Obesity and Type 2 Diabetes - Raising the Issue of Weight Management in Primary Care (STBD)
Primary Purpose
Weight Management, Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Small Talk Big Difference Immediate access training
Small Talk Big Difference delayed access training
Sponsored by
About this trial
This is an interventional other trial for Weight Management focused on measuring motivational techniques, primary care
Eligibility Criteria
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)
Sites / Locations
- Glasgow Cardiovascular Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Immediate access to STBD training
Delayed access to STBD training
Arm Description
Immediate access to training materials and print pieces to support implementation
Delayed access to training materials and print pieces
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Implementation/ Normalization
NOMAD questionnaire will be used to ascertain how STBD impacts on primary care clinicians work
Percentage of diabetes reviews with recorded weight management discussion in LES template
percentage of diabetes review in primary care
Training uptake
Training uptake - online, face to face and experiential
By practice
By GP and practice Nurse By diabetes lead
Full Information
NCT ID
NCT03360058
First Posted
November 27, 2017
Last Updated
November 21, 2018
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
1. Study Identification
Unique Protocol Identification Number
NCT03360058
Brief Title
Obesity and Type 2 Diabetes - Raising the Issue of Weight Management in Primary Care
Acronym
STBD
Official Title
Obesity and Type 2 Diabetes - Raising the Issue of Weight Management in Primary Care (Small Talk Big Difference)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 7, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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:
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
To increase GP/ primary care staff knowledge of and confidence in their role in raising the issue of weight management,
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
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Management, Diabetes Mellitus, Type 2
Keywords
motivational techniques, primary care
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Primary care practices are either assigned to immediate or delayed access to the online training and print pieces with the delayed group acting as our controls for number of referral to weight management services per practice
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate access to STBD training
Arm Type
Experimental
Arm Description
Immediate access to training materials and print pieces to support implementation
Arm Title
Delayed access to STBD training
Arm Type
Placebo Comparator
Arm Description
Delayed access to training materials and print pieces
Intervention Type
Behavioral
Intervention Name(s)
Small Talk Big Difference Immediate access training
Intervention Description
Immediate access to 1 hour online training and supporting print materials for implementation in primary care practice
Intervention Type
Behavioral
Intervention Name(s)
Small Talk Big Difference delayed access training
Intervention Description
Delayed access (by 4 months) to 1 hour online training and supporting print materials for implementation in primary care practice
Primary Outcome Measure Information:
Title
Measure the effectiveness of an online training programme, practice implementation toolkit and face to face training for primary care staff
Description
which will be measured as number of patient referrals and patient attendance at NHS funded weight management services
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Implementation/ Normalization
Description
NOMAD questionnaire will be used to ascertain how STBD impacts on primary care clinicians work
Time Frame
12 months
Title
Percentage of diabetes reviews with recorded weight management discussion in LES template
Description
percentage of diabetes review in primary care
Time Frame
12 months
Title
Training uptake
Description
Training uptake - online, face to face and experiential
By practice
By GP and practice Nurse By diabetes lead
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Logue, MBChB PhD
Organizational Affiliation
Glasgow University and NHS GGC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glasgow Cardiovascular Research Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 8TA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30767902
Citation
Brooksbank K, O'Donnell J, Corbett V, Shield S, Ainsworth R, Shearer R, Montgomery S, Gallagher A, Duncan H, Hamilton L, Laszlo V, Noone R, Baxendale A, Blane D, Logue J. Discussing Weight Management With Type 2 Diabetes Patients in Primary Care Using the Small Talk Big Difference Intervention: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Feb 15;8(2):e12162. doi: 10.2196/12162.
Results Reference
derived
Learn more about this trial
Obesity and Type 2 Diabetes - Raising the Issue of Weight Management in Primary Care
We'll reach out to this number within 24 hrs