Development of an internet/mobile phone service pathway for pre-diabetes
| ISRCTN | ISRCTN69270299 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69270299 |
| Secondary identifying numbers | 33540 |
- Submission date
- 16/07/2018
- Registration date
- 18/07/2018
- Last edited
- 22/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Weight loss is vital for the prevention and management of type 2 diabetes. Recent dietary studies have found that significant weight loss can reverse type 2 diabetes by reducing the amount of fat stored around vital organs. It is also known that exercise and physical activity are important for the prevention and management of type 2 diabetes. Although it’s clear that diet and physical activity are effective weight loss tools, maintaining these lifestyle changes is difficult. The researchers have developed an internet and mobile phone supported education and coaching service targeting diet and physical activity using behaviour change techniques and personalised coaching. This study will assess the feasibility of this internet/mobile phone enhanced service pathway for weight loss and weight loss maintenance in those with pre-diabetes.
Who can participate?
Adults aged 18-75 years old with pre-diabetes
What does the study involve?
Participants are asked to join the study through their GP practice. All participants receive treatment which includes internet/mobile phone weight loss advice, education, weight and physical activity tracking, and an online coach. In Phase 1 (week 1-12) participants aim to lose at least 6% of their body weight. This is supported by a diet plan described in the mobile phone app. In Phase 2 (week 12-36) participants are asked to continue weight loss and/or remain below the 6% achieved during phase 1. Participants are asked to attend the clinical research facility for four visits (one screening visit and three metabolic assessments). Metabolic assessments include body fat measures, blood samples and fitness assessment. Throughout the programme, participants may also be asked to participate in focus groups and interviews for their views on the service.
What are the possible benefits and risks of participating?
There are a number of benefits. Weight loss and improvements in lifestyle can reduce the risk of health complications associated with diabetes, and can reduce the amount of fat stored around vital organs. Participants are supported throughout the study by an exercise physiologist and a behavioural psychologist who educates them about the effects of diet on glucose control and encourages them to become more physically active. The disadvantages of this study are that participants are required to attend all of the study visits which takes time. In addition, some individuals may experience discomfort when blood samples are taken.
Where is the study run from?
This study is run from the Clinical Research Facility within the Royal Victoria Infirmary, Newcastle Upon Tyne. North East GP practices are recruiting participants.
When is the study starting and how long is it expected to run for?
March 2017 to December 2019
Who is funding the study?
Changing Health Ltd
Who is the main contact?
1. Dr Sophie Cassidy
Sophie.cassidy@newcastle.ac.uk
2. Dr Djordje Jakovljevic
Djordje.jakovljevic@newcastle.ac.uk
Contact information
Scientific
MoveLab: Physical Activity and Exercise Research group
Institute of Cellular Medicine
4th Floor William Leech Building
Newcastle University
Newcastle Upon Tyne
NE2 4HH
United Kingdom
 ORCID ID |
0000-0002-0228-7274 |
|---|---|
| Phone | +44 (0)191 2088264 |
| sophie.cassidy@ncl.ac.uk |
Study information
| Study design | Non-randomised; Interventional; Design type: Treatment, Prevention, Education or Self-Management, Dietary, Psychological & Behavioural, Physical, Management of Care, Active Monitoring |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | An open non-randomised pilot study to assess acceptability and feasibility of an internet/mobile phone enhanced service pathway for the prevention of type 2 diabetes |
| Study hypothesis | Improving diet and physical activity levels are important in the prevention and management of T2DM, and have been shown to induce weight loss. It is known however that maintaining weight loss is difficult, but using behaviour change techniques, structured education and individual coaching can help. The trialists have developed an internet and mobile phone service which bring together these components. The null hypothesis is that this service will not lead to weight loss at the end of the weight maintenance phase (6 months after baseline). This is a pilot trial to determine the feasibility of the intervention and estimate key parameters for the design of the definitive trial e.g. (SD for continuous outcomes; recruitment rates, retention rates, intervention adherence, enablers, barriers to completing the intervention). |
| Ethics approval(s) | North West-Preston Research Ethics Committee, 03/04/2017, ref: 17/NW/0130 |
| Condition | Type 2 diabetes mellitus |
| Intervention | A single group design. All 40 participants with prediabetes will receive treatment, which will include internet/mobile phone weight loss advice, weight and physical activity tracker, and an online coach. Participants with prediabetes according to fasting plasma glucose (FPG) 5.6–6.9 mmol/L, and/or HbA1c 5.7–6.4% (39–47 mmol/mol), will not have changed their medication, or undergone a weight loss programme in the past year. Subjects will be aged 18-75 years, will not already take part in regular exercise, will not be undergoing any or dietary change, no history of alcohol abuse, no acute or chronic gastrointestinal conditions and must have access to the internet via a smart phone of computer. PART 1: All participants will receive treatment, which will include internet / mobile phone weight loss advice, education, weight and physical activity tracking, and an online coach (n = 80, treatment). In Phase 1 (week 1-12) participants will aim to lose around 6% of their baseline body weight. This will be supported by a diet plan described in the mobile phone app. In Phase 2 (week 