Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01795833 |
| Other study ID # |
13SM0392 |
| Secondary ID |
MR/J000183/1 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 3, 2013 |
| Est. completion date |
November 30, 2017 |
Study information
| Verified date |
October 2020 |
| Source |
Imperial College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Type 2 diabetes is a major healthcare problem in the developed and developing world. Recent
clinical trials have demonstrated that it may be prevented by lifestyle intervention focused
on diet and physical activity. These trials have been expensive and labour intensive and this
has limited translation of the known benefits to the population at large.
We propose using a mobile phone intervention for lifestyle change and will assess it in a
clinical trial(study) in people with impaired glucose regulation (high risk at developing
type 2 diabetes).
The study will be conducted in both India and the UK. The purpose of the study is to assess
the effectiveness and acceptability of a text messaging system to prevent the progression to
diabetes in people with high risk. The study involves five visits to clinic over 2 year
period.
Study participants will be divided into two groups by the computer generated random method -
one is 'Usual Care' group and the other 'Text Messaging' group.
- Usual care will consist of a 30 minute interview, delivering personalized diet and
exercise advice, supplemented by written material and education regarding diabetes. This
will be delivered once at the beginning of the study.
- The intervention group will undergo the same initial interview and, in addition, will
receive 3 times weekly text messaging with education, advice, support and motivation.
These messages will be personalized to individual targets set at the initial interview.
The primary outcome will be progression to diabetes, with and without SMS intervention.
Secondary outcomes will be improvements in physical activity (reported and directly
measured), body weight and other cardiovascular risk factors (blood pressure, total and HDL
cholesterol and serum triglycerides).
Description:
Recruitment:
- Target recruitment number will be 1834 in total (1134 for India and 700 for UK).
- In India people at risk will be ascertained using the Indian Diabetes Risk Score
followed by measurement of a single blood sample to assess glucose regulation (HbA1c) in
those with high scores.
- In the UK, high risk subjects will be ascertained from the National Health service (NHS)
Health Check Scheme and from routine screening in primary care; UK recruitment will also
be based on HbA1c.
Trial Design:
1. Visit 1 (Screening)
- Potential subjects will be invited to clinic for screening to determine their
prediabetic state (defined as an HbA1c of 6.0-6.4%)and suitability to take part in
the study.
- Screening involves clinical measurements, physical measurements and laboratory
measurements. Also, baseline questionnaires will be carried out at this visit.
- ActiGraph, physical activity monitoring device will be fitted on that is to be kept
for 7 days.
2. Visit 2 (Education and Randomization)
- One-to-One structured education on healthy lifestyle will be given to all
successfully screened subjects.
- The subjects then will be randomized using computer generated numbers either to
usual care (control arm) or usual care with text messaging (intervention arm).
3. Visit 3 (6 month follow up), Visit 4 (12 month follow-up) and Visit 5 (24 month
follow-up) - each visit involves
- clinical measurements, physical measurements and laboratory measurements
- Questionnaires
- Fitting ActiGraph on subject
Data:
- During the course of the study visits some data will be stored on laptop computers, not
connected to the internet, for later statistical analysis. These data will be coded and
non identifiable.
- Participant data will be stored in a locked filing cabinet in a secure room in Imperial
College Healthcare NHS Trust. Only the research team (clinical research fellow and
research nurse) will have access to the filing cabinet.
- At the end of each visit the anonymised data will be transferred immediately to the
secure NHS computers and will be deleted from the laptop. Access to NHS computers is
only by members of NHS staff with appropriate log in privileges.
- All data will be stored in an anonymised form by using study numbers for identification
of participants.
- The NHS code of confidentiality will be followed and all activity will meet the
requirements of the data protection act.
- Only members of the clinical research team and those responsible for direct care will
have access to subjects' data during the study.
- The data generated by the study will be analyzed by the research team from Imperial
College. The analysis will be on anonymised data and will take place in Imperial College
Healthcare NHS Trust and in Imperial College academic buildings in the Faculty of
Medicine.
Direct Access to Source Data/Documents:
*The investigator(s)/institution(s) will permit trial-related monitoring, audits, and
regulatory inspection(s), providing direct access to source data/documents.
Statistics:
- Sample size is based on previous data from the Indian Diabetes Prevention studies. We
estimate that the two year conversion rate to diabetes in the control group will be 25%.
A total of 1134 individuals per group are required across both countries to detect a 20%
reduction in risk of progression with 80% power at 5% significance. A study of this size
will be able to address the question of whether, overall, the text messaging system is
effective in reducing progression to diabetes in high risk individuals. It will not be
sufficiently powered to address this question in each country separately, nor to detect
differences of effect between them. However, a study of this size is extremely well
powered to detect an impact on the continuously distributed secondary outcome of
moderate to vigorous physical activity (MVPA) as assessed by Actigraph. The standard
deviation of MVPA in the ProActive trial was 17 minutes per day. Thus the study overall
has >99% power to detect a difference of 4 minutes per day of extra walking between
groups. It will be possible, therefore, to examine country specific effects of the
intervention on MVPA
- Missing, unused, and spurious data will be assessed on an individual basis and may be
ignored, withdrawn or the visit may be removed from the analysis with appropriate
justification adjudicated by the Principal Investigator.
- Data will be analyzed using parametric and nonparametric statistical methods for the
primary and secondary outcomes.
Regulatory Issues:
- Ethics Approval The Chief Investigator has obtained approval from the Westminster
Research Ethics Committee. Local Research and Development(R&D) Approval at each
participating NHS Trust is also required before accepting participants into the study.
The study will be conducted in accordance with the recommendations for physicians
involved in research on human subjects adopted by the 18th World Medical Assembly,
Helsinki 1964 and later revisions.
- Consent to enter the study must be sought from each participant only after a full
explanation has been given, an information leaflet offered and time allowed for
consideration. Signed participant consent should be obtained. The right of the
participant to refuse to participate without giving reasons must be respected. All
participants are free to withdraw at any time from the protocol treatment without giving
reasons and without prejudicing further treatment.
- The Chief Investigator will preserve the confidentiality of participants taking part in
the study and is registered under the Data Protection Act.
- Indemnity Imperial College London holds negligent harm and non-negligent harm insurance
policies which apply to this study.
- Imperial College Academic Health Science Centre will act as the main Sponsor for this
study. Delegated responsibilities will be assigned to the NHS trusts taking part in this
study.
- The study may be subject to inspection and audit by Imperial College London under their
remit as sponsor and other regulatory bodies to ensure adherence to GCP and the NHS
Research Governance Framework for Health and Social Care (2nd edition).
