Weight ManagementSTBDNCT03360058
Obesity and Type 2 Diabetes - Raising the Issue of Weight Management in Primary Care
A study testing Small Talk Big Difference Immediate access training and Small Talk Big Difference delayed access training in people with Weight Management and Diabetes Mellitus, Type 2, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Weight Management, Diabetes Mellitus, Type 2
- What is being tested?
- Small Talk Big Difference Immediate access training and Small Talk Big Difference delayed access training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Oct 2017to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- "17c" practices (those with a separate contract for long term conditions)
- Those practices with a database shared with another practice (8 practices in area)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Glasgow Cardiovascular Research Centre
Glasgow, Scotland, G12 8TA
About this study
Official title: Obesity and Type 2 Diabetes - Raising the Issue of Weight Management in Primary Care (Small Talk Big Difference)
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.
Read the 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.
- Conditions
- Weight Management, Diabetes Mellitus, Type 2
- Being tested
- Small Talk Big Difference Immediate access training, Small Talk Big Difference delayed access training
- Keywords
- motivational techniques, primary care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Talk Big Difference Immediate access trainingBehavioural
Immediate access to 1 hour online training and supporting print materials for implementation in primary care practice
Small Talk Big Difference delayed access trainingBehavioural
Delayed access (by 4 months) to 1 hour online training and supporting print materials for implementation in primary care practice
| Study group | Role | What they receive |
|---|---|---|
| Immediate access to STBD training | Experimental | Immediate access to training materials and print pieces to support implementation Receives: Behavioral: Small Talk Big Difference Immediate access training |
| Delayed access to STBD training | Placebo comparator | Delayed access to training materials and print pieces Receives: Behavioral: Small Talk Big Difference delayed access training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
Implementation/ Normalization
NOMAD questionnaire will be used to ascertain how STBD impacts on primary care clinicians work
Measured: 12 months
Percentage of diabetes reviews with recorded weight management discussion in LES template
percentage of diabetes review in primary care
Measured: 12 months
Training uptake
Training uptake - online, face to face and experiential
- By practice
- By GP and practice Nurse By diabetes lead
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start7 Oct 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Jennifer Logue, MBChB PhD, Principal investigator, Glasgow University and NHS GGC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360058
- Sponsor's protocol ID
- GN17DI319
- Acronym
- STBD
- Status last verified
- Nov 2018
- First submitted
- 27 Nov 2017
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30767902
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and Type 2 Diabetes - Raising the Issue of Weight Management in Primary Care (Small Talk Big Difference)
- ClinicalTrials.gov ID
- NCT03360058
- Acronym / sponsor ID
- STBD / GN17DI319
- Conditions
- Weight Management, Diabetes Mellitus, Type 2
- Keywords
- motivational techniques, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 7 Oct 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Immediate access to STBD training | Experimental | Behavioral: Small Talk Big Difference Immediate access trainingImmediate access to training materials and print pieces to support implementation |
| Delayed access to STBD training | Placebo comparator | Behavioral: Small Talk Big Difference delayed access trainingDelayed access to training materials and print pieces |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- "17c" practices (those with a separate contract for long term conditions)
- Those practices with a database shared with another practice (8 practices in area)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small Talk Big Difference Immediate access trainingImmediate access to 1 hour online training and supporting print materials for implementation in primary care practice | Behavioural | Immediate access to STBD training |
| Small Talk Big Difference delayed access trainingDelayed access (by 4 months) to 1 hour online training and supporting print materials for implementation in primary care practice | Behavioural | Delayed access to STBD training |
Primary outcome
Measure the effectiveness of an online training programme, practice implementation toolkit and face to face training for primary care staff
Time frame: 12 months
which will be measured as number of patient referrals and patient attendance at NHS funded weight management services
3 secondary outcomes
Implementation/ Normalization
Time frame: 12 months
Percentage of diabetes reviews with recorded weight management discussion in LES template
Time frame: 12 months
Training uptake
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Derived from this study: PubMed 30767902Brooksbank 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Logue, MBChB PhD principal investigator
Glasgow University and NHS GGC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small Talk Big Difference Immediate access training and Small Talk Big Difference delayed access training in people with Weight Management and Diabetes Mellitus, Type 2, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the effectiveness of an online training programme, practice implementation toolkit and face to face training for primary care staff (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03360058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.