Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-03 @ 12:07 PM
Study NCT ID:
NCT03644134
Status:
COMPLETED
Last Update Posted:
2018-08-23
First Post:
2018-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-22', 'studyFirstSubmitDate': '2018-08-18', 'studyFirstSubmitQcDate': '2018-08-22', 'lastUpdatePostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': '6 months', 'description': 'Measurement of body weight at the site visit pre/post the intervention'}, {'measure': 'Change in BMI', 'timeFrame': '6 months', 'description': 'Measurement of BMI at the site visit pre/post the intervention'}, {'measure': 'Change in HbA1c', 'timeFrame': '6 month', 'description': 'Measurement of HbA1c at the site visit pre/post the intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 2 Diabetes, Physiological Stress, Sleep Pattern'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Globally, type 2 diabetes mellitus (DM) and obesity are considered to be the fastest growing disorders and their prevalence has increased dramatically over the last twenty years.\n\nRecent studies have shown that about 19% of UAE population has been diagnosed with DM and 57% of Emirati patients with type 2 DM are obese.\n\nOptimal glycemic control and weight management involve comprehensive lifestyle approaches including nutrition recommendations and adequate levels of physical activity.\n\nHowever, recent views have suggested that there are other factors, such as sleep deprivation and stress, contribute to development of type 2 DM.\n\nTaking into account the previous findings, the present study was designed to investigate the effects of a personalized intervention on weight and glycemic control in Emirati patients with type 2 DM. The intervention involves assessment and modification of sleep patterns and stress levels.', 'detailedDescription': 'The present study is a randomized controlled trial which was conducted at Rashid Centre for Diabetes and Research (RCDR) in Ajman which in one of the seven Emirates of the United Arab Emirates (UAE). The study was approved by the research ethics committee of Al Qassimi Clinical Research Centre, Al Qassimi Hospital (Ministry of Health, UAE).\n\nThe study population is comprised of Emirati individuals (n = 51) who attending RCDR diabetes clinics in a quarterly basis (an initial visit and three follow-up visits per annum). The participants were recruited from RCDR diabetes clinics and through different methods including (i) direct contact (ii) distribution of informative flyers and (iii) phone calls using Diamond, an electronic medical database of RCDR patients. The screening process involved 110 Emirati patients with T2DM and 51 individuals were eligible to participate in the present trial based on the following inclusion and exclusion criteria. The inclusion criteria were (i) Age between 18-60 years (ii) Body Mass Index (BMI \\> 25 Kg/m2) and (iii) T2DM. The exclusion criteria were (i) Age \\< 18 and \\> 60 years (ii) BMI \\< 25 Kg/m2) (iii) type 1 DM (iv) diagnosis of atrial fibrillation and/or atrial flutter and/or bundle branch block and (v) heart transplantation.\n\nThe eligible participants were randomly allocated into an intervention group (n = 26) and or into a control group (n = 25). Non-compliance was the main obstacle to maintain the same number of the randomized participants in each group and 19% and 24 % of the participants in the intervention and control group, respectively, did not attend the first visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-60 years\n* Body Mass Index (BMI \\> 25 Kg/m2)\n* T2DM\n\nExclusion Criteria:\n\n* Age \\< 18 and \\> 60 years\n* BMI \\< 25 Kg/m2)\n* Type 1 DM\n* Diagnosis of atrial fibrillation and/or atrial flutter and/or bundle branch block heart transplantation'}, 'identificationModule': {'nctId': 'NCT03644134', 'briefTitle': 'A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns', 'organization': {'class': 'OTHER', 'fullName': 'Rashid Centre for Diabetes and Research'}, 'officialTitle': 'A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns in Obese Type 2 Diabetes Emirati Patients: a Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'RashidCDR'}, 'secondaryIdInfos': [{'id': 'University of Sharjah', 'type': 'OTHER', 'domain': 'University of Sharjah'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Assessment of physiological stress and sleep pattern intervention consists of (i) information session (ii) pre-assessment (first assessment) of stress and recovery levels, and sleep patterns (iii) individual feedback sessions and action plans based on the outcomes of the initial assessment (iv) monitoring and follow-ups (v) post-assessment (second assessment) of stress and recovery levels and sleep patterns', 'interventionNames': ['Behavioral: Assessment of physiological stress and sleep pattern']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The control protocol only includes (i) information session (ii) pre-assessment (initial assessment and (iii) post-assessment (second assessment) of stress and recovery levels and sleep patterns.'}], 'interventions': [{'name': 'Assessment of physiological stress and sleep pattern', 'type': 'BEHAVIORAL', 'description': 'The personalized intervention consists of (i) information session (ii) pre-assessment (first assessment) of stress and recovery levels, and sleep patterns (iii) individual feedback sessions and action plans based on the outcomes of the initial assessment (iv) monitoring and follow-ups (v) post-assessment (second assessment) of stress and recovery levels and sleep patterns.', 'armGroupLabels': ['Intervention Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rashid Centre for Diabetes and Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Bashair Mussa', 'investigatorAffiliation': 'University of Sharjah'}}}}