PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Fri, 01 Oct 2021 02:38:43 GMT) CTRI Number CTRI/2018/04/013506 [Registered on: 26/04/2018] - Trial Registered Retrospectively Last Modified On 21/04/2018 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Preventive Study Design Randomized, Parallel Group, Placebo Controlled Trial Public Title of Study A STUDY TO EVALUATE THE EFFECTIVENESS OF A STRUCTURED TEACHING PROGRAM ON KNOWLEDGE AND PRACTICE REGARDING PREVENTION OF TYPE 2 DIABETES MELLITUS AMONG ADOLESCENTS IN SELECTED SCHOOLS OF KERALA Scientific Title of Effectiveness of a structured teaching program on knowledge and practice regarding prevention of Study type 2 diabetes mellitus among adolescents in selected schools of Kerala Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr THEYAMMA JOSEPH Trial Coordinator (multi-center study) Designation PRINCIPAL Affiliation MAR SLEEVA COLLEGE OF NURSING Address THEYAMMA JOSEPH MAR SLEEVA COLLEGE OF NURSING PALAI CHERPUNKAL P O KOTTAYAM DISTRICT KERALA INDIA MAR SLEEVA COLLEGE OF NURSING PALAI CHERPUNKAL P O KOTTAYAM DISTRICT KERALA INDIA Kottayam KERALA 686584 India Phone 9495023393 Fax 04822256518 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr ASSUMA BEEVI T M Query) Designation PRINCIPAL Affiliation MIMS COLLEGE OF NURSING Address MIMS COLLEGE OF NURSING VADAKEDATHPARAMBA PUTHUKODE P.O. VAZHAYUR NEAR RAMANATTUKARA MALAPPURAM DISTRICT KERALA INDIA MIMS COLLEGE OF NURSING VADAKEDATHPARAMBA PUTHUKODE P.O. VAZHAYUR NEAR RAMANATTUKARA MALAPPURAM DISTRICT KERALA INDIA Malappuram KERALA 673633 India Phone 04832833032 Fax 04832832992 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr THEYAMMA jOSEPH Designation PRINCIPAL Affiliation MAR SLEEVA COLLEGE OF NURSING page 1 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Address THEYAMMA JOSEPH MAR SLEEVA COLLEGE OF NURSING PALAI CHERPUNKAL P O KOTTAYAM DISTRICT KERALA INDIA MAR SLEEVA COLLEGE OF NURSING PALAI CHERPUNKAL P O KOTTAYAM DISTRICT KERALA INDIA Kottayam KERALA 686584 India Phone 9495023393 Fax 04822256518 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Mar Baselios College of Nursing Primary Sponsor Primary Sponsor Details Name THEYAMMA jOSEPH Address THEYAMMA JOSEPH MAR SLEEVA COLLEGE FO NURSING PALAI CHERPUNKAL PO KOTTAYAM DISTRICT KERALA 686 584 Type of Sponsor Other [Nil] Details of Secondary Name Address Sponsor Dr ASSUMA BEEVI T M MIMS COLLEGE OF NURSING VADAKEDTHPARAMBA PUTHUKODE P O VAZHAYUR NEAR RAMANATTUKARA MALAPPURAM DISTRICT KERALA PIN-673633 Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr THEYAMMA De Paul Public School De Paul Public School 9495023393 JOSEPH Thodupuzha 04822256518 Idukki theyamma.joseph@gm KERALA ail.com Dr THEYAMMA Devaswam Board High Devaswam Board High 9495023393 JOSEPH School School Thrikkariyoor 04822256518 Ernakulam theyamma.joseph@gm KERALA ail.com Dr THEYAMMA Govt. HS School Govt. HS School 9495023393 JOSEPH Muttom 04822256518 Idukki theyamma.joseph@gm KERALA ail.com Dr THEYAMMA Govt. VHSS Govt. VHSS 9495023393 JOSEPH Pallarimangalam 04822256518 Ernakulam theyamma.joseph@gm KERALA ail.com Dr THEYAMMA Malik Deenar Public Malik Deenar Public 9495023393 JOSEPH School School Adivadu 04822256518 Pallarimangalam theyamma.joseph@gm Ernakulam ail.com KERALA Dr THEYAMMA Mar Elias, HSS Mar Elias, HSS 9495023393 JOSEPH Kottappady 04822256518 Ernakulam theyamma.joseph@gm KERALA ail.com Dr THEYAMMA Martha Mariam School Martha Mariam School 9495023393 JOSEPH Kozhipilly 04822256518 page 2 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Kothamangalam theyamma.joseph@gm Ernakulam ail.com KERALA Dr THEYAMMA Nirmala Public School Nirmala Public School 9495023393 JOSEPH Karimannoor 04822256518 Idukki theyamma.joseph@gm KERALA ail.com Dr THEYAMMA St Georges HS St Georges HS 9495023393 JOSEPH Kothamangalam 04822256518 Ernakulam theyamma.joseph@gm KERALA ail.com Dr THEYAMMA St Georges HS St Georges HS 9495023393 JOSEPH Kalayanthani 04822256518 Idukki theyamma.joseph@gm KERALA ail.com Dr THEYAMMA St Josephs HSS St Josephs HSS 9495023393 JOSEPH Karimannoor 04822256518 Idukki theyamma.joseph@gm KERALA ail.com Dr THEYAMMA St Marys Public School St Marys Public School 9495023393 JOSEPH Karukadam 04822256518 Ernakulam theyamma.joseph@gm KERALA ail.com Dr THEYAMMA St. Augustine GH St. Augustine GH 9495023393 JOSEPH Kothamangalam 04822256518 Ernakulam theyamma.joseph@gm KERALA ail.com Dr THEYAMMA St. Sebastians High