12-36) participants will be asked to continue weight loss and/or remain below the 6% achieved during phase 1. PART 2: Participants will be invited to join a focus group and up to 18 individual interviews will be undertaken throughout, to identify enabling factors and barriers to completion of the programme. Part 2 will be initiated later during the programme, once recruitment is underway. The interview topic guides are currently being developed and will be ready to use 6 months after the first recruit to the study. They will be submitted as an amendment in due course. For the duration of the programme, participants will have access to the internet/mobile phone service, to help with weight loss and maintenance. The patient service is accessed via iOS and Android version mobile apps, supplemented by a web app and telephone coaching support. Patients will use the mobile app to log their weight weekly and view graphs of their weight change over time; track their daily activity using the phone’s built-in step counting function; track their food intake through a photo diary using the phone’s camera; set goals related to their food and activity; and book telephone coaching appointments using a live calendar function linked to their coach’s availability. The coach will have access to all data recorded by the patients using the app, and will use this to inform the structure and delivery of each telephone coaching appointment. The coach will be able to view progress and will offer up to 1x20 (first phone call) + 8x10 coaching sessions over the duration of the programme. The app also provides 6 modules of structured learning content featuring animated videos, illustrated articles, and interactives (e.g. Shopping List Switches, Carbohydrate Calculator, Action Planning demonstrations). In addition, patients can review their progress and access the learning content via the accompanying web app - providing constant access should their mobile phone become lost or inactive during the study. Metabolic control, urine/stool samples, cardiorespiratory function, body composition, physical activity, food frequency questionnaire and wellbeing will be assessed at baseline, after weight loss (Phase 1 – week 13) and weight maintenance (Phase 2 – week 37). All measurements and interviews will be taken at the Clinical research facility, RVI, Newcastle Upon Tyne. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. The feasibility of recruitment, including length of time required to complete patient recruitment and retention rates, monitored throughout the study through screening and recruitment records and follow-up contact with patients. 2. Adherence to and completion of the intervention, assessed through focus groups and individual interviews at the end of the intervention 3. Delivery of intervention components by lifestyle coaches (i.e. in accordance to the protocol), assessed through focus groups and individual interviews at the end of the intervention 4. Enabling factors and barriers to completion of the programme and effective implementation, assessed through focus groups and individual interviews at the end of the intervention |
| Secondary outcome measures | 1. Body composition measured using BODPOD at months 0, 3 and 9 2. Metabolic control measured using fasting blood samples at months 0, 3 and 9 3. Fitness assessed using cardiopulmonary exercise testing at months 0, 3 and 9 4. Cardiac function measured using non-invasive cardiac output monitoring at months 0, 3 and 9 |
| Overall study start date | 24/03/2017 |
| Overall study end date | 19/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 40; UK Sample Size: 40 |
| Total final enrolment | 23 |
| Participant inclusion criteria | 1. Prediabetes based on FPG 5.6–6.9 mmol/L and/or HbA1c 5.7–6.4% (39–47 mmol/mol) 2. No previous diagnosis of Type 2 diabetes 3. Age ≥ 18 years – 75 years 4. BMI ≥ 25 5. Weight stable for the past 6 months 6. Access to a computer, internet and smart mobile phone 7. Happy and able to use a smart mobile phone 8. Willing and able to provide written informed consent 9. Willing to wear the activity monitor for 7 days 10. Willing to undertake study activities including the BODPOD |
| Participant exclusion criteria | 1. Inability to speak or read English 2. Insulin treated 3. Contraindications to exercise determined at the exercise screening 4. Contraindications to weight loss 5. Mental or physical incapacity which makes self management inappropriate 6. Pregnancy, planning pregnancy, or lactating 7. Unable to meaningfully participate for the full duration of the study 8. Participated in a research study within the last 6 months 9. Have any allergies which are related to any of the study procedures |
| Recruitment start date | 19/07/2018 |
| Recruitment end date | 19/12/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Ayesha Clark
Freeman Hospital
Freeman Road
High Heaton
Newcastle Upon Tyne
NE7 7DN
England
United Kingdom
"ROR" |
https://ror.org/05p40t847 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/04/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The trial protocol will be published in due course. Planned publication of the trial results in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to lack of patient consent. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 26/11/2019 | 05/12/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
22/10/2020: The intention to publish date was changed from 01/09/2020 to 01/04/2021.
29/01/2020: The following changes have been made:
1. The intention to publish date has been changed from 01/06/2021 to 01/09/2020.
2. The total final enrolment number has been added.
05/12/2019: Publication reference added.
25/04/2019: The condition has been changed from "Specialty: Diabetes, Primary sub-specialty: Type 2; UKCRC code/ Disease: Metabolic and Endocrine/ Diabetes mellitus" to "Type 2 diabetes mellitus" following a request from the NIHR.
26/03/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 19/02/2019 to 19/12/2019.
2. The overall end date was changed from 19/12/2019 to 19/10/2020.
3. The intention to publish date was changed from 01/12/2020 to 01/06/2021.
