Type 2 DiabetesNCT02845791
PRE-STARt Intervention - Trial of an Interactive Family Based Lifestyle Programme
A study testing Interactive Lifestyle programme workshop in people with Type 2 Diabetes and Chronic Disease, run by University Hospitals, Leicester at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Chronic Disease, Obesity
- What is being tested?
- Interactive Lifestyle programme workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Leicester
Leicester, LE4 5PW
About this study
Official title: Prevention Strategies for Adolescents at Risk of Diabetes - A Randomised Controlled Trial of an Interactive Family-based Lifestyle Programme
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).
Read the 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
- Being tested
- Interactive Lifestyle programme workshop
- Medical subject headings
- Diabetes Mellitus, Type 2, Chronic Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Lifestyle programme workshopBehavioural
Participants will attend eight 90 minute sessions of an interactive lifestyle programme along with their parent(s)/guardian(s).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Interactive Lifestyle programme workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post baseline
Secondary outcomes (16)
An increase in 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.
Measured: 3 and 6 months
An increase in the proportion meeting MVPA guidelines
Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.
Measured: 3 and 6 months
Reduction in time spent sedentary
Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.
Measured: 3 and 6 months
Change in physical activity levels
Self reported - questionnaire
Measured: 3 and 6 months
Reduction in Body mass index percentile (BMI)
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
Measured: 3 and 6 months
Change in healthy food provision and parenting practices for healthy food
As parents are active participants in the intervention The Investigators will also query their knowledge and attitudes towards healthy eating and physical activity.
Measured: 3 and 6 months
Improvement in diet composition
The Investigators will query the nutrition habits of participants to investigate any changes in the behaviours targeted in the workshops. A food frequency questionnaire (FFQ) taken from the ISCOLE study that was adapted from the HBSC Study will be used to query the consumption of 23 food categories in a "usual" week. The Investigators will also query breakfast consumption for weekdays and weekends. The Investigators have also created ad hoc questions on other intervention targets of snacking behaviours, fruit and vegetable intake and fizzy drink consumption. This ad hoc method has been used in other international multi-site studies.
Measured: 3 and 6 months
Improvement in knowledge of physical activity and nutrition
The physical activity questionnaire for adolescents (PAQ-A) [62] 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). This questionnaire requests responses for the last 7 days by asking participants to check a list of activities for frequency of participation. This questionnaire has received support from an expert panel and has also high validity against objective measures and moderate reliability.
Measured: 3 and 6 months
Improvement in HbA1c
Biochemical measures (Child only) - HbA1c
Measured: 3 and 6 months
Improvement in Triglycerides
Biochemical measures (Child only) - Triglycerides
Measured: 3 and 6 months
Improvement in Glucose
Biochemical measures (Child only) - Glucose
Measured: 3 and 6 months
Improvement in HDL-C
Biochemical measures (Child only) HDL-C
Measured: 3 and 6 months
Improvement in Total Cholesterol
Biochemical measures (Child only) -Total cholesterol will be measured using a point-of-care testing (POCT) and LDL-C will be calculated.
Measured: 3 and 6 months
Improvement in cardio-metabolic variables
Biochemical measures (Child only) - Capillary blood samples will be taken from each child using the finger prick method. The CardioChek® system will be used as the POCT method. The CardioChek® system is a portable hand held device that requires between 15 to 40 µL capillary sample from a finger-stick for each test. The CardioChek® system is certified by the Cholesterol Reference Method Laboratory Network (CRMLN) and National Cholesterol Education Program (NCEP), is FDA-cleared, CE-marked, internationally registered, and is CLIA-waived by the Centers for Medicare \& Medicaid Services, USA.
Measured: 3 and 6 months
Blood Pressure (Child)
Arterial blood pressure will be measured using an automated sphygmomanometer with an appropriate sized cuff while the patient is seated, and having rested quietly for 5 minutes. Three measurements will be obtained for blood pressure and an average of the last two will be used in any analysis.
