Effect of a nutrition education programme on metabolic risk factor and metabolic syndrome in adults with type 2 diabetes mellitus at a Level 5 Hospital in Kenya: “a randomized controlled trial”

Background Type 2 diabetes mellitus; a chronic disorder characterized by poor glycemic control, is a life threatening condition of global public health concern which worsens in the presence of metabolic syndrome (MetS) and associated risks. However application of lifestyle intervention may reduce this risk. The aim of the current study was to evaluate the effect of nutrition education programme with inclusion of peer to peer support on MetS and Mets risk factors in type 2 diabetes mellitus patient. Methods This was a randomized controlled trial with two intervention groups and one control. The intervention groups included nutrition education peer to peer support group (NEP) (n=51) and nutrition education group (NE) (n=51) which participated in an eight week (2 h per week) group nutrition education sessions and follow-up sessions for six month. The NEP in addition had a peer to peer support component on weekly basis for the eight weeks of training and monthly support for six months. The control group (C) (n 51) received standard care. Outcomes were assessed at 6 months. An intention-to-treat analysis was conducted using analysis of co-variance (ANCOVA). Results: Differences in MetS were -38.1 and -31.7% (P<0.01) at 6 months in the NEP group as per Harmonized and WHO criteria respectively. Significant improvement was seen in number of participant achieving recommended waist circumference; WC (33.9 %) and high density lipoprotein; HDL (35.2%) in the NEP group and blood pressure; BP (reduction by 39.2 and 31.6) as per harmonized and WHO criteria respectively in the NE group. six month post intervention Statistical mean change was also noted six month post intervention in; weight lost (-6.26kg), BMI (-2.37 kg/m 2 ), waist hip ratio; WHR (-0.03), WC (-14.51 cm) and HDL (+0.34mmol/l in the NEP group and diastolic blood pressure; DBP (-5.17 mmhg) in the NE group. Comparison of the NEP and NE with control showed that NEP and NE had better outcome.

Type 2 Diabetes mellitus is heterogeneous metabolic disorder characterized poor glycemic control [1].
It is a global public health problem and one of the most common life threatening condition globally due to its related complication with more and more people living with condition each year [1][2][3][4]. It is a debilitating and costly disease that undermines economic development of a country due to it is associated morbidity and mortality [3,4]. Type 2 Diabetes cost everyone, not just those with diabetes, however, the largest costs are not on expenditure for diabetes care, they are on disability, management of complications and economic stagnation [1].
Type 2 diabetes mellitus is related to Metabolic syndrome (MetS); a cluster of interrelated clinical factors that include insulin resistance, dyslipidemia, excess weight and elevated blood pressure [2].
However data on existence of MetS in Type 2 Diabetes mellitus population as well as intervention to address MetS in Type 2 diabetes mellitus in in Kenya have not been reported.
Metabolic syndrome (MetS) in Type 2 diabetes mellitus has been associated with several metabolic factors. These include obesity a major determinant of insulin resistance, elevated waist circumference, dyslipidemia and increased blood pressure [2,[7][8][9][10][11]. These factors are also significant to progression of Type 2 Diabetes mellitus as well as related complication. An upward trend in these risk factors has been reported and this pose a greater challenge due to increased health cost, morbidity, and mortality [18,[30][31][32][33].
Lifestyle and behavioral factors play an significant role in the development of Type 2 Diabetes mellitus as well as MetS in Type 2 diabetes mellitus patients [34][35][36]. Lifestyle intervention including nutrition education and physical activity has been shown to be effective in improving clinical outcomes in individuals with Type 2 diabetes mellitus as well as improving metabolic outcomes in Type 2 diabetes mellitus patients [34][35][36][37]. However, achieving lifestyle modification that include among others; healthy diet and, physical activity is often the most challenging aspect of care to accomplish in patient management. This might be due to poor self-control, lack of information, financial constraints among others. This can be improved through health education and awareness creation on positive lifestyle changes aimed at addressing deleterious effects of an unhealthy diet (high intake of fat, sugar and salt) and physical inactivity on patient condition [36,38]. Inclusion of peer support might aid in management of the condition further.
Peer to peer support in chronic disease management (like Type 2 diabetes mellitus, Mets) have been shown to provide social and emotional support, help people apply disease management or prevention plans in daily life and link individuals with clinical, community, and other resources [39][40][41].Additionally studies have shown that effectiveness of diabetes education on lifestyle modification can be enhanced further through inclusion of peer to peer support [40,[42][43][44][45][46]. However, despite the established role of lifestyle intervention and peer to peer support in improving Type 2 diabetes mellitus and MetS risk factor control, its contribution to Type 2 diabetes mellitus and MetS management in Africa, including Kenya, is not well established. Therefore the purpose of the present study was to implement a nutrition education (NE) programme with peer to peer support and evaluate its effect on, MetS and MetS risk factors on adults with Type 2 Diabetes

