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Development of an internet/mobile phone service pathway for pre-diabetes

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN69270299
Enrollment
40
Registered
2018-07-18
Start date
2018-07-19
Completion date
Unknown
Last updated
2020-11-02

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

Conditions

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

Interventions

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 coa

Sponsors

The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026