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Completed

NCT Number: NCT04217759

Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults

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.

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Key information

Conditions

Overweight and Obesity Behavior Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Risk Reduction Risk Reduction Behavior Signs and Symptoms

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PAPRSB Institute of Health Sciences, Universiti Brunei Darussalam

Brunei, Bandar Seri Begawan, BE1410

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy lifestyle intervention

Behavioral

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 names: Be Healthy Camp

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universiti Brunei Darussalam

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 3, 2020
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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