen: Delayed intervention group
The control groups will start intervention with 6 months delay

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Iso-BMI
Tidsramme: Change at 6 months, 1 year, 2 years
Measure change at 6 month controlled study, and at 1 and 2 years to measure long-term effects
Change at 6 months, 1 year, 2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physical activity level
Tidsramme: 6 months, 1 and 2 years
Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects. We will use SenseWear bi-axial accelerometer to mesa sure physics activity.
6 months, 1 and 2 years
Dietary habits
Tidsramme: 6 months, 1 and 2 years
Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects. We will use a specially designed questionnaire to measure dietary habits.
6 months, 1 and 2 years
Self-perceived health
Tidsramme: 6 months, 1 and 2 years
Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects. We will use KidScreen 10 questionnaire to measure self-perceived health.
6 months, 1 and 2 years

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Autonomous regulation and perceived autonomy support
Tidsramme: 6 months, 1 and 2 years
Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects. We will use Treatment Self-regulation Questionnaire to measure autonomous regulation, and Healt Care Climate Questionnaire to measure autonomy support.
6 months, 1 and 2 years
Motor skills
Tidsramme: 6 months, 1 and 2 years
Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects. We will use Kôrper-koordinationstest fur Kinder to measure motor skills.
6 months, 1 and 2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Eivind Meland, MD, PhD, Dept of Glob Publ Health and Primary Care, University of Bergen

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2014

Primær fullføring (Faktiske)

1. desember 2017

Studiet fullført (Faktiske)

1. desember 2017

Datoer for studieregistrering

Først innsendt

26. oktober 2014

Først innsendt som oppfylte QC-kriteriene

8. november 2014

Først lagt ut (Anslag)

13. november 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. oktober 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • NCT02290171

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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