St. Sebastians High 9495023393 JOSEPH School School Thodupuzha 04822256518 Idukki theyamma.joseph@gm KERALA ail.com Dr THEYAMMA Vimala Giri Public Vimala Giri Public 9495023393 JOSEPH School School Kothamangalam 04822256518 Ernakulam theyamma.joseph@gm KERALA ail.com Dr THEYAMMA Vimala Public School Vimala Public School 9495023393 JOSEPH Thodupuzha 04822256518 Idukki theyamma.joseph@gm KERALA ail.com Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Review Approved 17/10/2013 No Board Government Medical College Thrissur Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers Age between 13 to 15 years. Studying in IX Standard of the selected schools. Able to read and write Malayalam or English. Willing to participate in the study. Not having Diabetes Mellitus Intervention / Type Name Details Comparator Agent Intervention 1. Structured Teaching A structured teaching program page 3 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Program(STP) on Type 2 (STP) on prevention of T2DM Diabetes Mellitus(T2DM) 2. contained information on Booklet on T2DM Diabetes Mellitus, types, causes, risk factors, clinical manifestations, management, potential complications and preventive measures, including healthy lifestyle practices. The STP was developed, validated and administered to the experimental group in groups of 30-40 each. Teaching was augmented with a booklet on T2DM in local language (Malayalam) as handout to reinforce the lesson and spread the message to their families and neighborhood. Comparator Agent NIL NIL Inclusion Criteria Inclusion Criteria Age From 13.00 Year(s) Age To 15.00 Year(s) Gender Both Details Adolescents <br/> Age between 13 to 15 years<br/> Studying in IX Standard of the selected schools<br/> Able to read and write Malayalam or English<br/> Willing to participate in the study <br/> Have no Diabetes Mellitus<br/> Exclusion Criteria Exclusion Criteria Details Adolescents: Studying in class other than IX standard Suffering from Type 1 or 2 Diabetes Mellitus Not willing to participate in the study Method of Generating Other Random Sequence Method of Centralized Concealment Blinding/Masking Participant Blinded Primary Outcome Outcome Timepoints Gain in knowledge scores and change in lifestyle 1 month including food habits and activity patterns Secondary Outcome Outcome Timepoints Change over to healthy lifestyle in order to Prevent or delay the early development of T2DM prevent the early development of modifiable risk among the population factors for T2DM among adolescents Target Sample Size Total Sample Size=975 Sample Size from India=975 Final Enrollment numbers achieved (Total)=975 Final Enrollment numbers achieved (India)=975 Phase of Trial N/A Date of First 15/06/2014 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 page 4 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Trial Months=7 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details Joseph T, Beevi A. Effectiveness of a Structured Teaching Program on Knowledge and Practice Regarding Prevention of Type 2 Diabetes Mellitus among Adolescents in Selected Schools of Kerala, India. International Journal of Innovative Research Development 2016 Nov; 5(13) p.156-64. ISSN 2278 –0211 (Online) Available from: http://www. ijird.com /index.php/ijird/article/view/106690 Brief Summary The study primarily intended to study whether type 2 DM can be prevented or delayed in the public population by taking a proactive step like motivating the adolescents to adopt a healthy lifestyle by educating them about T2DM, its risk factors, signs and symptoms, management, complications and possible prevention by adopting a healthy lifestyle. This was a randomized, controlled, parallel group, multicenter trial comparing the effectiveness of an educational intervention related to prevention of Type 2 Diabetes Mellitus among 975 healthy adolescent subjects of both genders who have no Diabetes Mellitus at the time of study. The study was conducted among all students studying in IXth standard of 18 selected schools from urban and rural areas of two educational districts of central Kerala state of India. The variables knowledge about T2DM and the prevailing lifestyle was measured using reliability tested validated questionnaire and a lifestyle practice inventory in both groups (pretest). The educational intervention was administered to the experimental group alone after the pretest. The primary outcome variable