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Overweight and ObesityNCT04217759

Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults

A study testing Healthy lifestyle intervention in people with Overweight and Obesity and Risk Reduction, run by Universiti Brunei Darussalam at 1 site in Brunei.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)?'. Read more about this study

Who is it for?
Ages 18 to 29 yearsHealthy volunteers can take part
What is being tested?
Healthy lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteBrunei
Study dates
1 Oct 2017to 27 Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Brunei1 site

  • PAPRSB Institute of Health Sciences, Universiti Brunei Darussalam

    Brunei, Bandar Seri Begawan, BE1410

About this study

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

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.

Read the 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.

Being tested
Healthy lifestyle intervention
Keywords
social cognitive theory, Type 2 diabetes mellitus, social media, diabetes prevention, lifestyle intervention
Medical subject headings
Overweight, Obesity, Risk Reduction Behavior, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy lifestyle interventionBehavioural

    Also called Be Healthy Camp

    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.

Study groups in NCT04217759
Study groupRoleWhat they receive
Intervention groupExperimentalIntervention 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)
Receives: Behavioral: Healthy lifestyle intervention
Control groupNo interventionControl group only received leaflets on healthy lifestyle with no further guidance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

Secondary outcomes (33)

  1. Change in weight (kg)

    Using digital weighing scale

    Measured: 12 weeks

  2. Change in weight (%)

    Using digital weighing scale

    Measured: 12 weeks

  3. Height in cm

    Using digital weighing scale

    Measured: At baseline

  4. Change in body mass index (BMI) (kg/m2)

    Calculated with weight and height

    Measured: 12 weeks

  5. Change in waist circumference (WC) (cm)

    Measured at the midpoint between the lower border of the ribcage and iliac crest with tape measure

    Measured: 12 weeks

  6. Change in hip circumference (HC) (cm)

    Measured at the largest portion of the buttocks with tape measure

    Measured: 12 weeks

  7. Change in waist-to-hip ratio (WHR)

    Calculated with WC and HC

    Measured: 12 weeks

  8. Change in fasting blood glucose (FBG) (mmol/l)

    With finger-pricking and AccuTrend Plus System blood analyses

    Measured: 12 weeks

  9. Change in fasting blood total cholesterol (TC) (mmol/l)

    With finger-pricking and AccuTrend Plus System blood analyses

    Measured: 12 weeks

  10. Change in fasting blood triglycerides (TG) (mmol/l)

    With finger-pricking and AccuTrend Plus System blood analyses

    Measured: 12 weeks

  11. Change in systolic blood pressure (SBP) (mmHg)

    Using OMRON automated blood pressure monitor

    Measured: 12 weeks

  12. Change in diastolic blood pressure (DBP) (mmHg)

    Using OMRON automated blood pressure monitor

    Measured: 12 weeks

  13. Change in resting heart rate (pulse/min)

    Using OMRON automated blood pressure monitor

    Measured: 12 weeks

  14. Change in vigorous PA metabolic task (MET) (min/week)

    Using short-form international PA questionnaire (SF-IPAQ)

    Measured: 12 weeks

  15. Change in moderate PA MET (min/week)

    Using SF-IPAQ

    Measured: 12 weeks

  16. Change in walking MET (min/week)

    Using SF-IPAQ

    Measured: 12 weeks

  17. Change in total PA MET (min/week)

    Using SF-IPAQ

    Measured: 12 weeks

  18. Change in sitting time (hrs/day)

    Using SF-IPAQ

    Measured: 12 weeks

  19. Change in intake of carbohydrates (servings/day)

    Using 4-day dietary record

    Measured: 12 weeks

  20. Change in intake of protein (servings/day)

    Using 4-day dietary record

    Measured: 12 weeks

  21. Change in intake of fruits (servings/day)

    Using 4-day dietary record

    Measured: 12 weeks

  22. Change in Intake of vegetables (servings/day)

    Using 4-day dietary record

    Measured: 12 weeks

  23. Change in intake of water in (litres/day)

    Using 4-day dietary record

    Measured: 12 weeks

  24. 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.

    Measured: 12 weeks

  25. 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.

    Measured: 12 weeks

  26. 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

    Measured: 12 weeks

  27. 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

    Measured: 12 weeks

  28. 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

    Measured: 12 weeks

  29. 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

    Measured: 12 weeks

  30. 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

    Measured: 12 weeks

  31. 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

    Measured: 12 weeks

  32. 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

    Measured: 12 weeks

  33. 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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2020
  2. Study start1 Oct 2017
  3. Primary completion27 Feb 2018
  4. Study completion27 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04217759
Sponsor's protocol ID
UBDIHS/13H0621
Status last verified
Jan 2020
First submitted
27 Dec 2019
Last updated
3 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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)

Questions about this trial

What is this clinical trial studying?

A study testing Healthy lifestyle intervention in people with Overweight and Obesity and Risk Reduction, run by Universiti Brunei Darussalam at 1 site in Brunei.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brunei. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in diabetes risk score from week 0 to week 13 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04217759.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.

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