Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT03997656
Eligibility Criteria:
Inclusion Criteria:
* aged 18-65 years old
* body mass index (BMI) of ≥23 kg/m2,
* high risk for diabetes (diabetes risk test score ≥5 \[22\] or HbA1c of 38-44 mmol/mol or 5.6-6.2%
* ownership of a smartphone (Android only) for communication defined as logging on at least once/day to the internet
* being fluent in Malay or English languages and
* had no contradictions to participate in weight management program or physical activity.
Exclusion Criteria:
* clinical history of diabetes or newly diagnosed diabetes at the time of screening where HbA1c level ≥45 mmol/mol or ≥6.3%
* taking oral anti-diabetic agents
* participating in a concurrent weight management program or interventional research protocol
* on a prescribed medical diet, anti-obesity or diabetes therapy within the preceding 4 months
* had clinical history of cardiovascular diseases occurred within the past 6 months
* any form of cancers that require treatment
* dementia or probable Alzheimer's disease
* advanced arthritis
* pregnant or within 6 weeks of having given birth or planning to become pregnant in the next 12 months
* existing liver and renal disease and having hyperthyroidism
* any mental health condition including eating disorder or alcohol/substance use
* other causes which could interfere with participation (for examples physically disabled)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03997656
Study Brief:
Protocol Section:
NCT03997656