Although an intensive lifestyle intervention has been demonstrated to reduce the development of type 2 diabetes in high-risk individuals, it has yet to be widely adopted at the community level. There is little information about the feasibility of offering such intervention in community settings. This study is designed to translate the diabetes prevention approach for use in the community settings as an intervention administered through the Malaysia Diabetes Association (MDA), a local Non-Governmental Organization (NGO). This is a quasi-experimental study that will assess the effectiveness of lifestyle modification intervention as compared to the usual care in reducing the modifiable risk factors of type 2 diabetes in high risk adults. The population of this study is the adults with pre-diabetes status that will be recruited through the community-based screening events within the Ampangan and Senawang localities. The strategy of intervention is by using group-based approach, collaborative efforts between professionals and community volunteers as the facilitators. The general objective of this study is to assess the effectiveness of lifestyle modification intervention as compared to usual care in reducing the modifiable risk factors of type 2 diabetes in high risk adults. The primary outcome measure is change in fasting blood glucose, 2HPP and HbA1C. Whereas, the secondary outcomes include the cardiovascular risk factors, change in dietary intake, physical activity and health-related quality of life. The outcomes will be analyzed at regular intervals within a period of 6 months. The finding from this study will perhaps demonstrate that a community-based lifestyle intervention administered through partnership with a local Non-Governmental Organization such as Malaysia Diabetes Association may become a promising strategy for widespread dissemination of interventions at preventing type 2 diabetes in high risk individuals in Malaysia.
General information
Acronym
Co-HELP
IRCT registration information
IRCT registration number:IRCT201104106163N1
Registration date:2011-06-05, 1390/03/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-06-05, 1390/03/15
Registrant information
Name
Norliza Ibrahim
Name of organization / entity
University of Malaya
Country
Malaysia
Phone
60-03-79676657
Email address
drliza@siswa.um.edu.my
Recruitment status
Recruitment complete
Funding source
POST GRADUATE RESEARCH GRANT FROM UNIVERSITY OF MALAYA, MALAYSIA
Expected recruitment start date
2011-09-01, 1390/06/10
Expected recruitment end date
2012-08-31, 1391/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A community-based healthy lifestyle intervention amongst high risk adults to prevent type 2 diabetes in Malaysia (Co-HELP)- a translational research
Public title
A community-based healthy lifestyle intervention amongst high risk adults to prevent type 2 diabetes in Malaysia (Co-HELP)- a translational research
Purpose
Prevention
Inclusion/Exclusion 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.
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
328
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Iranian Registry of Clinical Trials (IRCT)
Secondary trial Id
A community-based healthy lifestyle intervention amongst high risk adults to prevent type 2 diabetes
Registration date
2017-05-11, 1396/02/21
Ethics committees
1
Ethics committee
Name of ethics committee
University Malaya Medical Centre (UMMC) Medical Ethics Committee
Street address
UMMC, Lembah Pantai
City
Kuala Lumpur
Postal code
59100
Approval date
2011-03-18, 1389/12/27
Ethics committee reference number
841.3
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E11.9
ICD-10 code description
Non-insulin dependent Diabetes Mellittus without complications
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.
Category
Lifestyle
2
Description
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.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Malaysian Diabetes Association
Full name of responsible person
Professor Dato Dr Ikram Shah bin Ismail
Street address
Malaysian Diabetes Association, No 2 Lorong 11/4E
City
Petaling Jaya
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University Malaya
Full name of responsible person
Dr Moy Foong Ming
Street address
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya
City
Kuala Lumpur
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University Malaya
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya
Full name of responsible person
Dr Norliza binti Ibrahim
Position
MPH, DrPH candidate, Principal investigator for this research
Other areas of specialty/work
Street address
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Lembah Pantai
City
Kuala Lumpur
Province
Wilayah Persekutuan Kuala Lumpur
Postal code
59100
Phone
60-0379676657
Fax
60-0379674975
Email
drliza@siswa.um.edu.my
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Social and Preventive Medicine, University of Malaya
Full name of responsible person
Dr Moy Foong Ming
Position
Senior Lecturer
Other areas of specialty/work
Street address
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Lembah Pantai
City
Kuala Lumpur
Province
Wilayah Persekutuan Kuala Lumpur
Postal code
59100
Phone
60-0379676657
Fax
60-0379674975
Email
moyfm@ummc.edu.my
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya
Full name of responsible person
Dr Norliza binti Ibrahim
Position
MPH, DrPH candidate, Principal investigator for this research
Other areas of specialty/work
Street address
Department of Social and Preventive Medicine, University of Malaya, Lembah Pantai
City
Kuala Lumpur
Province
Wilayah Persekutuan Kuala Lumpur
Postal code
59100
Phone
60-0379676657
Fax
60-0379674975
Email
drliza@siswa.um.edu.my
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)