Clinical trial NCT02845791: PRE-STARt Intervention - Trial of an Interactive Family Based Lifestyle Programme
Official title: Prevention Strategies for Adolescents at Risk of Diabetes - A Randomised Controlled Trial of an Interactive Family-based Lifestyle Programme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Chronic Disease
Obesity
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
Collaborators: name: University of Leicester
name: Associacao Protectora dos Diabeticos de Portugal
name: The Algarve Regional Health Administration
name: University of Leipzig
name: Technische Universität Dresden
name: Alexander Technological Educational Institute, Thessaloniki, Greece
name: Diabetes Centre of Paediatrics P&A
name: Primary Care Centre Egia, San Sebastian, Spain
name: Basque Government Department of Public Health
name: Health Department of the Alto/Bajo Deba
First posted: 2016-07-27
Enrollment: 318
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary endpoint is to detect a change in objectively measured MVPA of 10 minutes per day within the intervention group at 6 months.
timeFrame: 6 months post baseline
Secondary outcomes:
measure: An increase in total volume of physical activity
timeFrame: 3 and 6 months
measure: An increase in the proportion meeting MVPA guidelines
timeFrame: 3 and 6 months
measure: Reduction in time spent sedentary
timeFrame: 3 and 6 months
measure: Change in physical activity levels
timeFrame: 3 and 6 months
measure: Reduction in Body mass index percentile (BMI)
timeFrame: 3 and 6 months
measure: Change in healthy food provision and parenting practices for healthy food
timeFrame: 3 and 6 months
measure: Improvement in diet composition
timeFrame: 3 and 6 months
measure: Improvement in knowledge of physical activity and nutrition
timeFrame: 3 and 6 months
measure: Improvement in HbA1c
timeFrame: 3 and 6 months
measure: Improvement in Triglycerides
timeFrame: 3 and 6 months
measure: Improvement in Glucose
timeFrame: 3 and 6 months
measure: Improvement in HDL-C
timeFrame: 3 and 6 months
measure: Improvement in Total Cholesterol
timeFrame: 3 and 6 months
measure: Improvement in cardio-metabolic variables
timeFrame: 3 and 6 months
measure: Blood Pressure (Child)
timeFrame: 3 and 6 months
measure: Blood Pressure (Parent(s)/guardian(s))
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
Study officials:
affiliation: University Hospitals, Leicester
name: Melanie J Davies, MD
role: PRINCIPAL_INVESTIGATOR
References: