The primary objective of this clinical trial is to evaluate the effect of an online educational intervention together with the mobile app "I understand my diabetes" compared to those of using the website and receiving usual care on the metabolic control of the patient with T2D.
The secondary objectives are to evaluate the effect of the intervention on:
- Lipid profile through measurement of total cholesterol, LDL-c (low-density lipoprotein cholesterol), HDL-c (high-density lipoprotein cholesterol), and triglycerides.
- Body composition and anthropometric measurements by assessing fat percentage, fat mass, weight, BMI (body mass index), and WC.
- Quality of life through Diabetes 39, validated in the Mexican population.
- Lifestyle, through IMEVID, validated for diabetes population in Mexico.
- Level of physical activity through IPAQ (International Physical Activity Questionnaire).
Study designation and population
A randomized controlled trial with a parallel-group design conducted at six family medicine clinics of the Mexican Social Security Institute in Mexico City, with a 12-month follow-up. This study complies with international ethical standards and was approved by the National Research and Ethics Commission of the Mexican Social Security Institute, under the registration number R-2018-785-100. For the sample size calculation, a minimum expected difference in A1c of 1% will be considered in the group with the mobile app "I understand my diabetes” and educational website compared to the group with only website and control group. An α error of 0.05, and a power of 80%, with a standard deviation of the reference group response variable of 1.3% will be assumed. (23) The formula for mean comparison will be used, along with a sample size of 113 participants from each group, considering a 20% loss; a total of 136 patients will be included in each of the three groups.
Selection criteria
The study will involve patients who have been previously diagnosed with T2D by their treating physician, with A1c > 7% and < 13%, with and without pharmacological treatment for diabetes (hypoglycemic agents or insulin). Participants must be literate, have access to a home computer or a smartphone and Internet connection, and be ≤ 60 years old with ≤ 10 years of diabetes diagnosis. Patients with severe complications of the disease (chronic renal failure, blindness, or amputation), requiring specialized medical and nutritional care will be excluded as well as patients with morbid obesity (BMI ≥ 35 kg/m2).
Selection criteria for study. See Fig. 1.
Protocol management
The objectives and activities of the project will be explained to the authorities and permission will be requested to conduct the study at the selected clinics. The following three groups will be randomly assigned (two clinics per group):
1 Educational website. See Figure 2
2 Figure No. 2. Web site "I Understand my diabetes".
Educational website and mobile app "I Understand my diabetes" for glucose monitoring, diet, and personalized exercise. See Figure No. 3.
Figure 3. Educational website and mobile app "I Understand my diabetes"
3 Control group with usual medical and educational treatment.
The participating researchers will provide information about the study to the patients, answer their questions and, once patients decide to participate voluntarily, ask for informed consent.
Sociodemographic and clinical measurements
Information on sociodemographic data, pathological history, and clinical data (pharmacological treatment and current comorbidity) will be collected by the clinical staff. Blood pressure will be measured twice with a mercury sphygmomanometer with an interval of 5 min between measurements. Afterwards, the patient will remain seated for more than 5 min; the blood pressure value will be the average of the two measurements.
Biochemical measurements
After a 12 h fasting period, venous blood samples will be obtained from the patients. The A1c levels will be measured by high-performance liquid chromatography. Serum levels of fasting glucose, total cholesterol, LDL-c, HDL-c, and triglycerides will be analyzed by automated photometry.
Anthropometry and body composition measurements
Anthropometry will be recorded by two previously trained nutritionists and standardized according to the method proposed by Habitch and the specifications described by Lohman et al. (24, 25) Weight (kg) and height (cm) will be obtained for the calculation of BMI in an Inbody® device (model BPMO40S12F07). Additionally, WC will be measured at the midpoint between the lower rib and the upper edge of the superior iliac crest on the right side. Hip circumference (HC) will be measured at the greater diameter of the trochanters.
