Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults
Primary Purpose
Overweight and Obesity, Risk Reduction, Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Brunei Darussalam
Study Type
Interventional
Intervention
Healthy lifestyle intervention
Sponsored by

About this trial
This is an interventional prevention trial for Overweight and Obesity focused on measuring social cognitive theory, Type 2 diabetes mellitus, social media, diabetes prevention, lifestyle intervention
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
Sites / Locations
- PAPRSB Institute of Health Sciences, Universiti Brunei Darussalam
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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)
Control group only received leaflets on healthy lifestyle with no further guidance.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in weight (kg)
Using digital weighing scale
Change in weight (%)
Using digital weighing scale
Height in cm
Using digital weighing scale
Change in body mass index (BMI) (kg/m2)
Calculated with weight and height
Change in waist circumference (WC) (cm)
Measured at the midpoint between the lower border of the ribcage and iliac crest with tape measure
Change in hip circumference (HC) (cm)
Measured at the largest portion of the buttocks with tape measure
Change in waist-to-hip ratio (WHR)
Calculated with WC and HC
Change in fasting blood glucose (FBG) (mmol/l)
With finger-pricking and AccuTrend Plus System blood analyses
Change in fasting blood total cholesterol (TC) (mmol/l)
With finger-pricking and AccuTrend Plus System blood analyses
Change in fasting blood triglycerides (TG) (mmol/l)
With finger-pricking and AccuTrend Plus System blood analyses
Change in systolic blood pressure (SBP) (mmHg)
Using OMRON automated blood pressure monitor
Change in diastolic blood pressure (DBP) (mmHg)
Using OMRON automated blood pressure monitor
Change in resting heart rate (pulse/min)
Using OMRON automated blood pressure monitor
Change in vigorous PA metabolic task (MET) (min/week)
Using short-form international PA questionnaire (SF-IPAQ)
Change in moderate PA MET (min/week)
Using SF-IPAQ
Change in walking MET (min/week)
Using SF-IPAQ
Change in total PA MET (min/week)
Using SF-IPAQ
Change in sitting time (hrs/day)
Using SF-IPAQ
Change in intake of carbohydrates (servings/day)
Using 4-day dietary record
Change in intake of protein (servings/day)
Using 4-day dietary record
Change in intake of fruits (servings/day)
Using 4-day dietary record
Change in Intake of vegetables (servings/day)
Using 4-day dietary record
Change in intake of water in (litres/day)
Using 4-day dietary record
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.
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.
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
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
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
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
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
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
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
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
Full Information
NCT ID
NCT04217759
First Posted
December 27, 2019
Last Updated
January 2, 2020
Sponsor
Universiti Brunei Darussalam
1. Study Identification
Unique Protocol Identification Number
NCT04217759
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
February 27, 2018 (Actual)
Study Completion Date
February 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Brunei Darussalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Risk Reduction, Diabetes Mellitus, Type 2
Keywords
social cognitive theory, Type 2 diabetes mellitus, social media, diabetes prevention, lifestyle intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group only received leaflets on healthy lifestyle with no further guidance.
