NCT02845791

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

Prevention Strategies for Adolescents at Risk of Diabetes - A Randomised Controlled Trial of an Interactive Family-based Lifestyle Programme

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: University Hospitals, Leicester · Academic / Other
• Sex: All
• Age: 12 Years – 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 2 Diabetes
• Chronic Disease
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Interactive Lifestyle programme workshop	Participants will attend eight 90 minute sessions of an interactive lifestyle programme along with their parent(s)/guardian(s).

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-03-01
• Completion: 2017-10-01
• First posted: 2016-07-27
• Last updated: 2019-01-16

Locations

1 site across 1 country: United Kingdom