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

Obesity Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Chronic Disease
• Obesity
• Type 2 Diabetes

• NCT number: NCT02845791
• Study type: Interventional
• Source: University Hospitals, Leicester
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Completion date: October 2017