The measurements will be recorded three times and the mean value of the second and third measurements will be used for analysis. Body composition will be obtained in an InBody device for bioimpedance measurement, as described previously. This measurement will include fat percentage and kilograms of fat mass and lean mass.
Dietary measurements
A 24-hour dietary recall will provide an overview of the diabetes patient’s usual diet, from which the nutrition professional will evaluate the calories and macronutrients typically consumed, food quality, tastes, and preferences. The dietary measurement will be collected by the nutrition professional at each patient visit.
Physical activity measurements
The IPAQ will be used to measure the level of physical activity. This questionnaire consists of 7 items that indicate the time of physical activities performed in the last 7 days (hours, minutes, and days per week). The physical activity will be classified after considering the METs (unit of measurement of the test) of the activity; then, physical activity will be classified in three categories: low, moderate, and high. (26)
Quality of life measurements
Quality of life will be measured using the Diabetes-39 questionnaire, which has been validated in the Mexican population. The questionnaire contains 39 items distributed in five sections: Energy-Mobility, Diabetes control, Anxiety-concern, social burden, and sexual functioning. It is scored on a scale from 1 to 7, (1 for not at all affected and 7 for extremely affected in quality of life). The score of each section is transformed to a scale from 0 to 100 using a formula for linear conversion. (27)
Lifestyle measurements
The IMEVID instrument (Instrument for measuring lifestyle in patients with diabetes) will be applied. It consists of 25 closed questions grouped into 7 dimensions: Nutrition, Physical activity, Tobacco consumption, Alcohol consumption, Information on diabetes, Management of emotions, and Compliance with treatment. Each item presents three response options with scores of 0, 2, and 4, where 4 corresponds to the maximum desirable value in each response, for a total score from 0 to 100. (28)
Clinical management
The health professionals of each clinic (physician and/or nutritionist) will have credentials to access the clinical management platform "I Understand my diabetes" in order to capture sociodemographic, comorbidity, clinical, biochemical, anthropometric, body composition, lifestyle, quality of life, diet, and physical exercise data. From these data, the system will provide a diet and a physical exercise plan previously designed by physicians and nutrition researchers participating in the platform, considering the clinical data recorded by the health professionals. This clinical management system of the health professional can be seen in Fig. 4.
Figure 4: Patient clinical information
All patients will receive a personalized dietary plan according to their current weight and current comorbidity for dietitian participant, consisting of 15–20% protein, 50–55% carbohydrates, and 25–30% fat; saturated fat will represent < 7%. The menus will feature a calorie content of 1200–2600 calories, considering the most frequent comorbidities in patients with diabetes, such as dyslipidemia, arterial hypertension, and renal disease, together with tastes, habits, and economy.
Group with educational website program
Patients will receive the educational intervention with the web site called "I Understand my diabetes", designed by a group of clinical experts in diabetes, including physicians, nutritionists, diabetes educators, and epidemiologists. This educational site was previously validated by a consensus of experts in the treatment of diabetes, and its usability by patients with type 2 diabetes was identified. (18, 29)
The educational course is available on the Moodle platform http://entiendomidiabetes.com/moodle28/login/index.php.
The course comprises modules on understanding diabetes, pharmacological treatment, control indicators, nutrition, myths related to diabetes, complications related to the disease, depression, and family support. These modules are designed to be easy to use, incorporating visual resources, minimal text, and videos to facilitate the understanding of the educational content.
Each module includes didactic or reinforcing activities aimed at motivating patients to actively self-manage T2D. Patients will receive a personalized meal plan, according to their current weight and comorbidity. Prototype menus will be provided to improve adherence to the diet. The patient will be awarded with a Diploma once the 10 modules are completed.
