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Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217759
Recruitment Status : Completed
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Alifah Nur'ain Haji Mat Rasil, Universiti Brunei Darussalam

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.


Condition or disease Intervention/treatment Phase
Overweight and Obesity Risk Reduction Diabetes Mellitus, Type 2 Behavioral: Healthy lifestyle intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults: a Randomised Controlled Trial
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : February 27, 2018
Actual Study Completion Date : February 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Arm Intervention/treatment
Experimental: 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)
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.

Other Name: Be Healthy Camp

No Intervention: Control group
Control group only received leaflets on healthy lifestyle with no further guidance.



Primary Outcome Measures :
  1. Change in diabetes risk score from week 0 to week 13 [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in weight (kg) [ Time Frame: 12 weeks ]
    Using digital weighing scale

  2. Change in weight (%) [ Time Frame: 12 weeks ]
    Using digital weighing scale

  3. Height in cm [ Time Frame: At baseline ]
    Using digital weighing scale

  4. Change in body mass index (BMI) (kg/m2) [ Time Frame: 12 weeks ]
    Calculated with weight and height

  5. Change in waist circumference (WC) (cm) [ Time Frame: 12 weeks ]
    Measured at the midpoint between the lower border of the ribcage and iliac crest with tape measure

  6. Change in hip circumference (HC) (cm) [ Time Frame: 12 weeks ]
    Measured at the largest portion of the buttocks with tape measure

  7. Change in waist-to-hip ratio (WHR) [ Time Frame: 12 weeks ]
    Calculated with WC and HC

  8. Change in fasting blood glucose (FBG) (mmol/l) [ Time Frame: 12 weeks ]
    With finger-pricking and AccuTrend Plus System blood analyses

  9. Change in fasting blood total cholesterol (TC) (mmol/l) [ Time Frame: 12 weeks ]
    With finger-pricking and AccuTrend Plus System blood analyses

  10. Change in fasting blood triglycerides (TG) (mmol/l) [ Time Frame: 12 weeks ]
    With finger-pricking and AccuTrend Plus System blood analyses

  11. Change in systolic blood pressure (SBP) (mmHg) [ Time Frame: 12 weeks ]
    Using OMRON automated blood pressure monitor

  12. Change in diastolic blood pressure (DBP) (mmHg) [ Time Frame: 12 weeks ]
    Using OMRON automated blood pressure monitor

  13. Change in resting heart rate (pulse/min) [ Time Frame: 12 weeks ]
    Using OMRON automated blood pressure monitor

  14. Change in vigorous PA metabolic task (MET) (min/week) [ Time Frame: 12 weeks ]
    Using short-form international PA questionnaire (SF-IPAQ)

  15. Change in moderate PA MET (min/week) [ Time Frame: 12 weeks ]
    Using SF-IPAQ

  16. Change in walking MET (min/week) [ Time Frame: 12 weeks ]
    Using SF-IPAQ

  17. Change in total PA MET (min/week) [ Time Frame: 12 weeks ]
    Using SF-IPAQ

  18. Change in sitting time (hrs/day) [ Time Frame: 12 weeks ]
    Using SF-IPAQ

  19. Change in intake of carbohydrates (servings/day) [ Time Frame: 12 weeks ]
    Using 4-day dietary record

  20. Change in intake of protein (servings/day) [ Time Frame: 12 weeks ]
    Using 4-day dietary record

  21. Change in intake of fruits (servings/day) [ Time Frame: 12 weeks ]
    Using 4-day dietary record

  22. Change in Intake of vegetables (servings/day) [ Time Frame: 12 weeks ]
    Using 4-day dietary record

  23. Change in intake of water in (litres/day) [ Time Frame: 12 weeks ]
    Using 4-day dietary record

  24. Change in motivation score [ Time Frame: 12 weeks ]
    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.

  25. Change in social support (diet) score [ Time Frame: 12 weeks ]
    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.

  26. Change in social support (PA) score [ Time Frame: 12 weeks ]
    Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate better support for exercising

  27. Change in overcoming barriers (PA) score [ Time Frame: 12 weeks ]
    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

  28. Change in moral disengagement (diet) score [ Time Frame: 12 weeks ]
    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

  29. Change in outcome expectations (diet) score [ Time Frame: 12 weeks ]
    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

  30. Change in outcome expectations (PA) score [ Time Frame: 12 weeks ]
    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

  31. Change in emotional coping (PA) score [ Time Frame: 12 weeks ]
    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

  32. Change in self-efficacy (PA) score [ Time Frame: 12 weeks ]
    Using social cognitive theory (SCT) constructs scale with minimum score of 1 and maximum score of 4. Higher scores indicate better confidence in exercising

  33. Facilitation (PA) score [ Time Frame: 12 weeks ]
    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



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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217759


Locations
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Brunei Darussalam
PAPRSB Institute of Health Sciences, Universiti Brunei Darussalam
Brunei, Bandar Seri Begawan, Brunei Darussalam, BE1410
Sponsors and Collaborators
Universiti Brunei Darussalam
Investigators
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Principal Investigator: Alifah Nur'ain Haji Mat Rasil University Brunei Darussalam
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Responsible Party: Alifah Nur'ain Haji Mat Rasil, Principal investigator, Universiti Brunei Darussalam
ClinicalTrials.gov Identifier: NCT04217759    
Other Study ID Numbers: UBDIHS/13H0621
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Throughout Ph.D. course completion until research publications
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)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alifah Nur'ain Haji Mat Rasil, Universiti Brunei Darussalam:
social cognitive theory
Type 2 diabetes mellitus
social media
diabetes prevention
lifestyle intervention
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms