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

University Hospitals, Leicester318 enrolled

Overview

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) * 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

318

Conditions

Type 2 Diabetes Chronic Disease Obesity

Interventions

Interactive Lifestyle programme workshopBEHAVIORAL

Participants will attend eight 90 minute sessions of an interactive lifestyle programme along with their parent(s)/guardian(s).

Eligibility

Sex: ALLMin age: 12 YearsMax age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University Hospitals of Leicester

Leicester, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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