An interventional study of Interactive Lifestyle programme workshop in Type 2 Diabetes, Chronic Disease and Obesity, sponsored by University Hospitals, Leicester. Completed at 1 site in United Kingdom. Open to participants aged 12 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by University Hospitals, Leicester · Not applicable, Interventional, and Prevention
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).
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))
990 studies on the registry are indexed under Chronic Disease; 179 are open to participants now.
This study's enrollment of 318 is above the median of 120 across 722 interventional studies indexed under Chronic Disease.
Browse Chronic Disease studies →University Hospitals, Leicester is the lead sponsor of 67 studies on the registry; 12 are open to participants now.
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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.
The control participants will not receive the educational intervention but will be provided with a detailed advice leaflet for themselves and their parents/guardians.
The educational intervention participants will receive the eight 90 minute sessions of an interactive family based lifestyle programme.
Behavioral: Interactive Lifestyle programme workshop
Participants will attend eight 90 minute sessions of an interactive lifestyle programme along with their parent(s)/guardian(s).
The primary endpoint is to detect a change in objectively measured MVPA of 10 minutes per day within the intervention group at 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: 6 months post baseline
An increase in total volume of physical activity
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
An increase in the proportion meeting MVPA guidelines
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
Reduction in time spent sedentary
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
Change in physical activity levels
Self reported - questionnaire
Time frame: 3 and 6 months
Reduction in Body mass index percentile (BMI)
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
Change in healthy food provision and parenting practices for healthy food
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
Improvement in diet composition
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
Improvement in knowledge of physical activity and nutrition
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
Improvement in HbA1c
Biochemical measures (Child only) - HbA1c
Time frame: 3 and 6 months
Improvement in Triglycerides
Biochemical measures (Child only) - Triglycerides
Time frame: 3 and 6 months
Improvement in Glucose
Biochemical measures (Child only) - Glucose
Time frame: 3 and 6 months
Improvement in HDL-C
Biochemical measures (Child only) HDL-C
Time frame: 3 and 6 months
Improvement in Total Cholesterol
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
Improvement in cardio-metabolic variables
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
Blood Pressure (Child)
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
Blood Pressure (Parent(s)/guardian(s))
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
Plan to share: Yes — Non identifiable participant data will be only be shared with the study collaborators.
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University Hospitals, Leicester