Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-25 @ 4:20 PM
Study NCT ID:
NCT04217759
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2019-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly allocated into two groups: one group with intervention (intervention group) and another group without intervention (control group).\n\nIntervention group went through a healthy lifestyle intervention using evidence-based SCT strategies emphasising on PA and diet for 12 weeks via face-to-face sessions and social media tools, while the control group only received leaflets on healthy lifestyle with no further guidance.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-02', 'studyFirstSubmitDate': '2019-12-27', 'studyFirstSubmitQcDate': '2020-01-02', 'lastUpdatePostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in diabetes risk score from week 0 to week 13', 'timeFrame': '12 weeks', 'description': 'Using Finnish Diabetes Risk Score (FINDRISC) questionnaire, with minimum score of 0 and maximum score of 22. Score less than 7 as low risk, 7 to 11 as slightly elevated, 12 to 14 as moderate risk, 15 to 20 as high risk and more than 20 as very high risk.'}], 'secondaryOutcomes': [{'measure': 'Change in weight (kg)', 'timeFrame': '12 weeks', 'description': 'Using digital weighing scale'}, {'measure': 'Change in weight (%)', 'timeFrame': '12 weeks', 'description': 'Using digital weighing scale'}, {'measure': 'Height in cm', 'timeFrame': 'At baseline', 'description': 'Using digital weighing scale'}, {'measure': 'Change in body mass index (BMI) (kg/m2)', 'timeFrame': '12 weeks', 'description': 'Calculated with weight and height'}, {'measure': 'Change in waist circumference (WC) (cm)', 'timeFrame': '12 weeks', 'description': 'Measured at the midpoint between the lower border of the ribcage and iliac crest with tape measure'}, {'measure': 'Change in hip circumference (HC) (cm)', 'timeFrame': '12 weeks', 'description': 'Measured at the largest portion of the buttocks with tape measure'}, {'measure': 'Change in waist-to-hip ratio (WHR)', 'timeFrame': '12 weeks', 'description': 'Calculated with WC and HC'}, {'measure': 'Change in fasting blood glucose (FBG) (mmol/l)', 'timeFrame': '12 weeks', 'description': 'With finger-pricking and AccuTrend Plus System blood analyses'}, {'measure': 'Change in fasting blood total cholesterol (TC) (mmol/l)', 'timeFrame': '12 weeks', 'description': 'With finger-pricking and AccuTrend Plus System blood analyses'}, {'measure': 'Change in fasting blood triglycerides (TG) (mmol/l)', 'timeFrame': '12 weeks', 'description': 'With finger-pricking and AccuTrend Plus System blood analyses'}, {'measure': 'Change in systolic blood pressure (SBP) (mmHg)', 'timeFrame': '12 weeks', 'description': 'Using OMRON automated blood pressure monitor'}, {'measure': 'Change in diastolic blood pressure (DBP) (mmHg)', 'timeFrame': '12 weeks', 'description': 'Using OMRON automated blood pressure monitor'}, {'measure': 'Change in resting heart rate (pulse/min)', 'timeFrame': '12 weeks', 'description': 'Using OMRON automated blood pressure monitor'}, {'measure': 'Change in vigorous PA metabolic task (MET) (min/week)', 'timeFrame': '12 weeks', 'description': 'Using short-form international PA questionnaire (SF-IPAQ)'}, {'measure': 'Change in moderate PA MET (min/week)', 'timeFrame': '12 weeks', 'description': 'Using SF-IPAQ'}, {'measure': 'Change in walking MET (min/week)', 'timeFrame': '12 weeks', 'description': 'Using SF-IPAQ'}, {'measure': 'Change in total PA MET (min/week)', 'timeFrame': '12 weeks', 'description': 'Using SF-IPAQ'}, {'measure': 'Change in sitting time (hrs/day)', 'timeFrame': '12 weeks', 'description': 'Using SF-IPAQ'}, {'measure': 'Change in intake of carbohydrates (servings/day)', 'timeFrame': '12 weeks', 'description': 'Using 4-day dietary record'}, {'measure': 'Change in intake of protein (servings/day)', 'timeFrame': '12 weeks', 'description': 'Using 4-day dietary record'}, {'measure': 'Change in intake of fruits (servings/day)', 'timeFrame': '12 weeks', 'description': 'Using 4-day dietary record'}, {'measure': 'Change in Intake of vegetables (servings/day)', 'timeFrame': '12 weeks', 'description': 'Using 4-day dietary record'}, {'measure': 'Change in intake of water in (litres/day)', 'timeFrame': '12 weeks', 'description': 'Using 4-day dietary record'}, {'measure': 'Change in motivation score', 'timeFrame': '12 weeks', 'description': 'Using University of Rhode Island Change Assessment (URICA) with minimum score of -2 and maximum score of 14. The higher the score, the higher the motivation.'}, {'measure': 'Change in social support (diet) score', 'timeFrame': '12 weeks', 'description': 'Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate better support for eating healthy.'}, {'measure': 'Change in social support (PA) score', 'timeFrame': '12 weeks', 'description': 'Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate better support for exercising'}, {'measure': 'Change in overcoming barriers (PA) score', 'timeFrame': '12 weeks', 'description': 'Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate more capabilities to overcome barriers towards exercising'}, {'measure': 'Change in moral disengagement (diet) score', 'timeFrame': '12 weeks', 'description': 'Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate lack of control in eating'}, {'measure': 'Change in outcome expectations (diet) score', 'timeFrame': '12 weeks', 'description': 'Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate more positive expectations for dieting'}, {'measure': 'Change in outcome expectations (PA) score', 'timeFrame': '12 weeks', 'description': 'Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate more positive expectations for exercising'}, {'measure': 'Change in emotional coping (PA) score', 'timeFrame': '12 weeks', 'description': 'Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate better emotional coping by exercising'}, {'measure': 'Change in self-efficacy (PA) score', 'timeFrame': '12 weeks', 'description': 'Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate better confidence in exercising'}, {'measure': 'Facilitation (PA) score', 'timeFrame': '12 weeks', 'description': 'Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate better access to facilities and equipment for exercising'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['social cognitive theory', 'Type 2 diabetes mellitus', 'social media', 'diabetes prevention', 'lifestyle intervention'], 'conditions': ['Overweight and Obesity', 'Risk Reduction', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': "The general research question posed was 'How effective is a healthy lifestyle intervention using behavioural change strategies in the prevention of Type 2 Diabetes Mellitus (T2DM)?'