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

NCT ID: NCT02845791

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-10-31

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.

Conditions

Type 2 Diabetes; Chronic Disease; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

The control participants will not receive the educational intervention but will be provided with a detailed advice leaflet for themselves and their parents/guardians.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

The educational intervention participants will receive the eight 90 minute sessions of an interactive family based lifestyle programme.

Group Type: OTHER

Interactive Lifestyle programme workshop

Intervention Type: BEHAVIORAL

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

Interventions

Interactive Lifestyle programme workshop

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Leicester

OTHER

Sponsor Role: collaborator

Associacao Protectora dos Diabeticos de Portugal

OTHER

Sponsor Role: collaborator

The Algarve Regional Health Administration

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: collaborator

Alexander Technological Educational Institute, Thessaloniki, Greece

OTHER

Sponsor Role: collaborator

Diabetes Centre of Paediatrics P&A

UNKNOWN

Sponsor Role: collaborator

Primary Care Centre Egia, San Sebastian, Spain

UNKNOWN

Sponsor Role: collaborator

Basque Government Department of Public Health

OTHER

Sponsor Role: collaborator

Health Department of the Alto/Bajo Deba

OTHER

Sponsor Role: collaborator

University Hospitals, Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melanie J Davies, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals, Leicester

Locations

University Hospitals of Leicester

Leicester, , United Kingdom

Countries

United Kingdom

Other Identifiers

65436

Identifier Type: -

Identifier Source: org_study_id