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

14. Januar 2019 aktualisiert von: 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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

318

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre bis 14 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: 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.
Sonstiges: Intervention
The educational intervention participants will receive the eight 90 minute sessions of an interactive family based lifestyle programme.
Verhalten: Interactive Lifestyle programme workshop
Participants will attend eight 90 minute sessions of an interactive lifestyle programme along with their parent(s)/guardian(s).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The primary endpoint is to detect a change in objectively measured MVPA of 10 minutes per day within the intervention group at 6 months.
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Hospitals, Leicester

Mitarbeiter

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

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2016

Primärer Abschluss (Tatsächlich)

1. März 2017

Studienabschluss (Tatsächlich)

1. Oktober 2017

Studienanmeldedaten

Zuerst eingereicht

5. Mai 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juli 2016

Zuerst gepostet (Schätzen)

27. Juli 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Januar 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Januar 2019

Zuletzt verifiziert

1. Januar 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 65436

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Ja

Beschreibung des IPD-Plans

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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