Behavior Intervention for Weight Loss for Type 2 Diabetes Mellitus Adults With Obesity Problem (BMI of ≥23kg/m2)

Obesity Clinical Trial

— BMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05736536
• Other study ID #: UiTMara Chance2Act
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: Universiti Teknologi Mara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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/m2.

• 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.

Related Conditions & MeSH terms

• Behavior
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Behavioral:
• Chance2Act
A Health education package that has been developed based on Transtheoretical Model to encourage behaviour change for weight loss among overweight/obese type 2 diabetes adults.

Locations

Country	Name	City	State
Malaysia	Beserah Health Clinic	Kuantan	Pahang
Malaysia	Paya Besar Health Clinic	Kuantan	Pahang

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Teknologi Mara

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of readiness to change for weight loss (behaviour)	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)	T0 (Week 0), T1 (Week 5), T2 (Week 9)
Secondary	Changes of self-efficacy for weight loss (behaviour)	The changes for self-efficacy to control eating impulses based on Weight Efficacy Lifestyle Questionnaire (Transtheoretical Model).; Domains (4 items in each domain); Negative emotions; Availability; Social Pressure; Physical discomfort; Positive Activities; Data type: Numerical data. A higher score shows better outcomes. Rating of each item: 0 - 9; Lowest score: 0 in each subscale Highest score: 36 in each subscale	T0 (Week 0), T1 (Week 5), T2 (Week 9)
Secondary	Changes of decisional balance for weight loss (behaviour)	The changes for decisional balance to decide on the pros and cons of weight loss based on the Decisional Questionnaire Inventory questionnaire (Transtheoretical Model).; Domains (10 items in each domain); Pro scale (Measure the positive effects from weight loss. A higher score shows better outcomes); Con scale (Measure the negative effects from weight loss. A higher score shows worse outcomes); Rating of each item: 1 - 5; Data type: Numerical data.; Lowest score: 10 in each subscale Highest score: 50 in each subscale	T0 (Week 0), T1 (Week 5), T2 (Week 9)
Secondary	Changes in family support for healthy diet and physical activity to encourage weight loss (social support)	The changes for social support for weight loss based on the Social Support Scale for Diet and Exercise; Domains: Family support for physical activity (12 items); Family encouragement for healthy diet (5 items); Family discouragement for healthy diet (5 items); Rating for each item: 1 - 5; Data type: Numerical data.; Total subscale score: Family support for physical activity: 12 - 60: A higher score shows better outcomes.; Family encouragement for healthy eating 5 - 25: A higher score shows better outcomes.; Family discouragement for healthy eating 5 - 25: A higher score shows worse outcomes	T0 (Week 0), T1 (Week 5), T2 (Week 9)
Secondary	Changes body mass index (anthropometric)	The changes body mass index measurement	T0 (Week 0), T1 (Week 5), T2 (Week 9)
Secondary	Changes waist circumference (anthropometric)	The changes waist circumference measurement	T0 (Week 0), T1 (Week 5), T2 (Week 9)
Secondary	Changes in body fat composition (anthropometric)	The changes in body fat composition (total and visceral fat)	T0 (Week 0), T1 (Week 5), T2 (Week 9)