University Hospitals of Leicester
Leicester, LE4 5PW, United Kingdom
NCT Number: NCT02845791
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).
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Notify Me12 year–14 year
All sexes
Interventional
Not applicable
Leicester, LE4 5PW, United Kingdom
To investigate whether the lifestyle programme results in changes to the following outcomes 3 and 6 months after baseline assessment (Child)
The Investigators will also include qualitative data collected from:
To investigate whether the lifestyle programme results in changes to the following outcomes 3 and 6 months after baseline assessment (Parent(s)/guardian(s))
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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:
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.
Participants will attend eight 90 minute sessions of an interactive lifestyle programme along with their parent(s)/guardian(s).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 and 6 months
Self reported - questionnaire
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 and 6 months
Biochemical measures (Child only) - HbA1c
Time frame: 3 and 6 months
Biochemical measures (Child only) - Triglycerides
Time frame: 3 and 6 months
Biochemical measures (Child only) - Glucose
Time frame: 3 and 6 months
Biochemical measures (Child only) HDL-C
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
University Hospitals, Leicester
Other
Prevention Strategies for Adolescents at Risk of Diabetes - A Randomised Controlled Trial of an Interactive Family-based Lifestyle Programme
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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