NCT05736536

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

February 5, 2023

Last Update Submit

January 31, 2024

Conditions

ObesityDiabetes Mellitus, Type 2Behavior

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Changes of self-efficacy for weight loss (behaviour)

    T0 (Week 0), T1 (Week 5), T2 (Week 9)

  • Changes of decisional balance for weight loss (behaviour)

    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 body mass index (anthropometric)

    T0 (Week 0), T1 (Week 5), T2 (Week 9)

  • Changes waist circumference (anthropometric)

    T0 (Week 0), T1 (Week 5), T2 (Week 9)

  • +1 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Chance2ActBEHAVIORAL

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 Group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beserah Health Clinic

Kuantan, Pahang, 25000, Malaysia

Location

Paya Besar Health Clinic

Kuantan, Pahang, 25000, Malaysia

Location

Related Publications (1)

  • 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.

    PMID: 38294848DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 5, 2023

First Posted

February 21, 2023

Study Start

April 1, 2023

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

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

Locations

MY(2)