NCT03360058

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:

  1. 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. 2.To increase GP/ primary care staff knowledge of and confidence in their role in raising the issue of weight management,
  3. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

1.1 years

First QC Date

November 27, 2017

Last Update Submit

November 21, 2018

Conditions

Keywords

motivational techniquesprimary care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Implementation/ Normalization

    12 months

  • Percentage of diabetes reviews with recorded weight management discussion in LES template

    12 months

  • Training uptake

    12 months

Study Arms (2)

Immediate access to STBD training

EXPERIMENTAL

Immediate access to training materials and print pieces to support implementation

Behavioral: Small Talk Big Difference Immediate access training

Delayed access to STBD training

PLACEBO COMPARATOR

Delayed access to training materials and print pieces

Behavioral: Small Talk Big Difference delayed access training

Interventions

Immediate access to 1 hour online training and supporting print materials for implementation in primary care practice

Immediate access to STBD training

Delayed access (by 4 months) to 1 hour online training and supporting print materials for implementation in primary care practice

Delayed access to STBD training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • "17c" practices (those with a separate contract for long term conditions)
  • Those practices with a database shared with another practice (8 practices in area)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glasgow Cardiovascular Research Centre

Glasgow, Scotland, G12 8TA, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jennifer Logue, MBChB PhD

    Glasgow University and NHS GGC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 2, 2017

Study Start

October 7, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations