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

NCT ID: NCT05736536

Last Updated: 2024-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Diabetes Mellitus, Type 2 Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Chance2Act

Intervention Type BEHAVIORAL

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.

Control Group

This group will receive the existing health education being offered in the health clinic.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universiti Teknologi Mara

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Noraini Binti Mohd Saad

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beserah Health Clinic

Kuantan, Pahang, Malaysia

Site Status

Paya Besar Health Clinic

Kuantan, Pahang, Malaysia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Malaysia

References

Explore related publications, articles, or registry entries linked to this study.

Mohd Saad N, Mohamad M, Mat Ruzlin AN. Web-Based Intervention to Act for Weight Loss in Adults With Type 2 Diabetes With Obesity (Chance2Act): Protocol for a Nonrandomized Controlled Trial. JMIR Res Protoc. 2024 Jan 31;13:e48313. doi: 10.2196/48313.

Reference Type DERIVED
PMID: 38294848 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UiTMara Chance2Act

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Journey to Better Health
NCT02938312 COMPLETED NA
The Women's Healthy Lifestyle Study
NCT00583726 COMPLETED NA