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

NCT02845791 | Completed

• 1 other identifier: 65436
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 2 Diabetes; Chronic Disease; Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months post baseline

Secondary Outcomes (16)

• An increase in total volume of physical activity

  3 and 6 months

• An increase in the proportion meeting MVPA guidelines

  3 and 6 months

• Reduction in time spent sedentary

  3 and 6 months

• Change in physical activity levels

  3 and 6 months

• Reduction in Body mass index percentile (BMI)

  3 and 6 months

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

OTHER

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

Behavioral: Interactive Lifestyle programme workshop

Interventions

Interactive Lifestyle programme workshop BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals, Leicester: lead
• University of Leicester: collaborator
• Associacao Protectora dos Diabeticos de Portugal: collaborator
• The Algarve Regional Health Administration: collaborator
• University of Leipzig: collaborator
• Technische Universität Dresden: collaborator
• Alexander Technological Educational Institute, Thessaloniki, Greece: collaborator
• Diabetes Centre of Paediatrics P&A: collaborator
• Primary Care Centre Egia, San Sebastian, Spain: collaborator
• Basque Government Department of Public Health: collaborator
• Health Department of the Alto/Bajo Deba: collaborator

Study Sites (1)

University Hospitals of Leicester

Leicester, LE4 5PW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Chronic Disease; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Study Officials

• Melanie J Davies, MD

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: July 27, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)