Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-06 @ 12:22 PM
Study NCT ID:
NCT03360058
Status:
COMPLETED
Last Update Posted:
2018-11-23
First Post:
2017-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obesity and Type 2 Diabetes - Raising the Issue of Weight Management in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-21', 'studyFirstSubmitDate': '2017-11-27', 'studyFirstSubmitQcDate': '2017-11-30', 'lastUpdatePostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the effectiveness of an online training programme, practice implementation toolkit and face to face training for primary care staff', 'timeFrame': '12 months', 'description': 'which will be measured as number of patient referrals and patient attendance at NHS funded weight management services'}], 'secondaryOutcomes': [{'measure': 'Implementation/ Normalization', 'timeFrame': '12 months', 'description': 'NOMAD questionnaire will be used to ascertain how STBD impacts on primary care clinicians work'}, {'measure': 'Percentage of diabetes reviews with recorded weight management discussion in LES template', 'timeFrame': '12 months', 'description': 'percentage of diabetes review in primary care'}, {'measure': 'Training uptake', 'timeFrame': '12 months', 'description': 'Training uptake - online, face to face and experiential\n\n* By practice\n* By GP and practice Nurse By diabetes lead'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['motivational techniques', 'primary care'], 'conditions': ['Weight Management', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '30767902', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': '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.\n\nSpecific aims of the whole project:\n\n1. 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\n2. To increase GP/ primary care staff knowledge of and confidence in their role in raising the issue of weight management,\n3. 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\n4. 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.', 'detailedDescription': "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.\n\nSimilarly, 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.\n\nEngaging 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.\n\nEven 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* GP practices in NHS Greater Glasgow and Clyde which:\n* Have a contract for local enhanced services for long term conditions (Diabetes)\n* Have a unique clinical database (i.e. not shared with another practice)\n\nExclusion Criteria:\n\n* "17c" practices (those with a separate contract for long term conditions)\n* Those practices with a database shared with another practice (8 practices in area)'}, 'identificationModule': {'nctId': 'NCT03360058', 'acronym': 'STBD', 'briefTitle': 'Obesity and Type 2 Diabetes - Raising the Issue of Weight Management in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Glasgow and Clyde'}, 'officialTitle': 'Obesity and Type 2 Diabetes - Raising the Issue of Weight Management in Primary Care (Small Talk Big Difference)', 'orgStudyIdInfo': {'id': 'GN17DI319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate access to STBD training', 'description': 'Immediate access to training materials and print pieces to support implementation', 'interventionNames': ['Behavioral: Small Talk Big Difference Immediate access training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Delayed access to STBD training', 'description': 'Delayed access to training materials and print pieces', 'interventionNames': ['Behavioral: Small Talk Big Difference delayed access training']}], 'interventions': [{'name': 'Small Talk Big Difference Immediate access training', 'type': 'BEHAVIORAL', 'description': 'Immediate access to 1 hour online training and supporting print materials for implementation in primary care practice', 'armGroupLabels': ['Immediate access to STBD training']}, {'name': 'Small Talk Big Difference delayed access training', 'type': 'BEHAVIORAL', 'description': 'Delayed access (by 4 months) to 1 hour online training and supporting print materials for implementation in primary care practice', 'armGroupLabels': ['Delayed access to STBD training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G12 8TA', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Glasgow Cardiovascular Research Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Jennifer Logue, MBChB PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glasgow University and NHS GGC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Glasgow', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}