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 (1-3). 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, hyperglycemia and hypoglycemia symptom and foot care treatment goals and modalities. This was done by the principal investigator (PI) together with a clinician who runs the clinic (Registered Clinical Officer with a Bachelor of Science degree in Clinical medicine). Pictorial flip charts and additional learning material with diabetes management information adapted from MoPHS diabetes prevention and management guideline [50], NorvoNodisk changing diabetes poster as well as MOH diabetes posters in addition to what the(PI) had prepared after review of different literature were used. 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 24th October 2016 to 23rd 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.
Table 1: Nutrition education curriculum
Week
|
Topic
|
Content and activities
|
Participants
|
Introduction week
|
What is diabetes and how it is managed
|
Nature of disease (explanation of what happens when one has diabetes, including body’s response to food in diabetic/non-diabetic states, insulin action, causes/risk factors, types)
Symptoms and complications
|
All participants
|
|
|
medication and their roles in treatment
|
|
|
|
Aim for treatment and targets for good control
|
|
|
|
Causes, symptoms and management of hypoglycemia and hyperglycemia
|
|
|
|
Foot care and eye care.
|
|
|
|
|
|
Week One
|
Dietary guidelines on healthy eating
|
Principal of healthy eating: importance of regular and varied meals
|
Intervention groups
|
|
|
Guided discussion on improving dietary variety
|
|
|
Dietary guidelines continued; Overview of food groups and their role diabetes management
|
Cereals and starches as well as root and tuber groups and their role in diet
Different type of starches and cereals, carbohydrate content and how it affects blood glucose
Some healthy ways to include starches in meals
Demonstration of portion/serving sizes of different cereals and starches
Group work: practices on portioning and serving of starches
|
|
|
|
Specific guidelines for cereals preparation
|
|
Week Two
|
Dietary guidelines continued; Overview of food groups and their role diabetes management
|
Legumes group and nut and seed groups and their role in diet
Carbohydrate content in legumes and how it affects blood glucose
Different type of legumes, seed and nuts that can be used by Type 2 diabetes mellitus patient.
Some healthy ways to include legumes, seed and nuts in meals
Demonstration of portion/serving sizes of different cereals and starches
Group work: practices on portioning and serving of legume and nuts
Specific guidelines for cereals and legumes preparation
|
Intervention groups
|
Week Three
|
Dietary guidelines continued; Overview of food groups and their role diabetes management
|
Meat , dairy group and their role in diet
Their role in diabetes management
Trimming of fat in meat
Reduction of cream in milk
Different milk product and how to include different serving portion
Importance of minimizing of processed meat in diabetes and chronic disease management
|
Intervention groups
|
Week Four
|
Dietary guidelines continued; Overview of food groups and their role diabetes management
|
Vegetables and fruits
How to improve vegetables supply at home
Importance of vegetables and fruit in diabetes management
Carbohydrate content in fruits and vegetables and how it affects blood glucose
Demonstration of different vegetables and fruits
Group work: participant in groups to name different fruit and vegetables demonstrated and indicate how they will improve their supplies
|
Intervention groups
|
Week Five
|
Dietary guidelines continued; Overview of food groups and their role diabetes management
|
Fats and oil and their role in diet
Importance of fat and oil
Sources of fat
Type of fats (saturated and unsaturated), Their sources and effect of each in the body.
Some healthy way to include fat and oils in the diet
|
Intervention groups
|
|
|
Group activity: label reading of fat and oil products on display and identification of different content of different component of triglycerides, saturated fat and unsaturated fat levels.
|
|
Week Six
|
Meal planning: portions and meal frequency
|
Facilitated group review of the effect of different food group on blood glucose
|
Intervention groups
|
|
|
Discussion on importance of food portion control and regular meals
|
|
|
|
Guidelines for portion sizes
|
|
|
|
Demonstration: portion sizes (household measures, Zimbabwe hand jive, plate model )
|
|
|
|
Group activity: practice portioning various commonly used foods
Reflection and group discussion about portion sizes and associated issues such as hunger
|
|
|
|
Planning meals on a limited budget, emphasis on variety and balance within available resources
|
|
|
|
Importance of timing and combining meals
|
|
Week Seven
|
Glycemic index and its importance in diabetes management
|
Role of glycemic index and glycemic load in blood glucose control
Glycemic index and glycemic load of different foods
|
Intervention groups
|
|
|
Examples of glycemic index of various foods
|
|
|
|
Group activity: classifying food in terms of glycemic index
Label reading of different foods: reflection on current practices related to dietary guidelines and label reading plus group discussion
|
|
Week Eight
|
Physical activity
|
Importance of physical activity in blood glucose control
When to exercise
|
Intervention groups
|
|
|
Group activity: demonstration of the exercises by group leaders and
All participant participate in exercise programme
|
|
|
Post Evaluation, Handouts: pamphlet and wall poster
|
Post evaluation and issue of handouts, pamphlets and wall posters
|
All
|
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. Height and weight were measured using standard methods with the participant wearing light clothes and no shoes[55]. The weight was determined to the nearest 0.1kg using a calibrated electronic weigh scale (Seca) and height to the nearest 0.1 cm using a stadiometer attached to the weighing scale. Body mass index (BMI) was then be calculated as weight (kilograms)/height (meters) 2 and classified as per WHO classification [55]. The waist circumference and hip circumference were measured according to standard guideline[56]. 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 10-min rest period before the measurement.
Laboratory assay
Blood samples were collected from each participant while in a seated position after fasting for at least 8-12hrs for determination of serum triglycerides (TG), total cholesterol (TC), high density lipoprotein (HDL-c), low-density lipoprotein cholesterol (LDL-c), glycated hymoglobin (HbA1c) at baseline and 6 month post intervention. Fasting blood glucose was determined monthly. Levels of serum TG, total cholesterol (TC), high density lipoprotein (HDL-c), low-density lipoprotein cholesterol (LDL-c), were determined by enzymatic method[57–63]. Glycated Hemoglobin (HbA1c) and blood glucose were determined using high-performance liquid chromatography and glucose oxidase method respectively [64,65].
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 triglyceride-lowering 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) body mass index (BMI) ≥ 30 kg/m2 and/or waist-to-hip ratio >0.90 (male), >0.85 (female); (2) blood pressure ≥140/≥90mmHg or on hypertension medication; and (3) triglyceride ≥ 1.7mmol/Land/or HDL-C < 0.91mmol/L (male), <1.01mmol/L (female).
Data analysis
The data was analyzed using statistical package for social science (SPSS version 20). Data are present as means ± SD or SE for continuous variables and percentages for categorical variables. Chi square test was used to compare groups for categorical variables and Analysis of Co-variance (ANCOVA) was used to compare means difference between groups. Statistical significance was considered for p value <0.05.