Obesity and Type 2 Diabetes - Raising the Issue of Weight Management in Primary Care

Diabetes Mellitus, Type 2 Clinical Trial

— STBD  

Official title:

Obesity and Type 2 Diabetes - Raising the Issue of Weight Management in Primary Care (Small Talk Big Difference)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360058
• Other study ID #: GN17DI319
• Status: Completed
• Phase: N/A
• Start date: October 7, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: November 2018
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To ensure that patients who are overweight or obese and have type 2 diabetes are identified, receive personalised diabetes care, have the issue of weight raised and explained in a non-judgemental manner by staff in primary care, and are referred on to weight management services as appropriate ensuring equity of access across NHS Greater Glasgow and Clyde.

Specific aims of the whole project:

1. To improve GP/ primary care staff knowledge of the evidence base for the management of diabetes when there is co-existing obesity and local care pathways

2. To increase GP/ primary care staff knowledge of and confidence in their role in raising the issue of weight management,

3. To improve primary care referral rates of appropriate patients who are overweight or obese and have type 2 diabetes, and are "ready to change" to NHS funded weight management services

4. To improve patient uptake of and attendance at NHS funded weight management services NB This is a service evaluation of a training programme being delivered by NHS Greater Glasgow and Clyde Health Improvement. Full ethical approvals are being sought due to the randomised design and so that results can be generalised and published.

Description:

The Glasgow and Clyde weight management service (GCWMS) delivers a specialist multi-disciplinary, multi-component weight management programme throughout the Glasgow and Clyde area. In a recent evaluation of the service, the authors highlighted that 27% of the patients who are referred to the programme do not opt into the service. This describes patients who are referred via their GP practice and do not contact the service to opt into an initial assessment.

Similarly, Brook et al described initial uptake and engagement of a small weight management programme of 502 patients. In addition to completing an extensive questionnaire, patients were requested to call to make an appointment with the service personally. Of those referred to the programme, 46% did not opt in.

Engaging patients in a weight management programme is especially difficult, even when the intervention is provided via the primary care route. For example, The Counterweight Project, a weight management programme delivered via the GP surgery, has been taken up by a number of surgeries in Scotland, however after 2 years, one fifth of enlisted practices failed to enrol patients onto the programme.

Even when GP's do address matters of weight related behaviour, there is often disagreement from the patient that the topic has been raised. In a sample of 456 patients, 39% of patients disagreed with GP reporting about the content of the discussion during consultations regarding weight, diet and physical activity. In particular, GP's reported more occasions of discussing weight than patients in 12.5% of consultations. Patients' likeliness to engage in a weight management programme is also influenced by practice endorsement and opinion of the GP of the intervention available in addition to other factors: clear understanding of the programme, clear understanding of the programme goals, structured pro-active follow-up and perception of positive outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• GP practices in NHS Greater Glasgow and Clyde which:

• Have a contract for local enhanced services for long term conditions (Diabetes)

• Have a unique clinical database (i.e. not shared with another practice)

Exclusion Criteria:

• "17c" practices (those with a separate contract for long term conditions)

• Those practices with a database shared with another practice (8 practices in area)

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Weight Management

Intervention

Behavioral:
• Small Talk Big Difference Immediate access training
Immediate access to 1 hour online training and supporting print materials for implementation in primary care practice
• Small Talk Big Difference delayed access training
Delayed access (by 4 months) to 1 hour online training and supporting print materials for implementation in primary care practice

Locations

Country	Name	City	State
United Kingdom	Glasgow Cardiovascular Research Centre	Glasgow	Scotland

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the effectiveness of an online training programme, practice implementation toolkit and face to face training for primary care staff	which will be measured as number of patient referrals and patient attendance at NHS funded weight management services	12 months
Secondary	Implementation/ Normalization	NOMAD questionnaire will be used to ascertain how STBD impacts on primary care clinicians work	12 months
Secondary	Percentage of diabetes reviews with recorded weight management discussion in LES template	percentage of diabetes review in primary care	12 months
Secondary	Training uptake	Training uptake - online, face to face and experiential; By practice; By GP and practice Nurse By diabetes lead	12 months