Study Overview

Details

NCTId: NCT02845791

Status: Completed

Condition: Obesity

Study Type: Interventional

Sponsor: University Hospitals, Leicester

Study Description

Brief

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

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 (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.

Healthy Volunteers: Accepts Healthy Volunteers

Gender: All

Min Age: 12 Years

Max Age: 14 Years

Contacts

University Hospitals of Leicester

Leicester

LE4 5PW

United Kingdom

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