Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults
- Conditions
- Diabetes Mellitus, Type 2Overweight and ObesityRisk Reduction
- Interventions
- Behavioral: Healthy lifestyle intervention
- Registration Number
- NCT04217759
- Lead Sponsor
- Universiti Brunei Darussalam
- Brief Summary
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)?'.
The 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.
The 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.
- Detailed Description
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?'.
Study 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- Bruneian including permanent residents
- BMI from 25.00 to 39.99 kg/m2
- American Diabetes Association (ADA) diabetes risk score of at least 3 and maximum score of 8
- Mentally and physically fit with no chronic conditions
- Without medical conditions that could influence glucose metabolism and insulin resistance
- Answered 'No' to all 6 questions in questionnaire-based pre-exercise risk assessment
- Not actively participating in other healthy lifestyle programmes
- Had access to computer or mobile phone with Internet
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Healthy lifestyle intervention 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)
- Primary Outcome Measures
Name Time Method Change in diabetes risk score from week 0 to week 13 12 weeks 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.
- Secondary Outcome Measures
Name Time Method Change in moderate PA MET (min/week) 12 weeks Using SF-IPAQ
Change in walking MET (min/week) 12 weeks Using SF-IPAQ
Change in total PA MET (min/week) 12 weeks Using SF-IPAQ
Change in intake of carbohydrates (servings/day) 12 weeks Using 4-day dietary record
Change in self-efficacy (PA) score 12 weeks Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate better confidence in exercising
Change in resting heart rate (pulse/min) 12 weeks Using OMRON automated blood pressure monitor
Change in waist circumference (WC) (cm) 12 weeks Measured at the midpoint between the lower border of the ribcage and iliac crest with tape measure
Change in weight (%) 12 weeks Using digital weighing scale
Height in cm At baseline Using digital weighing scale
Change in waist-to-hip ratio (WHR) 12 weeks Calculated with WC and HC
Change in weight (kg) 12 weeks Using digital weighing scale
Change in body mass index (BMI) (kg/m2) 12 weeks Calculated with weight and height
Change in hip circumference (HC) (cm) 12 weeks Measured at the largest portion of the buttocks with tape measure
Change in fasting blood glucose (FBG) (mmol/l) 12 weeks With finger-pricking and AccuTrend Plus System blood analyses
Change in fasting blood total cholesterol (TC) (mmol/l) 12 weeks With finger-pricking and AccuTrend Plus System blood analyses
Change in fasting blood triglycerides (TG) (mmol/l) 12 weeks With finger-pricking and AccuTrend Plus System blood analyses
Change in systolic blood pressure (SBP) (mmHg) 12 weeks Using OMRON automated blood pressure monitor
Change in diastolic blood pressure (DBP) (mmHg) 12 weeks Using OMRON automated blood pressure monitor
Change in vigorous PA metabolic task (MET) (min/week) 12 weeks Using short-form international PA questionnaire (SF-IPAQ)
Change in intake of water in (litres/day) 12 weeks Using 4-day dietary record
Change in intake of protein (servings/day) 12 weeks Using 4-day dietary record
Change in intake of fruits (servings/day) 12 weeks Using 4-day dietary record
Change in Intake of vegetables (servings/day) 12 weeks Using 4-day dietary record
Change in sitting time (hrs/day) 12 weeks Using SF-IPAQ
Change in motivation score 12 weeks 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.
Change in social support (diet) score 12 weeks 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.
Change in moral disengagement (diet) score 12 weeks 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
Change in outcome expectations (PA) score 12 weeks 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
Change in social support (PA) score 12 weeks Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate better support for exercising
Change in overcoming barriers (PA) score 12 weeks 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
Change in outcome expectations (diet) score 12 weeks 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
Change in emotional coping (PA) score 12 weeks 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
Facilitation (PA) score 12 weeks 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
Trial Locations
- Locations (1)
PAPRSB Institute of Health Sciences, Universiti Brunei Darussalam
🇧🇳Brunei, Bandar Seri Begawan, Brunei Darussalam