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

January 31, 2024 updated by: Noraini Binti Mohd Saad, Universiti Teknologi Mara

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Pahang
      • Kuantan, Pahang, Malaysia, 25000
        • Beserah Health Clinic
      • Kuantan, Pahang, Malaysia, 25000
        • Paya Besar Health Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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.
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.
No Intervention: Control Group
This group will receive the existing health education being offered in the health clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
T0 (Week 0), T1 (Week 5), T2 (Week 9)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Teknologi Mara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

February 5, 2023

First Submitted That Met QC Criteria

February 5, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UiTMara Chance2Act

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data collected in the study will not be shared with other researchers to protect the confidentiality of patients' information as requested by the study site's authorized organization.

The study IPD includes:

  1. Study Protocol
  2. Statistical Analysis Plan
  3. Informed Consent Form
  4. Clinical Study Report
  5. Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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