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A community-based healthy lifestyle intervention amongst high risk adults to prevent type 2 diabetes in Malaysia (Co-HELP)- a translational research

A community-based healthy lifestyle intervention amongst high risk adults to prevent type 2 diabetes in Malaysia (Co-HELP)- a translational research

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT201104106163N1
Enrollment
328
Registered
2011-06-05
Start date
2011-09-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

type 2 diabetes. Non-insulin dependent Diabetes Mellittus without complications

Interventions

Intervention 1: A) Lifestyle modification intervention group The lifestyle modification intervention sessions will be conducted in group format, coordinated and facilitated by the peer educators. The
Lifestyle
A) Lifestyle modification intervention group The lifestyle modification intervention sessions will be conducted in group format, coordinated and facilitated by the peer educators. The intervention wi
B) Conventional intervention group : Participants in the conventional intervention group will receive general verbal and written information about diet and exercise during baseline investigation and

Sponsors

University Malaya
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: a)Inclusion criteria : -Adults of high risk groups age between 18 to 65 years old, Malaysian nationality -Able to read and write in Bahasa Malaysia or English language -Willing to give written consent and participate voluntarily has Impaired fasting glucose (IFG) between 5.6 to 6.9 mmol/L (100-125 mg/dL) and /or Impaired Glucose Tolerance (IGT) between 7.8 to 11.0 mmol/L (140-199 mg/dL) -Overweight (BMI> 23 kg/m²) with other risk factors like Waist Circumference (WC) > 80 cm in women and > 90 cm in men, history of diabetes in family members, presence of hypertension or dyslipidemia or physically inactive b)Exclusion criteria: -Not willing to give written consent and participate voluntarily or not interested to continue follow up -Has been diagnosed with Diabetes Mellitus -Has fasting plasma glucose =7.0 mmol/L(=126 mg/dL). They will be referred immediately to the health care provider for confirmation of established Diabetes Mellitus during the screening process. -Has been diagnosed with other pre-existing co-morbidities that are contraindicated to adopt light to moderate physical activity (e.g; a recent cardiovascular event including myocardial infarction, angina, stroke, TIA, peripheral vascular disease, congestive heart failure, carotid and coronary vascularizations, severe chronic obstructive pulmonary disease, advanced arthritis, poorly controlled hypertension , any form of cancers that limit lifespan to less than 3 years and require treatment) -Pregnant, psychological disorder or physically disabled which can interfere with participation.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Changes in blood glucose. Timepoint: Baseline,3 months, 6 months, 9 months,12 months. Method of measurement: Fasting bloood glucose (mmol/L), HbA1C (mmol/L).

Secondary

MeasureTime frame
Changes in weight. Timepoint: Baseline, 3 months, 6 months, 9 months , 12 months. Method of measurement: Weight (kg).;Changes in BMI. Timepoint: baseline, 3rd, 6th, 9th and 12th mth. Method of measurement: BMI (kg/m2).;Changes in waist circumference. Timepoint: baseline, 3rd, 6th, 9th and 12th mth. Method of measurement: Waist circumference (cm).;Changes in total cholesterol. Timepoint: baseline, 3rd, 6th, 9th and 12 mth. Method of measurement: Total cholesterol (mmol/L).;Changes in HDL. Timepoint: baseline, 3rd, 6th, 9th and 12th mth. Method of measurement: HDL (mmol/L).;Changes in Triglycerides. Timepoint: baseline, 3rd, 6th, 9th and 12th mth. Method of measurement: TG (mmol/L).;Changes in Blood pressure. Timepoint: baseline, 3rd, 6th, 9th and 12th mth. Method of measurement: BP (mm Hg).

Countries

Malaysia

Contacts

Public ContactDr Norliza binti Ibrahim

Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya

drliza@siswa.um.edu.my60-0379676657

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 28, 2026