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

14. januar 2019 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

318

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 14 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Andet: Intervention
The educational intervention participants will receive the eight 90 minute sessions of an interactive family based lifestyle programme.
Adfærdsmæssigt: Interactive Lifestyle programme workshop
Participants will attend eight 90 minute sessions of an interactive lifestyle programme along with their parent(s)/guardian(s).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The primary endpoint is to detect a change in objectively measured MVPA of 10 minutes per day within the intervention group at 6 months.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
An increase in total volume of physical activity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 and 6 months
Self reported - questionnaire
3 and 6 months
Reduction in Body mass index percentile (BMI)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 and 6 months
Biochemical measures (Child only) - HbA1c
3 and 6 months
Improvement in Triglycerides
Tidsramme: 3 and 6 months
Biochemical measures (Child only) - Triglycerides
3 and 6 months
Improvement in Glucose
Tidsramme: 3 and 6 months
Biochemical measures (Child only) - Glucose
3 and 6 months
Improvement in HDL-C
Tidsramme: 3 and 6 months
Biochemical measures (Child only) HDL-C
3 and 6 months
Improvement in Total Cholesterol
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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))
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospitals, Leicester

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Melanie J Davies, MD, University Hospitals, Leicester

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2016

Primær færdiggørelse (Faktiske)

1. marts 2017

Studieafslutning (Faktiske)

1. oktober 2017

Datoer for studieregistrering

Først indsendt

5. maj 2016

Først indsendt, der opfyldte QC-kriterier

22. juli 2016

Først opslået (Skøn)

27. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 65436

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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