'Steps to your healthy future' programme evaluatio

Not Applicable

Completed

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN20770401
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-18
• Study Completion: 2016-04-02
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

1. Patients with a diagnosis of T2D for >1 year and <10 years
2. Patients between the ages of 18 and 70 years
3. Patients with an HbA1c level >7 and <11
4. Patients who commit to attend all of the programme and data collection sessions
5. Patients who are able to give informed consent

Exclusion Criteria

1. Patients who are currently pregnant
2. Patients who cannot read and write in English
3. Patients who are not capable of moderate physical activity
4. Patients who have participated in a research study investigating medical products in the previous 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate whether the Steps 12-month education programme delivered to a population with established T2D (>12 months <10 years duration) can yield a reduction in HbA1c levels of = 0.6%, which represents a clinically significant change in glycaemic control, at 12 months post-baseline.

Secondary Outcome Measures

Name	Time	Method
Evaluate whether the Steps 12-month education programme delivered to a population with established T2D (>12 months <10 years duration) can yield improvements in biomedical measures (to include Cholesterol (Total, HDL, LDL), Blood Pressure, BMI, Weight, Waist, hip and neck circumference), psychosocial measures (to include Learning style preference, Quality of life , Diabetes-related distress, Depression presence and severity, Diabetes self efficacy, Diabetes knowledge , Perceived social support, Readiness to change), and lifestyle outcome measures (to include Smoking status, Alcohol intake, Physical activity, Dietary intake) at 3, 6 and 12 months post baseline session.