Study setting
The study was conducted at Thika Level 5 Hospital (TL5H) in Kiambu County, Kenya at the Diabetes Comprehensive Care Clinic (DCC) which attends to approximately one hundred patients per week and has an average of one thousand patients [47]. The DCC is an out-patient clinic that operates on a daily basis. Diabetic patients, self and non-self-referred from the County and nearby areas attend the clinic on appointment days for routine blood glucose monitoring, medical checkup (blood pressure) and nutrition status checkup (body mass index; BMI), treatment and collection of medication. Newly diagnosed patient with either Type 1 or Type 2 Diabetes mellitus are also referred here from other clinic (either from the hospital or neighbouring healthy facilities) for further management. The clinic serves both male and female with Type 1 diabetes mellitus and Type 2 diabetes mellitus. The patients are mainly from low and middle income social economic background. During the clinic day health talk on general diabetes care management with minimal demonstration is given. However the education given is not exhaustive as only thirty minutes are allocated. The content covered during the health talk has a very small component on nutrition and physical activity component that is given with no demonstration. In addition the patient arrived at different times therefore, not all who benefits from the talk. This call for a detailed programme aimed at enhancing patient nutrition knowledge level using nutrition and exercise management in relation to Diabetes. The current study aimed at studying the effect of nutrition education programme with peer to peer support on MetS indicators and MetS in Type 2 diabetes mellitus patient.

Study design and ethics
This was a randomized controlled trial with two intervention group (nutrition education; NE and Nutrition education and peer to peer support; NEP) and a control group(C). The study was approved by the Kenyatta National Hospital-University of Nairobi Ethics and Research Committee (Permit No. KNH-ERC/A/232) and the National Commission for Science, Technology and Innovation (NACOSTI) (Permit No. NACOSTI/P/16/83452/10118). Study participants gave a written informed consent

Study participants
Study participants were men and women aged 20-79 years with Type 2 diabetes mellitus attending the Diabetes Comprehensive Care (DCC) center at TL5H. They were recruited during their daily clinic attendance while waiting to see a health professional. Recruitment was done over a period of 2 months from August 2016 to October 2016. All patients who met the following criteria were selected: patients suffering from Type 2 diabetes mellitus aged between 20-79years, regular attendance at the DCC; 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. A total sample size of 153 patients was recruited for the study.

Sample size determination
To confer 90% power at 5% level of significance and detect an absolute effect size of 30% improvement on metabolic syndrome (MetS) in Type 2 diabetes mellitus patient (i.e. from 45% to 15% with intervention), we needed to include 46 study participants in each study arm using the formula by Armitage et al., [48] and Lwanga and Lemeshow [49]. The sample size was subjected to a correction factor of 10% to cater for attrition thus each arm had 51 participants making a total sample size of 153 patients.