Intervention Type
Behavioral
Intervention Name(s)
Healthy lifestyle intervention
Other Intervention Name(s)
Be Healthy Camp
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in diabetes risk score from week 0 to week 13
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in weight (kg)
Description
Using digital weighing scale
Time Frame
12 weeks
Title
Change in weight (%)
Description
Using digital weighing scale
Time Frame
12 weeks
Title
Height in cm
Description
Using digital weighing scale
Time Frame
At baseline
Title
Change in body mass index (BMI) (kg/m2)
Description
Calculated with weight and height
Time Frame
12 weeks
Title
Change in waist circumference (WC) (cm)
Description
Measured at the midpoint between the lower border of the ribcage and iliac crest with tape measure
Time Frame
12 weeks
Title
Change in hip circumference (HC) (cm)
Description
Measured at the largest portion of the buttocks with tape measure
Time Frame
12 weeks
Title
Change in waist-to-hip ratio (WHR)
Description
Calculated with WC and HC
Time Frame
12 weeks
Title
Change in fasting blood glucose (FBG) (mmol/l)
Description
With finger-pricking and AccuTrend Plus System blood analyses
Time Frame
12 weeks
Title
Change in fasting blood total cholesterol (TC) (mmol/l)
Description
With finger-pricking and AccuTrend Plus System blood analyses
Time Frame
12 weeks
Title
Change in fasting blood triglycerides (TG) (mmol/l)
Description
With finger-pricking and AccuTrend Plus System blood analyses
Time Frame
12 weeks
Title
Change in systolic blood pressure (SBP) (mmHg)
Description
Using OMRON automated blood pressure monitor
Time Frame
12 weeks
Title
Change in diastolic blood pressure (DBP) (mmHg)
Description
Using OMRON automated blood pressure monitor
Time Frame
12 weeks
Title
Change in resting heart rate (pulse/min)
Description
Using OMRON automated blood pressure monitor
Time Frame
12 weeks
Title
Change in vigorous PA metabolic task (MET) (min/week)
Description
Using short-form international PA questionnaire (SF-IPAQ)
Time Frame
12 weeks
Title
Change in moderate PA MET (min/week)
Description
Using SF-IPAQ
Time Frame
12 weeks
Title
Change in walking MET (min/week)
Description
Using SF-IPAQ
Time Frame
12 weeks
Title
Change in total PA MET (min/week)
Description
Using SF-IPAQ
Time Frame
12 weeks
Title
Change in sitting time (hrs/day)
Description
Using SF-IPAQ
Time Frame
12 weeks
Title
Change in intake of carbohydrates (servings/day)
Description
Using 4-day dietary record
Time Frame
12 weeks
Title
Change in intake of protein (servings/day)
Description
Using 4-day dietary record
Time Frame
12 weeks
Title
Change in intake of fruits (servings/day)
Description
Using 4-day dietary record
Time Frame
12 weeks
Title
Change in Intake of vegetables (servings/day)
Description
Using 4-day dietary record
Time Frame
12 weeks
Title
Change in intake of water in (litres/day)
Description
Using 4-day dietary record
Time Frame
12 weeks
Title
Change in motivation score
Description
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.
Time Frame
12 weeks
Title
Change in social support (diet) score
Description
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.
Time Frame
12 weeks
Title
Change in social support (PA) score
Description
Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate better support for exercising
Time Frame
12 weeks
Title
Change in overcoming barriers (PA) score
Description
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
Time Frame
12 weeks
Title
Change in moral disengagement (diet) score
Description
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
Time Frame
12 weeks
Title
Change in outcome expectations (diet) score
Description
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
Time Frame
12 weeks
Title
Change in outcome expectations (PA) score
Description
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
Time Frame
12 weeks
Title
Change in emotional coping (PA) score
Description
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
Time Frame
12 weeks
Title
Change in self-efficacy (PA) score
Description
Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate better confidence in exercising
Time Frame
12 weeks
Title
Facilitation (PA) score
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alifah Nur'ain Haji Mat Rasil
Organizational Affiliation
University Brunei Darussalam
Official's Role
Principal Investigator
Facility Information:
Facility Name
PAPRSB Institute of Health Sciences, Universiti Brunei Darussalam
City
Brunei
State/Province
Bandar Seri Begawan
ZIP/Postal Code
BE1410
Country
Brunei Darussalam
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data was available only within the research team which consisted of supervisors only:
Dr Nik Tuah (main supervisor)
Dr Mas Rina Wati Hamid (co-supervisor)
Assoc Prof Dr Ayub Sadiq (co-supervisor)
IPD Sharing Time Frame
Throughout Ph.D. course completion until research publications
IPD Sharing Access Criteria
Research team
Dr Alifah Nur'ain Haji Mat Rasil (principal investigator)
Dr Nik Tuah (main supervisor)
Dr Mas Rina Wati Hamid (co-supervisor)
Assoc Prof Dr Ayub Sadiq (co-supervisor)
Learn more about this trial
Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults
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