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PRE-STARt Intervention - Trial of an Interactive Family Based Lifestyle Programme

maanantai 14. tammikuuta 2019 päivittänyt: University Hospitals, Leicester

Prevention Strategies for Adolescents at Risk of Diabetes - A Randomised Controlled Trial of an Interactive Family-based Lifestyle Programme

To investigate whether the interactive family based lifestyle programme leads to behaviour change at 6 months with the primary outcome being increased levels of moderate to vigorous physical activity (MVPA).

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

To investigate whether the lifestyle programme results in changes to the following outcomes 3 and 6 months after baseline assessment (Child)

  • An increase in objectively measured total amount of physical activity
  • An increase in the proportion meeting MVPA guidelines (measured objectively)
  • Reduction in time spent sedentary (measured objectively and self-reported)
  • Change in self-reported physical activity
  • Reduction in measures of adiposity (body mass index percentile, per cent body fat)
  • Improvement in psychological factors that may mediate physical activity participation (self-efficacy, motivation, attitudes, social support and enjoyment of physical activity; and physical self-perceptions)
  • Change in healthy food provision and parenting practices for healthy food
  • Improvement in diet composition.
  • Improvement in knowledge of physical activity and nutrition.
  • Improvement in cardio-metabolic variables (blood pressure, glucose, HbA1c, cholesterol)

The Investigators will also include qualitative data collected from:

  • Evaluation forms following each intervention workshop session which will be completed by the Parent/guardian, child and facilitator
  • Feedback from focus groups to be held following completion of the total intervention i.e. 8 sessions

To investigate whether the lifestyle programme results in changes to the following outcomes 3 and 6 months after baseline assessment (Parent(s)/guardian(s))

  • An increase in objectively measured total volume of physical activity
  • An increase in the proportion meeting MVPA guidelines (measured objectively)
  • Reduction in time spent sedentary (measured objectively and self-reported)
  • Change in self-reported physical activity
  • Reduction in measures of adiposity (body mass index percentile, per cent body fat)
  • Change in healthy food provision and parenting practices for healthy food
  • Improvement in diet composition.
  • Improvement in knowledge of physical activity and nutrition.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

318

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

12 vuotta - 14 vuotta (Lapsi)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

Parents/guardians will answer questions in the eligibility questionnaire about their child and family health history. Participants will be invited to participate if they are 12-14 years old inclusive (12 years 0 days to 14 years 354 days old) and are identified as having the following risk factors for development of Type 2 Diabetes (which will be identified from the eligibility questionnaire):

BMI > 95th percentile for age and gender OR

BMI > 85th percentile PLUS one other from the following list:

  • Family history of Diabetes (first degree relative).
  • Non-white ethnicity.
  • Watching TV/play computer games for more than 2 hours a day (self-report).
  • Sugar intake more than 1.5 cans (or 532 ml) of fizzy pop/fruit juice per day (self-report).

Exclusion Criteria:

Young people will not be eligible for participation in the study if they are outside the age range of interest (<11 years and 364 days or >14 years and 1 day), have an existing diagnosis of Type 1 or Type 2 Diabetes, < 85th percentile. Young people will also be excluded if they themselves do not provide written assent or their parent/guardian does not provide written consent.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Ennaltaehkäisy
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Ei väliintuloa: Control
The control participants will not receive the educational intervention but will be provided with a detailed advice leaflet for themselves and their parents/guardians.
Muut: Intervention
The educational intervention participants will receive the eight 90 minute sessions of an interactive family based lifestyle programme.
Käyttäytyminen: Interactive Lifestyle programme workshop
Participants will attend eight 90 minute sessions of an interactive lifestyle programme along with their parent(s)/guardian(s).

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
The primary endpoint is to detect a change in objectively measured MVPA of 10 minutes per day within the intervention group at 6 months.
Aikaikkuna: 6 months post baseline
Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.
6 months post baseline

