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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05736536
Acronym
BMI
Enrollment
104
Registered
2023-02-21
Start date
2023-04-01
Completion date
2023-12-15
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Diabetes Mellitus, Type 2, Obesity

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?

Interventions

BEHAVIORALChance2Act

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.

Sponsors

Universiti Teknologi Mara
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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 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 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 waist circumference (anthropometric)T0 (Week 0), T1 (Week 5), T2 (Week 9)The changes waist circumference measurement
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 body mass index (anthropometric)T0 (Week 0), T1 (Week 5), T2 (Week 9)The changes body mass index measurement

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026