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Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults

Effectiveness of Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults: a Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04217759
Enrollment
71
Registered
2020-01-03
Start date
2017-10-01
Completion date
2018-02-27
Last updated
2020-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Overweight and Obesity, Risk Reduction

Keywords

social cognitive theory, Type 2 diabetes mellitus, social media, diabetes prevention, lifestyle intervention

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.

Interventions

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. It 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.

Sponsors

Universiti Brunei Darussalam
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Participants were randomly allocated into two groups: one group with intervention (intervention group) and another group without intervention (control group). 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, while the control group only received leaflets on healthy lifestyle with no further guidance.

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in diabetes risk score from week 0 to week 1312 weeksUsing 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

MeasureTime frameDescription
Change in weight (%)12 weeksUsing digital weighing scale
Height in cmAt baselineUsing digital weighing scale
Change in body mass index (BMI) (kg/m2)12 weeksCalculated with weight and height
Change in waist circumference (WC) (cm)12 weeksMeasured at the midpoint between the lower border of the ribcage and iliac crest with tape measure
Change in hip circumference (HC) (cm)12 weeksMeasured at the largest portion of the buttocks with tape measure
Change in waist-to-hip ratio (WHR)12 weeksCalculated with WC and HC
Change in fasting blood glucose (FBG) (mmol/l)12 weeksWith finger-pricking and AccuTrend Plus System blood analyses
Change in fasting blood total cholesterol (TC) (mmol/l)12 weeksWith finger-pricking and AccuTrend Plus System blood analyses
Change in fasting blood triglycerides (TG) (mmol/l)12 weeksWith finger-pricking and AccuTrend Plus System blood analyses
Change in systolic blood pressure (SBP) (mmHg)12 weeksUsing OMRON automated blood pressure monitor
Change in diastolic blood pressure (DBP) (mmHg)12 weeksUsing OMRON automated blood pressure monitor
Change in resting heart rate (pulse/min)12 weeksUsing OMRON automated blood pressure monitor
Change in vigorous PA metabolic task (MET) (min/week)12 weeksUsing short-form international PA questionnaire (SF-IPAQ)
Change in moderate PA MET (min/week)12 weeksUsing SF-IPAQ
Change in walking MET (min/week)12 weeksUsing SF-IPAQ
Change in total PA MET (min/week)12 weeksUsing SF-IPAQ
Change in weight (kg)12 weeksUsing digital weighing scale
Change in intake of carbohydrates (servings/day)12 weeksUsing 4-day dietary record
Change in intake of protein (servings/day)12 weeksUsing 4-day dietary record
Change in intake of fruits (servings/day)12 weeksUsing 4-day dietary record
Change in Intake of vegetables (servings/day)12 weeksUsing 4-day dietary record
Change in intake of water in (litres/day)12 weeksUsing 4-day dietary record
Change in motivation score12 weeksUsing 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) score12 weeksUsing 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 social support (PA) score12 weeksUsing 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) score12 weeksUsing 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 moral disengagement (diet) score12 weeksUsing 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 (diet) score12 weeksUsing 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 outcome expectations (PA) score12 weeksUsing 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 emotional coping (PA) score12 weeksUsing social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate better emotional coping by exercising
Change in self-efficacy (PA) score12 weeksUsing social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate better confidence in exercising
Facilitation (PA) score12 weeksUsing 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
Change in sitting time (hrs/day)12 weeksUsing SF-IPAQ

Countries

Brunei

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026