.\n\nThe main aim was to assess the effectiveness of a healthy lifestyle intervention implemented for 12 weeks via face-to-face group sessions and by using social media tools (Facebook and WhatsApp) for young adults at risk of T2DM.\n\nThe hypothesis was that this healthy lifestyle intervention may be effective in terms of initiating an increased physical activity (PA) level and a healthy balanced dietary intake resulting in improvements of other T2DM risk factors at 12 weeks.", 'detailedDescription': "The specific research question posed was 'Is a healthy lifestyle intervention using Social Cognitive Theory (SCT)-based PA and dietary strategies implemented for 12 weeks through face-to-face group sessions and social media tools effective in the initiation and maintenance of increased PA level and healthy balanced dietary intake, resulting in improvements of T2DM risk score, anthropometrics, metabolic parameters and SCT-related psychosocial factors among Bruneian young adults at risk of T2DM?'.\n\nStudy design was two-arm parallel, stratified with simple randomisation, and assessor-blinded randomised controlled trial. Participants were randomly allocated into intervention group and control group. Participants were students and alumni of Universiti Brunei Darussalam and Universiti Teknologi Brunei who were overweight-obese at risk of T2DM with a mean age of 23.1 (2.48) years old. Intervention group went through a healthy lifestyle intervention using evidence-based SCT strategies emphasising on PA and diet for 12 weeks, while the control group only received leaflets on healthy lifestyle with no further guidance. Outcomes measured were changes from baseline at week 0 to post-intervention at week 13 between intervention and control groups. Outcomes were changes in diabetes risk score, anthropometrics, metabolic parameters, PA, dietary intake and SCT-related psychosocial factors, with repeated-measures ANOVA as the main analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Bruneian including permanent residents\n* BMI from 25.00 to 39.99 kg/m2\n* American Diabetes Association (ADA) diabetes risk score of at least 3 and maximum score of 8\n* Mentally and physically fit with no chronic conditions\n* Without medical conditions that could influence glucose metabolism and insulin resistance\n* Answered 'No' to all 6 questions in questionnaire-based pre-exercise risk assessment\n* Not actively participating in other healthy lifestyle programmes\n* Had access to computer or mobile phone with Internet"}, 'identificationModule': {'nctId': 'NCT04217759', 'briefTitle': 'Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Brunei Darussalam'}, 'officialTitle': 'Effectiveness of Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'UBDIHS/13H0621'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Intervention group went through a healthy lifestyle intervention using evidence-based SCT strategies emphasising on PA and diet for 12 weeks via face-to-face sessions and social media tools (Facebook and WhatsApp)', 'interventionNames': ['Behavioral: Healthy lifestyle intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Control group only received leaflets on healthy lifestyle with no further guidance.'}], 'interventions': [{'name': 'Healthy lifestyle intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Be Healthy Camp'], 'description': 'The main goal was to provide knowledge and skills for targeted population in order for them to adapt healthy lifestyle throughout their life. At the end of intervention, participants were expected to be fully equipped with necessary knowledge and fundamental skills in adapting and maintaining healthy lifestyle throughout their life. Gradual improvements were emphasised and at least 5% loss of initial body weight was expected, aiming for at least 0.5% loss in the first month.\n\nIt was divided into three phases (preparation, implementation, maintenance) focusing on PA and diet, in which self-efficacy enhancement and self-regulatory skills were emphasised during the first month of intervention.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BE1410', 'city': 'Brunei', 'state': 'Bandar Seri Begawan', 'country': 'Brunei', 'facility': 'PAPRSB Institute of Health Sciences, Universiti Brunei Darussalam', 'geoPoint': {'lat': 4.89035, 'lon': 114.94006}}], 'overallOfficials': [{'name': "Alifah Nur'ain Haji Mat Rasil", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Brunei Darussalam'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Throughout Ph.D. course completion until research publications', 'ipdSharing': 'YES', 'description': 'All collected data was available only within the research team which consisted of supervisors only:\n\n* Dr Nik Tuah (main supervisor)\n* Dr Mas Rina Wati Hamid (co-supervisor)\n* Assoc Prof Dr Ayub Sadiq (co-supervisor)', 'accessCriteria': "Research team\n\n* Dr Alifah Nur'ain Haji Mat Rasil (principal investigator)\n* Dr Nik Tuah (main supervisor)\n* Dr Mas Rina Wati Hamid (co-supervisor)\n* Assoc Prof Dr Ayub Sadiq (co-supervisor)"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Brunei Darussalam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': "Alifah Nur'ain Haji Mat Rasil", 'investigatorAffiliation': 'Universiti Brunei Darussalam'}}}}