Effectiveness of Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Change in diabetes risk score from week 0 to week 13
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Intervention 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 (Facebook and WhatsApp)
干预措施: Healthy lifestyle intervention (Behavioral)
Control group
Control group only received leaflets on healthy lifestyle with no further guidance.
结局指标
主要结局
Change in diabetes risk score from week 0 to week 13
时间窗: 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.
次要结局
- Change in walking MET (min/week)(12 weeks)
- Change in moderate PA MET (min/week)(12 weeks)
- Change in total PA MET (min/week)(12 weeks)
- Change in waist circumference (WC) (cm)(12 weeks)
- Change in weight (%)(12 weeks)
- Height in cm(At baseline)
- Change in waist-to-hip ratio (WHR)(12 weeks)
- Change in weight (kg)(12 weeks)
- Change in body mass index (BMI) (kg/m2)(12 weeks)
- Change in hip circumference (HC) (cm)(12 weeks)
- Change in fasting blood glucose (FBG) (mmol/l)(12 weeks)
- Change in fasting blood total cholesterol (TC) (mmol/l)(12 weeks)
- Change in fasting blood triglycerides (TG) (mmol/l)(12 weeks)
- Change in systolic blood pressure (SBP) (mmHg)(12 weeks)
- Change in diastolic blood pressure (DBP) (mmHg)(12 weeks)
- Change in resting heart rate (pulse/min)(12 weeks)
- Change in vigorous PA metabolic task (MET) (min/week)(12 weeks)
- Change in intake of water in (litres/day)(12 weeks)
- Change in intake of protein (servings/day)(12 weeks)
- Change in intake of fruits (servings/day)(12 weeks)
- Change in Intake of vegetables (servings/day)(12 weeks)
- Change in sitting time (hrs/day)(12 weeks)
- Change in intake of carbohydrates (servings/day)(12 weeks)
- Change in motivation score(12 weeks)
- Change in social support (diet) score(12 weeks)
- Change in moral disengagement (diet) score(12 weeks)
- Change in social support (PA) score(12 weeks)
- Change in overcoming barriers (PA) score(12 weeks)
- Change in outcome expectations (PA) score(12 weeks)
- Change in self-efficacy (PA) score(12 weeks)
- Change in outcome expectations (diet) score(12 weeks)
- Change in emotional coping (PA) score(12 weeks)
- Facilitation (PA) score(12 weeks)
研究者
Alifah Nur'ain Haji Mat Rasil
Principal investigator
Universiti Brunei Darussalam