Healthy Lifestyle Intervention on Diabetes Risk Reduction Among Bruneian Young Adults

NCT04217759 | Completed

• 1 other identifier: UBDIHS/13H0621
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

social cognitive theory; Type 2 diabetes mellitus; social media; diabetes prevention; lifestyle intervention

Outcome Measures

Primary Outcomes (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.

  12 weeks

Secondary Outcomes (33)

• Change in weight (kg)

  12 weeks

• Change in weight (%)

  12 weeks

• Height in cm

  At baseline

• Change in body mass index (BMI) (kg/m2)

  12 weeks

• Change in waist circumference (WC) (cm)

  12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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.

Also known as: Be Healthy Camp

Intervention group

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Universiti Brunei Darussalam: lead

Study Sites (1)

PAPRSB Institute of Health Sciences, Universiti Brunei Darussalam

Brunei, Bandar Seri Begawan, BE1410, Brunei

Location

MeSH Terms

Conditions

Overweight; Obesity; Risk Reduction Behavior; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alifah Nur'ain Haji Mat Rasil

  University Brunei Darussalam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 3, 2020
• Study Start: October 1, 2017
• Primary Completion: February 27, 2018
• Study Completion: February 27, 2018
• Last Updated: January 3, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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)

Locations

BR (1)