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

Not Applicable

Completed

• Conditions: Obesity; Diabetes Mellitus, Type 2; Behavior
• Interventions: Behavioral: Chance2Act

• Registration Number: NCT05736536
• Lead Sponsor: Universiti Teknologi Mara

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-05
• Study First Submitted QC: 2023-02-05
• Study First Posted: 2023-02-21
• Study Start: 2023-04-01
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Chance2Act	This group will receive a package of health education modules through Chance2Act website in addition to the existing health education being offered in the health clinic.

Primary Outcome Measures

Name	Time	Method
Changes of readiness to change for weight loss (behaviour)	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 Outcome Measures

Name	Time	Method
Changes of decisional balance for weight loss (behaviour)	T0 (Week 0), T1 (Week 5), T2 (Week 9)	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
Changes waist circumference (anthropometric)	T0 (Week 0), T1 (Week 5), T2 (Week 9)	The changes waist circumference measurement
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)	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
Changes in body fat composition (anthropometric)	T0 (Week 0), T1 (Week 5), T2 (Week 9)	The changes in body fat composition (total and visceral fat)
Changes of self-efficacy for weight loss (behaviour)	T0 (Week 0), T1 (Week 5), T2 (Week 9)	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
Changes body mass index (anthropometric)	T0 (Week 0), T1 (Week 5), T2 (Week 9)	The changes body mass index measurement

Trial Locations

Locations (2)

Paya Besar Health Clinic; 🇲🇾 Kuantan, Pahang, Malaysia

Beserah Health Clinic; 🇲🇾 Kuantan, Pahang, Malaysia