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
An increase in total volume of physical activity
Aikaikkuna: 3 and 6 months
Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.
3 and 6 months
An increase in the proportion meeting MVPA guidelines
Aikaikkuna: 3 and 6 months
Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.
3 and 6 months
Reduction in time spent sedentary
Aikaikkuna: 3 and 6 months
Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.
3 and 6 months
Change in physical activity levels
Aikaikkuna: 3 and 6 months
Self reported - questionnaire
3 and 6 months
Reduction in Body mass index percentile (BMI)
Aikaikkuna: 3 and 6 months
Body mass will be measured to the nearest 0.1kg and height will be measured to the nearest 0.1 cm using a clinically approved bioelectrical impedance scale and a portable stadiometer, respectively. BMI will be calculated as weight/height2 and will be converted to a BMI percentile based on WHO growth charts
3 and 6 months
Change in healthy food provision and parenting practices for healthy food
Aikaikkuna: 3 and 6 months
As parents are active participants in the intervention The Investigators will also query their knowledge and attitudes towards healthy eating and physical activity.
3 and 6 months
Improvement in diet composition
Aikaikkuna: 3 and 6 months
The Investigators will query the nutrition habits of participants to investigate any changes in the behaviours targeted in the workshops. A food frequency questionnaire (FFQ) taken from the ISCOLE study that was adapted from the HBSC Study will be used to query the consumption of 23 food categories in a "usual" week. The Investigators will also query breakfast consumption for weekdays and weekends. The Investigators have also created ad hoc questions on other intervention targets of snacking behaviours, fruit and vegetable intake and fizzy drink consumption. This ad hoc method has been used in other international multi-site studies.
3 and 6 months
Improvement in knowledge of physical activity and nutrition
Aikaikkuna: 3 and 6 months
The physical activity questionnaire for adolescents (PAQ-A) [62] will be used to assess the Types and context of physical activity in order to investigate changes in the Types of sports/exercise/activities the participating child may participate in (information which is not available from the accelerometer or the majority of other validated self-report questionnaires). This questionnaire requests responses for the last 7 days by asking participants to check a list of activities for frequency of participation. This questionnaire has received support from an expert panel and has also high validity against objective measures and moderate reliability.
3 and 6 months
Improvement in HbA1c
Aikaikkuna: 3 and 6 months
Biochemical measures (Child only) - HbA1c
3 and 6 months
Improvement in Triglycerides
Aikaikkuna: 3 and 6 months
Biochemical measures (Child only) - Triglycerides
3 and 6 months
Improvement in Glucose
Aikaikkuna: 3 and 6 months
Biochemical measures (Child only) - Glucose
3 and 6 months
Improvement in HDL-C
Aikaikkuna: 3 and 6 months
Biochemical measures (Child only) HDL-C
3 and 6 months
Improvement in Total Cholesterol
Aikaikkuna: 3 and 6 months
Biochemical measures (Child only) -Total cholesterol will be measured using a point-of-care testing (POCT) and LDL-C will be calculated.
3 and 6 months
Improvement in cardio-metabolic variables
Aikaikkuna: 3 and 6 months
Biochemical measures (Child only) - Capillary blood samples will be taken from each child using the finger prick method. The CardioChek® system will be used as the POCT method. The CardioChek® system is a portable hand held device that requires between 15 to 40 µL capillary sample from a finger-stick for each test. The CardioChek® system is certified by the Cholesterol Reference Method Laboratory Network (CRMLN) and National Cholesterol Education Program (NCEP), is FDA-cleared, CE-marked, internationally registered, and is CLIA-waived by the Centers for Medicare & Medicaid Services, USA.
3 and 6 months
Blood Pressure (Child)
Aikaikkuna: 3 and 6 months
Arterial blood pressure will be measured using an automated sphygmomanometer with an appropriate sized cuff while the patient is seated, and having rested quietly for 5 minutes. Three measurements will be obtained for blood pressure and an average of the last two will be used in any analysis.
3 and 6 months
Blood Pressure (Parent(s)/guardian(s))
Aikaikkuna: 3 and 6 months
Arterial blood pressure will be measured using an automated sphygmomanometer with an appropriate sized cuff while the patient is seated, and having rested quietly for 5 minutes. Three measurements will be obtained for blood pressure and an average of the last two will be used in any analysis.
3 and 6 months

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

University Hospitals, Leicester

Yhteistyökumppanit

University of Leipzig
Technische Universität Dresden
University of Leicester
The Algarve Regional Health Administration
Alexander Technological Educational Institute, Thessaloniki, Greece
Diabetes Centre of Paediatrics P&A
Primary Care Centre Egia, San Sebastian, Spain
Basque Government Department of Public Health
Health Department of the Alto/Bajo Deba
Associacao Protectora dos Diabeticos de Portugal

Tutkijat

  • Päätutkija: Melanie J Davies, MD, University Hospitals, Leicester

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Perjantai 1. heinäkuuta 2016

Ensisijainen valmistuminen (Todellinen)

Keskiviikko 1. maaliskuuta 2017

Opintojen valmistuminen (Todellinen)

Sunnuntai 1. lokakuuta 2017

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 5. toukokuuta 2016

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 22. heinäkuuta 2016

Ensimmäinen Lähetetty (Arvio)

Keskiviikko 27. heinäkuuta 2016

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 16. tammikuuta 2019

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 14. tammikuuta 2019

Viimeksi vahvistettu

Tiistai 1. tammikuuta 2019

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 65436

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

Joo

IPD-suunnitelman kuvaus

Non identifiable participant data will be only be shared with the study collaborators.

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