Randomization
The study consisted of three groups, two intervention groups nutrition education peer to peer support group (NEP) and nutrition education group (NE) that received nutrition education with peer to peer support and nutrition education respectively and control group (C) that received standard care.
Participants were randomized to either of the intervention groups or control group with the use of random numbers. To allow equal chances for participants, randomization was stratified on the basis of sex and age. Sealed sequentially numbered opaque envelopes per each stratum (1-3) mixed using the lottery method were used. The participants were requested to pick an envelope each and join their groups (1)(2)(3). A volunteer from each group was then requested to move forward and pick another envelop each containing their treatment allocation (NE, NEP and C). Upon confirmation of the treatment allocation, the participants were allocated to their treatment group by the principal investigator (PI), and the group members recorded. Each group was assigned 51 participants. After randomization baseline data was collected from all the participants.

Intervention
Before random assignment to control or intervention groups, all study participants received standard education that covered content on diabetes pathophysiology, risk factors, symptoms, complications, Different teaching method that included lecture, discussion demonstration role play and group work were used to deliver the information. After the standard education, one of the intervention group received eight week nutrition education in combination with importance of physical activity (NE group), while the second group received nutrition education, importance of physical activity programme with peer to peer support emphasis (NEP group). The control group received the standard education given to all groups and standard care. The nutrition education included weekly (120 minutes each) nutrition classes conducted over eight weeks by the researcher. The nutrition education curriculum was developed by the PI after review of related literature on nutrition management of diabetes and importance of peer to peer support in management of diabetes. The PI also applied her experience gained in her practice as a nutritionist. The NE curriculum was written in English and supplemented by photos and illustrations to help the patient understanding the content better.
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 their importance in blood glucose control; food pyramid and its use together with food exchange list (Table 1). 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 physical activity lesson were adapted from the WHO strategy on diet and physical activity and health [51] WHO Global recommendation on physical activity for health [52] and Kenya Diabetes Educator manual [53] which were modified by the researcher with the help of a physiotherapist to suit the study patient. 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.
Previous studies have highlighted the importance of peer support in management of chronic conditions [54]. 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. After the eight weeks training sessions the patient were followed and their goal presented to other members in the subgroup on monthly basis for six month. A trained peer educator living with diabetes for 13 years from Kenya Defeat Diabetes Association (KDDA) joined the PI during the monthly meeting and encouraged the patient in the peer support groups by sharing his experience.
Together with the PI he also assisted them review their goals during monthly meeting and if there was any adjustment required done. Also group counseling was done on each visit for patient requiring more support. The intervention was done for a period of eight weeks which was adequate for the implementation of the curriculum. The implementation started from last week of 24 th October 2016 to 23 rd December 2016.

Follow up
The intervention run for eight weeks and follow up done monthly. After the end of the eight weeks intervention the patient were requested to be coming to the hospital monthly on selected days for follow up. At the start of the study the patient were given appointment cards developed by the PI indicating the day they are supposed to come for the appointment. The researcher also got phone numbers for the participants which assisted in follow up. A call was given to the participant reminding them on the appointment one week to the appointment day and two days to the appointment day to ensure they avail themselves. Those who did not turn up would be given another day and be reminded again of their appointment. For those who could not make to come after second reminder, they were followed in their home and requested to come for the appointment. This prevented loss to follow up. Patient in the NEP group continued with peer to peer support during the follow up period.

Measurements
Data on weight, height, waist circumference, blood pressure and fasting blood sugars; were obtained at baseline and monthly for a period of six months. Data on glycated hemoglobin and lipid profile (HDL, LDL, total triglycerides and total cholesterol) was collected at baseline and after six months. A physician and clinical officer were also present during the study period to manage any patient requiring medical treatment.

Anthropometry and clinical data
Anthropometric measurement that includes weight, height, waist and hip were collected at baseline, during monthly follow up and post evaluation after six months. Waist circumference was measured mid-way between the lower rib margin and the iliac crest with flexible anthropometric tape the nearest 0.5 cm while hip circumference was measured as the maximal circumference around the buttocks posteriorly and pubic symphysis anteriorly.

Blood pressure
Blood pressure of the patient was also taken monthly. It was measured in the supine position using a mercury sphygmomanometer (model: Autortensio® noSPG440) by trained nurses with at least a 10min rest period before the measurement.

