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

Phase 1

• Conditions: type 2 diabetes.; Non-insulin dependent Diabetes Mellittus without complications

• Registration Number: IRCT201104106163N1
• Lead Sponsor: niversity Malaya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 328

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).