Measured: 3 and 6 months
Blood Pressure (Parent(s)/guardian(s))
Arterial blood pressure will be measured using an automated sphygmomanometer with an appropriate sized cuff while the patient is seated, and having rested quietly for 5 minutes. Three measurements will be obtained for blood pressure and an average of the last two will be used in any analysis.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leicester, Associacao Protectora dos Diabeticos de Portugal, The Algarve Regional Health Administration, University of Leipzig, Technische Universität Dresden, Alexander Technological Educational Institute, Thessaloniki, Greece, Diabetes Centre of Paediatrics P&A, Primary Care Centre Egia, San Sebastian, Spain, Basque Government Department of Public Health, Health Department of the Alto/Bajo Deba
- Responsible party
- Sponsor
- Investigators
- Melanie J Davies, MD, Principal investigator, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845791
- Sponsor's protocol ID
- 65436
- Status last verified
- Jan 2019
- First submitted
- 5 May 2016
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Non identifiable participant data will be only be shared with the study collaborators.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Strategies for Adolescents at Risk of Diabetes - A Randomised Controlled Trial of an Interactive Family-based Lifestyle Programme
- ClinicalTrials.gov ID
- NCT02845791
- Acronym / sponsor ID
- 65436
- Conditions
- Type 2 Diabetes, Chronic Disease, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- University of Leicester, Associacao Protectora dos Diabeticos de Portugal, The Algarve Regional Health Administration, University of Leipzig, Technische Universität Dresden, Alexander Technological Educational Institute, Thessaloniki, Greece, Diabetes Centre of Paediatrics P&A, Primary Care Centre Egia, San Sebastian, Spain, Basque Government Department of Public Health, Health Department of the Alto/Bajo Deba
- Study start
- Jul 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Interactive Lifestyle programme workshopThe educational intervention participants will receive the eight 90 minute sessions of an interactive family based lifestyle programme. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
- Family history of Diabetes (first degree relative).
- Non-white ethnicity.
- Watching TV/play computer games for more than 2 hours a day (self-report).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Lifestyle programme workshopParticipants will attend eight 90 minute sessions of an interactive lifestyle programme along with their parent(s)/guardian(s). | Behavioural | Intervention |
Primary outcome
The primary endpoint is to detect a change in objectively measured MVPA of 10 minutes per day within the intervention group at 6 months.
Time frame: 6 months post baseline
Participating children and adults will be asked to wear the wrist worn GENEActiv accelerometer (ActivInsights, Kimbolton, Cambridgeshire, UK) continuously for up to 8 days.
16 secondary outcomes
An increase in total volume of physical activity
Time frame: 3 and 6 months
An increase in the proportion meeting MVPA guidelines
Time frame: 3 and 6 months
Reduction in time spent sedentary
Time frame: 3 and 6 months
Change in physical activity levels
Time frame: 3 and 6 months
Reduction in Body mass index percentile (BMI)
Time frame: 3 and 6 months
Change in healthy food provision and parenting practices for healthy food
Time frame: 3 and 6 months
Improvement in diet composition
Time frame: 3 and 6 months
Improvement in knowledge of physical activity and nutrition
Time frame: 3 and 6 months
Improvement in HbA1c
Time frame: 3 and 6 months
Improvement in Triglycerides
Time frame: 3 and 6 months
Improvement in Glucose
Time frame: 3 and 6 months
Improvement in HDL-C
Time frame: 3 and 6 months
Improvement in Total Cholesterol
Time frame: 3 and 6 months
Improvement in cardio-metabolic variables
Time frame: 3 and 6 months
Blood Pressure (Child)
Time frame: 3 and 6 months
Blood Pressure (Parent(s)/guardian(s))
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: Yes. Non identifiable participant data will be only be shared with the study collaborators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie J Davies, MD principal investigator
University Hospitals, Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Lifestyle programme workshop in people with Type 2 Diabetes and Chronic Disease, run by University Hospitals, Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is to detect a change in objectively measured MVPA of 10 minutes per day within the intervention group at 6 months. (time frame: 6 months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.