Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04217759
• Other study ID #: UBDIHS/13H0621
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: February 27, 2018

Study information

• Verified date: January 2020
• Source: Universiti Brunei Darussalam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 27, 2018
• Est. primary completion date: February 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Healthy lifestyle intervention
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.

Locations

Country	Name	City	State
Brunei Darussalam	PAPRSB Institute of Health Sciences, Universiti Brunei Darussalam	Brunei	Bandar Seri Begawan

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Brunei Darussalam

Country where clinical trial is conducted

Brunei Darussalam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in diabetes risk score from week 0 to week 13	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.	12 weeks
Secondary	Change in weight (kg)	Using digital weighing scale	12 weeks
Secondary	Change in weight (%)	Using digital weighing scale	12 weeks
Secondary	Height in cm	Using digital weighing scale	At baseline
Secondary	Change in body mass index (BMI) (kg/m2)	Calculated with weight and height	12 weeks
Secondary	Change in waist circumference (WC) (cm)	Measured at the midpoint between the lower border of the ribcage and iliac crest with tape measure	12 weeks
Secondary	Change in hip circumference (HC) (cm)	Measured at the largest portion of the buttocks with tape measure	12 weeks
Secondary	Change in waist-to-hip ratio (WHR)	Calculated with WC and HC	12 weeks
Secondary	Change in fasting blood glucose (FBG) (mmol/l)	With finger-pricking and AccuTrend Plus System blood analyses	12 weeks
Secondary	Change in fasting blood total cholesterol (TC) (mmol/l)	With finger-pricking and AccuTrend Plus System blood analyses	12 weeks
Secondary	Change in fasting blood triglycerides (TG) (mmol/l)	With finger-pricking and AccuTrend Plus System blood analyses	12 weeks
Secondary	Change in systolic blood pressure (SBP) (mmHg)	Using OMRON automated blood pressure monitor	12 weeks
Secondary	Change in diastolic blood pressure (DBP) (mmHg)	Using OMRON automated blood pressure monitor	12 weeks
Secondary	Change in resting heart rate (pulse/min)	Using OMRON automated blood pressure monitor	12 weeks
Secondary	Change in vigorous PA metabolic task (MET) (min/week)	Using short-form international PA questionnaire (SF-IPAQ)	12 weeks
Secondary	Change in moderate PA MET (min/week)	Using SF-IPAQ	12 weeks
Secondary	Change in walking MET (min/week)	Using SF-IPAQ	12 weeks
Secondary	Change in total PA MET (min/week)	Using SF-IPAQ	12 weeks
Secondary	Change in sitting time (hrs/day)	Using SF-IPAQ	12 weeks
Secondary	Change in intake of carbohydrates (servings/day)	Using 4-day dietary record	12 weeks
Secondary	Change in intake of protein (servings/day)	Using 4-day dietary record	12 weeks
Secondary	Change in intake of fruits (servings/day)	Using 4-day dietary record	12 weeks
Secondary	Change in Intake of vegetables (servings/day)	Using 4-day dietary record	12 weeks
Secondary	Change in intake of water in (litres/day)	Using 4-day dietary record	12 weeks
Secondary	Change in motivation score	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.	12 weeks
Secondary	Change in social support (diet) score	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.	12 weeks
Secondary	Change in social support (PA) score	Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate better support for exercising	12 weeks
Secondary	Change in overcoming barriers (PA) score	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	12 weeks
Secondary	Change in moral disengagement (diet) score	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	12 weeks
Secondary	Change in outcome expectations (diet) score	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	12 weeks
Secondary	Change in outcome expectations (PA) score	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	12 weeks
Secondary	Change in emotional coping (PA) score	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	12 weeks
Secondary	Change in self-efficacy (PA) score	Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate better confidence in exercising	12 weeks
Secondary	Facilitation (PA) score	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	12 weeks