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IRCT201104106163N1 IRCT 2011-06-05 University Malaya A community-based healthy lifestyle intervention amongst high risk adults to prevent type 2 diabetes in Malaysia (Co-HELP)- a translational research Co-HELP A community-based healthy lifestyle intervention amongst high risk adults to prevent type 2 diabetes in Malaysia (Co-HELP)- a translational research 2011-09-01 anticipated 328 Complete https://irct.ir/trial/6600 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 1 type 2 diabetes. 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 intervention will focuses on empowerment of participants to change their lifestyle. This intervention will incorporates diet, physical activity and healthy behaviour modification. The contact schedule occurs in three phases, with an early 3- month intensive phase ( 1 group session every 2 weeks) followed by a 6-month non-intensive phase ( 1 group session every month) and a 3-month maintenance phase. The goals set for this intervention is based on what is outlined in the Clinical Practice Guidelines by Ministry of Health Malaysia, Management of type 2 Diabetes Mellitus, 4th edition 2009 to produce modest but yet achievable outcomes as below: • Reduction of 5-10% of initial body weight for all overweight and obese participants • Reduction of calorie intake (20-25 kcal/kg body weight) • Increase light to moderate physical activity to at least 150 minutes/ week The group will have series of different sessions with professionals like Physicians, Dietician/ Nutritionist and Physical trainer specialist during the intensive phase. Throughout the intervention, the participants will have a continuous support from Diabetic Educators (Nurses) and Peer Educators that acts as program facilitators. Facilitators will consult the professional health providers if any problems arise during the intervention sessions. Participants will also be referred to relevant health providers if the problem could not be handled by the program facilitators. i) 0 to 3rd month: Intensive intervention -2 weekly sessions for 3 months. Total 6 sessions, deliver by Professionals (Doctor, Nurse, Dietician, Sport Medicine Physician, Diabetic Educator or Community Health Nurse ii) 4th to 6 month: Non-intensive intervention-1 monthly sessions for 3 months. Total 3 sessions, deliver by Peer Educators with supervision by professionals. iii) 7th to 9th month: Non-intensive intervention- 1 monthly sessions for 3 months. Total 3 sessions, deliver by Peer Educators with supervision by professionals iv) 10th to 12th month: Maintenance of intervention- Follow up of participants by peer educators via phone, e-mail or home visits • Session with physician: To increase knowledge of the participants about the disease, sign and symptoms, common risk factors and complications associated with the disease. • Session with dietician or nutritionist: Not only focusing on food pyramid but also on healthy food choice. Might also conduct practical session on how to prepare healthy meals. • Session with sport medicine physician or physical trainer: Encourage participants to do light to moderate exercises at the beginning but later will encourage them to do moderate to high intensity exercises. The prescription is according to the participant’s age and health status. • Session with Diabetes Educators and Peer Educators: The session with Diabetes Educators and Peer Educators will be conducted on monthly basis with intention to ensure all participants are able to continue lifestyle modification activities that have been taught earlier. On the other hand this will also benefits the participating MDA’s members to continue and sustain the activities at their organization even after the study is over. The activities will be conducted in big group and small groups. For example; if the activity is in the form of one and half hour lecture, the participants will be grouped in large group of 50 people. But if the activities involve group-work or discussion, they will be grouped in smaller group of 10 to 15 people. Intervention 2: 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 subsequent blood taking visits.
public Dr Norliza binti Ibrahim
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Lembah Pantai
Kuala Lumpur Malaysia 59100 60-0379676657 drliza@siswa.um.edu.my Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya scientific Dr Moy Foong Ming
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Lembah Pantai
Kuala Lumpur Malaysia 59100 60-0379676657 moyfm@ummc.edu.my Department of Social and Preventive Medicine, University of Malaya Malaysia 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. 18 years 65 years Both E11.9 Non-insulin dependent Diabetes Mellittus without complications Lifestyle 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 will focuses on empowerment of participants to change their lifestyle. This intervention will incorporates diet, physical activity and healthy behaviour modification. The contact schedule occurs in three phases, with an early 3- month intensive phase ( 1 group session every 2 weeks) followed by a 6-month non-intensive phase ( 1 group session every month) and a 3-month maintenance phase. The goals set for this intervention is based on what is outlined in the Clinical Practice Guidelines by Ministry of Health Malaysia, Management of type 2 Diabetes Mellitus, 4th edition 2009 to produce modest but yet achievable outcomes as below: • Reduction of 5-10% of initial body weight for all overweight and obese participants • Reduction of calorie intake (20-25 kcal/kg body weight) • Increase light to moderate physical activity to at least 150 minutes/ week The group will have series of different sessions with professionals like Physicians, Dietician/ Nutritionist and Physical trainer specialist during the intensive phase. Throughout the intervention, the participants will have a continuous support from Diabetic Educators (Nurses) and Peer Educators that acts as program facilitators. Facilitators will consult the professional health providers if any problems arise during the intervention sessions. Participants will also be referred to relevant health providers if the problem could not be handled by the program facilitators. i) 0 to 3rd month: Intensive intervention -2 weekly sessions for 3 months. Total 6 sessions, deliver by Professionals (Doctor, Nurse, Dietician, Sport Medicine Physician, Diabetic Educator or Community Health Nurse ii) 4th to 6 month: Non-intensive intervention-1 monthly sessions for 3 months. Total 3 sessions, deliver by Peer Educators with supervision by professionals. iii) 7th to 9th month: Non-intensive intervention- 1 monthly sessions for 3 months. Total 3 sessions, deliver by Peer Educators with supervision by professionals iv) 10th to 12th month: Maintenance of intervention- Follow up of participants by peer educators via phone, e-mail or home visits • Session with physician: To increase knowledge of the participants about the disease, sign and symptoms, common risk factors and complications associated with the disease. • Session with dietician or nutritionist: Not only focusing on food pyramid but also on healthy food choice. Might also conduct practical session on how to prepare healthy meals. • Session with sport medicine physician or physical trainer: Encourage participants to do light to moderate exercises at the beginning but later will encourage them to do moderate to high intensity exercises. The prescription is according to the participant’s age and health status. • Session with Diabetes Educators and Peer Educators: The session with Diabetes Educators and Peer Educators will be conducted on monthly basis with intention to ensure all participants are able to continue lifestyle modification activities that have been taught earlier. On the other hand this will also benefits the participating MDA’s members to continue and sustain the activities at their organization even after the study is over. The activities will be conducted in big group and small groups. For example; if the activity is in the form of one and half hour lecture, the participants will be grouped in large group of 50 people. But if the activities involve group-work or discussion, they will be grouped in smaller group of 10 to 15 people. 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 subsequent blood taking visits. 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). 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). A community-based healthy lifestyle intervention amongst high risk adults to prevent type 2 diabetes Iranian Registry of Clinical Trials (IRCT) University Malaya Approved 2011-03-18 University Malaya Medical Centre (UMMC) Medical Ethics Committee UMMC, Lembah Pantai Kuala Lumpur Wilayah Persekutuan Kuala Lumpur Malaysia