Skip to main content
Clinical Trials/NCT05736536
NCT05736536
Completed
Not Applicable

Health Intervention on Behaviour Change to Act for Adults With Type 2 Diabetes Mellitus and Body Mass Index of ≥ 23kg/m2: a Quasi-Experimental Study

Universiti Teknologi Mara2 sites in 1 country104 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Universiti Teknologi Mara
Enrollment
104
Locations
2
Primary Endpoint
Changes of readiness to change for weight loss (behaviour)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This quasi-experimental study aims to determine the effectiveness of a health intervention (Chance2Act) on behaviour change to act for weight loss among overweight/obese type 2 diabetes adults.

The main question it aims to answer is:

  • Is the new health intervention (Chance2Act) effective in changing overweight/obese type 2 diabetes adults from not being ready to act, to take action to lose weight?
Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
December 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Noraini Binti Mohd Saad

Principal Investigator

Universiti Teknologi Mara

Eligibility Criteria

Inclusion Criteria

  • T2DM patients under follow-up of government health clinics Kuantan, Pahang.
  • Age between 20 - 65 years old.
  • Body Mass Index of more or equal to 23 kg/m
  • In the stage of pre-contemplation, contemplation, or preparation stage of change based on the S-weights questionnaire.
  • Able to understand, read and write in the Malay Language.
  • Have access to smartphone devices and internet services.
  • Have immediate family members (adults) who are living in the same household.

Exclusion Criteria

  • Pregnant patients.
  • Patients' advanced comorbidity that will affect participation in the study protocol (e.g. vision problem, unable to walk or physically unfit to stand up, advanced heart failure, or cancer).
  • Patients with mental conditions which will affect understanding of the study protocol.

Outcomes

Primary Outcomes

Changes of readiness to change for weight loss (behaviour)

Time Frame: T0 (Week 0), T1 (Week 5), T2 (Week 9)

The stage of change for weight loss is based on the S-weight questionnaire (Transtheoretical Model). Data type: Categorical data (either in pre-contemplation, contemplation, preparation, or action stage)

Secondary Outcomes

  • Changes of decisional balance for weight loss (behaviour)(T0 (Week 0), T1 (Week 5), T2 (Week 9))
  • Changes waist circumference (anthropometric)(T0 (Week 0), T1 (Week 5), T2 (Week 9))
  • Changes in family support for healthy diet and physical activity to encourage weight loss (social support)(T0 (Week 0), T1 (Week 5), T2 (Week 9))
  • Changes of self-efficacy for weight loss (behaviour)(T0 (Week 0), T1 (Week 5), T2 (Week 9))
  • Changes body mass index (anthropometric)(T0 (Week 0), T1 (Week 5), T2 (Week 9))
  • Changes in body fat composition (anthropometric)(T0 (Week 0), T1 (Week 5), T2 (Week 9))

Study Sites (2)

Loading locations...

Similar Trials