Metabolic syndrome definition
Metabolic syndrome in the study was defined according to the definition of WHO [64] and "Circulation for Harmonizing the Metabolic Syndrome" criteria [2,11], The later requires the presence of at least three of the following five components: Fasting blood sugar of 100mg/dl or 5.6mmol/l or drug treatment of elevated glucose, central obesity for Africans (waist circumference ≥94 cm in males and ≥80 cm in females), elevated triglycerides (≥1.7 mmol/l or 150mg/dl and/or the use of triglyceridelowering drugs), reduced HDL cholesterol (<1.0 mmo/l or <40mg/dl in males and <1.3 mmol/l or 50mg/dl in females) and elevated blood pressure (systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg and/or the use of antihypertensive drugs).
World Health Organization criteria also requires the presence of Type 2 diabetes mellitus, impaired glucose tolerance or insulin resistance, and any two of the following: (1)

Data analysis
The data was analyzed using statistical package for social science (SPSS version 20

Participants
One hundred and fifty three participants (153; 40.5% male and 59.5% female) were included in the study. As shown in Table 2 there was no significant difference in the baseline characteristic of the study participant. Additionally out of one hundred and fifty three (153) participants who were randomized, one hundred and forty three (143; 93.5%) completed the study.  Additionally a significant mean increase in HDL [f (2,124), p=0.01]) was also seen between groups with NEP group exhibiting the greatest increase in HDL (+0.34mmol/l) ( Table 3). There was an increase in LDL levels [f (2, 124) p=0.04] in the entire group that was significant with C group having the greatest increase (1.23mmol/l).
Furthermore post intervention significant mean difference (p<0.05) between the NEP and NE as well as NEP and control (C) was seen in weight lost (4.99 kg and 6.89kg respectively); BMI reduction (1.89 kg/m 2 and 2.67 kg/m 2) respectively ) ; WC reduction (9.73cm and 16.46cm respectively) and WHR reduction (0.03 and 0.04 respectively) respectively (Table 3). Post intervention significant mean difference between NEP and NE was seen TG (0.52mmol/l) and HDL (0.28mmol/l) ( Table 3). Moreover post intervention significant mean difference between NEP and C was also seen in HC (10.20cm), HbA1c (1.30%), TC (0.69mmol/l) and LDL (0.86mmol/l) with a difference of 4.99kg and 7.06cm respectively (Table 3). There was no significant mean difference for the other metabolic parameters between the intervention groups (NEP and NE) and C group ( Table 3).
As shown in Table 4 (Table 4).   [40].Decrease in the WC, WHR, and BMI indicate reduced risk in cardio-metabolic risk [89][90][91]. Study have also shown strong correlation between BMI and WC with glycaemia, triglyceride, HDL and blood pressure [92]with reduced level of BMI and WC being associated with low MetS prevalence which is in concordance with our study In interpreting the result of this study some limitation need to be considered. The study period was limited to six month and this allowed assessment of short-term effect of the intervention. Longer period of follow-up have been recommended in order to understand more of the sustainability of a peer-led intervention program and also in order to ensure long-term reduction of metabolic risk in type 2 diabetes mellitus Additionally the study was carried out in a public hospital setup where patient population is of middle and low income that refer them freely for care hence the results can only be compared to a similar population. The current study reported significant improvement of metabolic parameters and MetS prevalence on application of lifestyle intervention and might be a useful base for community based study targeting Type 2 Diabetes population. The current study was also unique as it incorporated peer to peer support in management of Type 2 Diabetes hence contributing to its strength. The study also had a high retention rate (93.7%) and received positive feedback from patient on their monthly visits that were encouraging.

Conclusion
In conclusion nutrition education programme with inclusion of peer support in for individuals with The study have been registered by Pan African Clinica Trial Registry; Registration No.

Availability of data and materials
All the data set used and/or analyzed during the current study are in custody of Thuita Ann and are available on request.

Figure 1
Flow of the participants throughout the study

Supplementary Files
This is a list of supplementary files associated with this preprint. Click to download.
CONSORT 2010 Checklist.doc for Ann Study.doc