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

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:

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Weight Management
• Intervention / Treatment: Behavioral: Small Talk Big Difference Immediate access training; Behavioral: Small Talk Big Difference delayed access training

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 8TA
      • Glasgow Cardiovascular Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate access to STBD training; Immediate access to training materials and print pieces to support implementation	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
Placebo Comparator: Delayed access to STBD training; Delayed access to training materials and print pieces	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation/ Normalization	NOMAD questionnaire will be used to ascertain how STBD impacts on primary care clinicians work	12 months
Percentage of diabetes reviews with recorded weight management discussion in LES template	percentage of diabetes review in primary care	12 months
Training uptake	Training uptake - online, face to face and experiential; By practice; By GP and practice Nurse By diabetes lead	12 months

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow
• Investigators: Principal Investigator: Jennifer Logue, MBChB PhD, Glasgow University and NHS GGC

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: primary care; motivational techniques
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Body Weight
• Other Study ID Numbers: GN17DI319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No