Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201910518676391 Date of Approval: 08/10/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Nutrition Education Programme and its Effect on Type 2 Diabetes Attending Care at Thika Level 5 Hospital
Official scientific title Effect of Nutrition Education Programme on Metabolic Syndrome, Adherence to Lifestyle Modification and Health Care Cost Incurred by Patients with Type 2 Diabetes Attending Care at Thika Level 5 Hospital in Kenya
Brief summary describing the background and objectives of the trial Type 2 Diabetes mellitus is a major global public health concern (IDF; International DiabetesFederation, 2017; The International Diabetes Federation (IDF), 2015; WHO; World Health Organization, 2016, 2017). In 2016, there were 415 million people affected while in 2017 there were425 million people were affected (IDF; International DiabetesFederation, 2017; The International Diabetes Federation (IDF), 2015). It is projected that by 2045, there will be 629 million people living with Diabetes (IDF; International DiabetesFederation, 2017) Statistics have also shown that 80% of the people with Type 2 Diabetes come from low and middle income countries (IDF; International DiabetesFederation, 2017; WHO; World Health Organization, 2016, 2017)Diabetes is a threat to national development as it often results in longstanding complications like blindness, renal failure and lower limb amputation that are usually very costly to treat(IDF; International DiabetesFederation, 2017; WHO; World Health Organization, 2016). In addition, a high percentage of undiagnosed diabetes ends up in irreversible medical conditions thus posing a bigger challenge to this burden(IDF; International DiabetesFederation, 2017). Several modifiable factors that are risk factors to diabetes include obesity/overweight, consumption of refined carbohydrates, consumption of high fat diets and lack of physical activity due to sedentary lifestyle (Chiu & Wray, 2010; Hu, Hori, Nishiura, Sasaki, & Okazaki, 2016; IDF; International DiabetesFederation, 2017; Little, Humphries, Patel, & Dewey, 2016; Tadewos, Egeno, & Amsalu, 2017)These risk factors are also related to metabolic syndrome; a cluster of interrelated clinical factors that include insulin resistance, dyslipidemia, excess weight and elevated blood pressure(Alberti K.G.M.M. et al., 2009)Metabolic syndrome is associated with a threefold increase in Type 2-diabetes and a two fold increase in cardiovascular diseases (Alberti K.G.M.M. et al., 2009; Kaur, 2014)In addition, lack of adherence by patient to diet, physical activity and other lifestyle conditions as well as reaction to drugs aggravate the condition (Alefishat & Farha, 2017; Ganiyu, Mabuza, Malete, Govender, & Ogunbanjo, 2013; Mukonka, Mukona, Zvinavashe, Augustine, & Maxwell, 2016; Musee, Omondi, & Odiwuor, 2016; Riaz, Basit, Fawwad, Ahmedani, & Riizv, 2014)). Coordinated interventions that encourage individuals to maintain healthy weight, have good controlled glucose level and participate in physical activity can reduce the negative effects of Diabetes as well as metabolic syndrome (Anderson et al., 2015; Askari, Rabiei, & Rastmanesh, 2013; A. M. et al., 2013; Makrilakis et al., 2012; Mohamed, 2014; Muchiri, Gericke, & Rheeder, 2015; Soósová & Hrehová, 2014; Yamaoka & Tango, 2012). This study aim was to test the effectiveness of a nutrition education programme on nutrition and physical activity knowledge, metabolic syndrome, adherence to lifestyle changes and health care cost incurred by Type 2 Diabetes patient’s mellitus. This was a randomized controlled trial with two intervention groups and one control.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NEP
Disease(s) or condition(s) being studied Circulatory System,Nutritional, Metabolic, Endocrine,Type 2 diabetes mellitus
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/08/2016
Actual trial start date 01/08/2016
Anticipated date of last follow up 30/06/2017
Actual Last follow-up date 30/06/2017
Anticipated target sample size (number of participants) 153
Actual target sample size (number of participants) 153
Recruitment status Completed
Publication URL Not Applicable
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nutrition Education Programme and its Effect on Type 2 Diabetes Attending Care at Thika Level 5 Hos 8 weeks 2 hours nutrition education with physical activity 2 hours for eight week and followup six months The curriculum focused on nutrition in relation to diabetes, food portion control for weight reduction, use of healthier food choices, an individualized meal planning; glycemic index and glycemic load of different food and there importance in blood glucose control; food pyramid and its use together with food exchange list Patient learnt about the basics food groups, the difference between simple and complex carbohydrates and their relation to glycemic index and glycemic load, fibre content of different cereals and starches, the difference between saturated and unsaturated fats and their relation to diabetes management; sources of protein and the different nutrient content of each; hidden calories contained in beverages; and the micronutrient and fiber values of fruits and vegetables. The nutrition content was presented using lectures, demonstration, discussion, and other participatory method. The nutrition education curriculum was first tested in a subgroup (10% of sample) of patients not involved in the study before the actual implementation. The aim of the physical activity was to ensure that patients accumulate a minimum of 150 min of moderate intensity exercise each week from personal activity at home that includes walking, digging, jogging, cycling, house hold duty, aerobics and sport activities. The participants were encouraged to perform the exercise at least 3 days each week with no more than two consecutive days without exercise. During the intervention the patient were led through the importance of physical activity as well as demonstration on activities they can do at home by an experienced physiotherapist in diabetes management. The participants were encouraged to continue with the exercises at home in addition to normal routine work. Participants in the NEP group were grouped in small support group (5-10 participants) depending on the location they came from as well as age cohort during the intervention period and these groups continued during the follow up period. After each education session they were encouraged to set and share with each other weekly goals for specific changes in their eating and physical activity behavior aimed at making healthy food choices, reduction of portion sizes and being active. The patient reported on their progress to the group members at the beginning of the next session. 51
Experimental Group Nutrition Education Programme and its Effect on Type 2 Diabetes Attending Care at Thika Level 5 Hos 2 hours 8 week session 8 weeks and six month follow up nutrition education and one session of physical activity with no peer to peer support 51
Control Group control group C 2 hours, 8 week standard care and 6 month follow up 6 month standard education that covered content on diabetes pathophysiology, risk factors, symptoms, complications, hyperglycemia and hypoglycemia symptom and foot care treatment goals and modalities and standard care which included routine blood glucose motoring, blood pressure and treatment of any ailment 51 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients suffering from Type 2 diabetes aged between 20-79years attending diabetes comprehensive care centre regular, not pregnant; with no complication like renal failure, congestive heart failure, stroke and not planning to move from the study area during the study period. patient with type 2 diabetes who pregnant, had complication like renal failure, congestive heart failure Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 79 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/06/2016 Kenyatta National Hospital University of Nairobi Ethics and Research committe
Ethics Committee Address
Street address City Postal code Country
P.o Box 20723 Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome METABOLIC SYNDROME AFER SIX MONTH
Secondary Outcome Adherence to lifestyle modification after six month from end of intervention date intervention
Secondary Outcome health cost incurred by type 2 diabetes patient after six month from end of intervention date intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Thika level 5 hospital p.o box 227 thika 0100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
African Population Health Centre p.o box 10787 Nairobi 00100 Kenya
Jomo Kenyatta University of Agricultuure and Technology P.O BOX 62000 Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jomo Keyatta University of Agriculture and Technology P.O Box 62000 Nairobo 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Prof. Anselimo Makokha P.O Box 6200 Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ann Thuita awambugu78@gmail.com +254721783766 P.o Box 62000
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Lecture
Role Name Email Phone Street address
Public Enquiries David Mbogo mbogomd@gmail.com +254722 P.o Box 227
City Postal code Country Position/Affiliation
Thika 01000 Kenya Medical Doctor
Role Name Email Phone Street address
Scientific Enquiries Anselimo Makokha amakokha@jkuat.ac.ke +254713817436 P.o Box 62000
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Lecture
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the trial period Informed Consent Form,Study Protocol Beginning three months and ending 36 month following article publication Researchers working in the area of type 2 diabetes and non communicable disease whose proposed use of data has been reviewed by an independent review committee identified for this purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://www.sciencepublishinggroup.com/journal/paperinfo?journalid=278&doi=10.11648/j.ijd Yes Changes in metabolic syndrome six month post intervention were - 38.1% and -31.9% for nutrition education peer support group;-16.9% and -10.6% for nutrition education group and + 3.1% and + 8.9% for control group as per harmonized and world health organization criteria (p<0.01). Additional an improvement in adherence level to lifestyle modification that was significant ( P<0.01) six month post intervention. The nutrition education peer support group showed the greatest improvement (+32.4% improvement in diet adherence and +1105.4 metabolic equivalent minutes per week improvement in physical activity) followed by nutrition education group (+19.92% improvement in diet adherence and +380.12 metabolic equivalent minutes per week improvement in physical activity) with control group showing the lowest improvement (+9.99% improvement in diet adherence and +103.40 metabolic equivalent minutes per week improvement in physical activity. There was significant change (p>0.05) in health care cost incurred by the participant six moth post intervention ( Ksh. + 99.9 in nutrition education peer support group, Ksh+22.7 in nutrition education group and Ksh.-3.77 in control group) 07/10/2019 10/05/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks I have not published the protocol
Changes to trial information