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Does adding facilitated behaviour change improve outcomes for people with recently diagnosed diabetes?

Does adding a facilitated behaviour change intervention improve outcomes among people with recently diagnosed type 2 diabetes receiving intensive treatment in General Practice?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN99175498
Enrollment
1400
Registered
2001-05-02
Start date
2001-10-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

Recruited practices have been randomised to screening for diabetes followed by Routine Care (RC) according to national guidelines or screening followed by Intensive multifactorial intervention (I). We

Sponsors

University of Cambridge (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 40-69 with a diabetes risk score more than or equal to 0.17 (representing the top 25% of risk distribution) are invited for a random capillary screening test for diabetes. Patients are eligible to take part if the diagnosis of diabetes is confirmed by subsequent fasting capillary test and oral glucose tolerance test. Following the funded extension, inclusion criteria extended to include patients aged 40 to 69 years with type 2 diabetes diagnosed within the last 3 years.

Exclusion criteria

Exclusion criteria: Potential participants are excluded if they are pregnant or lactating, have a psychotic illness or have an illness with a likely prognosis of less than 1 year.

Design outcomes

Primary

MeasureTime frame
The principal comparisons between I1 and I2 include changes in weight, self-reported physical activity (IPAQ, EPAQ2), diet (Food Frequency Questionnaire), medication adherence (MARS), smoking status and differences at 1 year in objectively measured physical activity (PAR, CSA [accelerometer]), diet (plasma vitamin C) and medication adherence (plasma drug levels). A cross domain measure of behaviour change at 1 year is under development. Modelled 5-year risk of cardiovascular events, incorporating glycaemia, blood pressure and lipid levels, represents the main outcome for the trial of intensive treatment (RC vs I). In addition, we propose to assess at all levels along our causal pathway psychological measures (illness perceptions, attitudes and intentions towards targeted healthy behaviours), anthropometric variables (weight, body fat distribution and waist circumference) and biochemical parameters (HbA1c, cholesterol and albumin/creatinine ratio).

Secondary

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 7, 2026