Group with mobile app + educational website program
Patients assigned to this group will receive access to the educational website and the mobile app. The app will provide them with a meal plan as the other groups will; however, unlike the others, they will be able to plan their diet autonomously. The plan will indicate established calories and color signaling in green, red, and orange to remind the patient of the group to which foods belong and glycemic index. In addition, patients will be able to make food exchanges that will allow them to create a more varied diet. In addition, patients will be able to view their BMI graph and recorded glucose and A1c values, allowing them to identify the evolution of their indicators over time. On the app, the patient will access a physical exercise section, reminders, and time count to perform physical activity. The mobile app "I Understand my diabetes" is already available on Android operating system, and is currently undergoing usability testing, as shown in Fig. 3.
Group with usual care
The control group will receive a personalized diet plan, designed by nutrition professionals participating in this study, considering current weight and comorbidity. Prototype menus will be provided to strengthen adherence to the diet plan. General recommendations for physical exercise will be given as established in the national consensus for the promotion of physical exercise in patients with diabetes.
Follow-up and procedures
The total period of the study will be 12 months, and the patients will attend a face-to-face consultation every 3 months, as shown in Fig. 5.
Figure 5. Follow-up and procedures.
At the beginning of the intervention and at 12 months, clinical, anthropometric, and dietary variables (24-h food recall) will be evaluated, while biochemical, lifestyle, quality of life and physical exercise variables will also be measured. Visit time points and assessments are summarized in Table 1.
Table 1
| |
|
Months
|
| |
Basal
|
3
|
6
|
9
|
12
|
|
Medical examination to obtain sociodemographic and clinical data, measurement of systolic and diastolic blood pressure
|
X
|
|
|
|
|
|
Biochemical data in blood sample (A1c, glucose, serum creatinine, total cholesterol, triglycerides, LDL-c and HDL-c).
|
X
|
|
|
|
X
|
|
Measurements of body weight, height, waist circumference, fat percentage, fat mass and lean mass
|
X
|
X
|
|
X
|
X
|
|
Medical and nutritional therapy, 24-hour food reminder record.
|
X
|
X
|
|
X
|
X
|
|
Lifestyle (IMEVID), Quality of Life (Diabetes 39) Physical Activity Level (IPAQ)
|
X
|
|
|
|
X
|
|
Creation of users to the educational website and/or mobile App
|
X**
|
|
|
|
|
|
Telephone call to reinforce the intervention group
|
|
|
X
|
|
|
| ** For groups with educational website and mobile app + educational website. |
Table 1. Schedule of assessments
The inclusion and follow-up of patients in the study is presented in Fig. 6. adheres to the guidelines of the Standard Protocol Elements for Randomized Clinical Trials.
Figure 6: Flow diagram of the study. The expected flow of patients with diabetes in the different phases of the study.
Results of the study
Primary objective. The primary objective of the study is to evaluate the effect on metabolic control through the measurement of A1c levels and fasting glucose before and after 12 months of intervention. The measurement will be considered a continuous variable to identify achievement in metabolic control from A1c. To achieve the secondary objectives, we expect to measure the effect on lipid profile (total cholesterol, LDL-c, HDL-c, and triglycerides) by the change in concentration before and after intervention and between groups. The effect on weight, BMI, fat percentage, fat mass, and waist circumference will be considered a quantitative variable. The assessment of lifestyle through IMEVID, validated in the population with diabetes in Mexico, will be treated as a categorical variable, ranging from adequate and regular to inadequate lifestyle. Quality of life will be assessed through Diabetes-39, which includes different components of quality of life and will be analyzed as a categorical variable.
Statistical analysis
Descriptive statistics will be used with measures of central tendency and dispersion for quantitative variables that have a parametric distribution; variables with free distribution will be reported in median and interquartile range, and will be presented in summary measurement tables. One-way ANOVA or Kruskal Wallis test will be used to compare the effect on clinical, anthropometric, and biochemical variables between groups. An X2 test will be used to evaluate the effect of the intervention between groups for metabolic control goals.
A logistic regression model will be used to identify the effect of the intervention on the primary target variable, A1c, as a dichotomous variable in glycemic control and uncontrol. It will be adjusted for other variables, such as intervention group, years of diagnosis, physical exercise, schooling, marital status, and occupation.