ObesityBMINCT05736536
Behavior Intervention for Weight Loss for Type 2 Diabetes Mellitus Adults With Obesity Problem (BMI of ≥23kg/m2)
A study testing Chance2Act in people with Obesity and Diabetes Mellitus, Type 2, run by Universiti Teknologi Mara at 2 sites in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2, Behavior
- What is being tested?
- Chance2Act
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesMalaysia
- Study dates
- 1 Apr 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites
Beserah Health Clinic
Kuantan, Pahang, 25000
Paya Besar Health Clinic
Kuantan, Pahang, 25000
About this study
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
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?
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Behavior
- Being tested
- Chance2Act
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chance2ActBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Chance2Act |
| Control Group | No intervention | This group will receive the existing health education being offered in the health clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: T0 (Week 0), T1 (Week 5), T2 (Week 9)
Secondary outcomes (6)
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
Measured: T0 (Week 0), T1 (Week 5), T2 (Week 9)
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
Measured: 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)
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
Measured: T0 (Week 0), T1 (Week 5), T2 (Week 9)
Changes body mass index (anthropometric)
The changes body mass index measurement
Measured: T0 (Week 0), T1 (Week 5), T2 (Week 9)
Changes waist circumference (anthropometric)
The changes waist circumference measurement
Measured: T0 (Week 0), T1 (Week 5), T2 (Week 9)
Changes in body fat composition (anthropometric)
The changes in body fat composition (total and visceral fat)
Measured: T0 (Week 0), T1 (Week 5), T2 (Week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Apr 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noraini Binti Mohd Saad, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736536
- Sponsor's protocol ID
- UiTMara Chance2Act
- Acronym
- BMI
- Status last verified
- Jan 2024
- First submitted
- 5 Feb 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 38294848
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05736536
- Acronym / sponsor ID
- BMI / UiTMara Chance2Act
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Chance2ActThis 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. |
| Control Group | No intervention | –This group will receive the existing health education being offered in the health clinic. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chance2ActA 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. | Behavioural | Intervention Group |
Primary outcome
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)
6 secondary outcomes
Changes of self-efficacy for weight loss (behaviour)
Time frame: 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)
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)
Changes body mass index (anthropometric)
Time frame: T0 (Week 0), T1 (Week 5), T2 (Week 9)
Changes waist circumference (anthropometric)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Derived from this study: PubMed 38294848Mohd 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.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chance2Act in people with Obesity and Diabetes Mellitus, Type 2, run by Universiti Teknologi Mara at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of readiness to change for weight loss (behaviour) (time frame: T0 (Week 0), T1 (Week 5), T2 (Week 9)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05736536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.