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A randomised controlled trial of an interactive family-based lifestyle programme

PRE-STARt (Phase 2): a randomised controlled trial of an interactive family-based lifestyle programme

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57111126
Enrollment
270
Registered
2016-05-31
Start date
2016-05-02
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

Randomised controlled trial across 5 European sites (locally approved and co-ordinated) to test the effectiveness of a series of 8 lifestyle workshop sessions to see whether this will lead to increase

Sponsors

University Hospitals of Leicester (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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: 1. Family history of Diabetes (first degree relative) 2. Non-white ethnicity 3. Watching TV/play computer games for more than 2 hours a day (self-report) 4. Sugar intake more than 1.5 cans (or 532 ml) of fizzy pop/fruit juice per day (self-report)

Exclusion criteria

Exclusion criteria: 1. Outside the age range of interest (14 years and 1 day) 2. Have an existing diagnosis of Type 1 or Type 2 Diabetes 3. BMI < 85th percentile 4. Young people will also be excluded if they themselves do not provide written assent or their parent/guardian does not provide written consent

Design outcomes

Primary

MeasureTime frame
Objectively measured physical activity and sedentary behaviour levels at 6 months (parent(s)/guardian(s) and child): Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.

Secondary

MeasureTime frame
Measured at 3 and 6 months after baseline assessment: 1. Objectively measured total volume of physical activity: Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days. 2. Proportion meeting MVPA guidelines (measured objectively) 3. Time spent sedentary (measured objectively and self-reported) 4. Self-reported physical activity: The physical activity questionnaire for adolescents (PAQ-A) will be used to assess the Types and context of physical activity in order to investigate changes in the Types of sports/exercise/activities the participating child may participate in (information which is not available from the accelerometer or the majority of other validated self-report questionnaires). 5. Measures of adiposity (body mass index percentile, percent body fat): Body mass will be measured to the nearest 0.1kg and height will be measured to the nearest 0.1 cm using a clinically approved bioelectrical impedance scale and a portable stadiometer, respectively. BMI will be calculated as weight/height2 and will be converted to a BMI percentile based on WHO growth charts. Body fat percentage will be measured to the nearest 1% also using the bioelectrical impedance scale. All circumferences will be measured with an inelastic anthropometry tape. Waist circumference will be measured to the nearest 0.1 cm as the midpoint between the lower costal margin and iliac crest. 6. Psychological factors that may mediate physical activity participation: Participating children will also complete a questions assessing self-efficacy for increasing physical activity, decreasing sedentary behaviour and making positive dietary changes that have been used previously. The Investigators will also collect data on motivation for physical activity change, attitudes towards physical activity and nutrition, barriers to nutritional change and perceived social support for physical activit

Countries

United Kingdom

Contacts

Public ContactGeorgina Surridge

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026