Clinical trial NCT04217759: Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults
Official title: Effectiveness of Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Risk Reduction
Diabetes Mellitus, Type 2
Keywords: social cognitive theory
Type 2 diabetes mellitus
social media
diabetes prevention
lifestyle intervention
Lead sponsor: Universiti Brunei Darussalam
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in diabetes risk score from week 0 to week 13
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in weight (kg)
timeFrame: 12 weeks
measure: Change in weight (%)
timeFrame: 12 weeks
measure: Height in cm
timeFrame: At baseline
measure: Change in body mass index (BMI) (kg/m2)
timeFrame: 12 weeks
measure: Change in waist circumference (WC) (cm)
timeFrame: 12 weeks
measure: Change in hip circumference (HC) (cm)
timeFrame: 12 weeks
measure: Change in waist-to-hip ratio (WHR)
timeFrame: 12 weeks
measure: Change in fasting blood glucose (FBG) (mmol/l)
timeFrame: 12 weeks
measure: Change in fasting blood total cholesterol (TC) (mmol/l)
timeFrame: 12 weeks
measure: Change in fasting blood triglycerides (TG) (mmol/l)
timeFrame: 12 weeks
measure: Change in systolic blood pressure (SBP) (mmHg)
timeFrame: 12 weeks
measure: Change in diastolic blood pressure (DBP) (mmHg)
timeFrame: 12 weeks
measure: Change in resting heart rate (pulse/min)
timeFrame: 12 weeks
measure: Change in vigorous PA metabolic task (MET) (min/week)
timeFrame: 12 weeks
measure: Change in moderate PA MET (min/week)
timeFrame: 12 weeks
measure: Change in walking MET (min/week)
timeFrame: 12 weeks
measure: Change in total PA MET (min/week)
timeFrame: 12 weeks
measure: Change in sitting time (hrs/day)
timeFrame: 12 weeks
measure: Change in intake of carbohydrates (servings/day)
timeFrame: 12 weeks
measure: Change in intake of protein (servings/day)
timeFrame: 12 weeks
measure: Change in intake of fruits (servings/day)
timeFrame: 12 weeks
measure: Change in Intake of vegetables (servings/day)
timeFrame: 12 weeks
measure: Change in intake of water in (litres/day)
timeFrame: 12 weeks
measure: Change in motivation score
timeFrame: 12 weeks
measure: Change in social support (diet) score
timeFrame: 12 weeks
measure: Change in social support (PA) score
timeFrame: 12 weeks
measure: Change in overcoming barriers (PA) score
timeFrame: 12 weeks
measure: Change in moral disengagement (diet) score
timeFrame: 12 weeks
measure: Change in outcome expectations (diet) score
timeFrame: 12 weeks
measure: Change in outcome expectations (PA) score
timeFrame: 12 weeks
measure: Change in emotional coping (PA) score
timeFrame: 12 weeks
measure: Change in self-efficacy (PA) score
timeFrame: 12 weeks
measure: Facilitation (PA) score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brunei
country: Brunei Darussalam
facility: PAPRSB Institute of Health Sciences, Universiti Brunei Darussalam
state: Bandar Seri Begawan
Study officials:
affiliation: University Brunei Darussalam
name: Alifah Nur'ain Haji Mat Rasil
role: PRINCIPAL_INVESTIGATOR
References: