The Effect of a cognitive behavioral program based on an interactive application on serum glucose levels and HbA1C of family members of patients with type 2 diabetes: a study protocol for a randomized clinical trial

Abstract

Background

The families of diabetics are more likely to have diabetes. Therefore, paying attention to those households and seeking to change the way of life of those households can save diabetes to a high extent. The present study aimed to investigate the impact of cognitive-behavioral applications primarily based on interactive software on serum glucose levels and HbA1C of a family member of sufferers with kind 2 diabetes.

Methods

In the present randomized clinical trial, families of diabetic patients meeting the inclusion criteria will be divided into intervention and control groups by simple random sampling. In the laboratory, 10 cc of blood samples will be taken from the participants for the tests of total cholesterol, triglyceride, fasting blood sugar, GTT, HDL-c, LDL-c, and HbA1c. Then, both groups complete the International Physical Activity Questionnaire, Adolescence Food Habit Checklist, and Glover Nilsson Smoking Behavioral Questionnaire (GN-SBQ). The intervention group will provided with a training package of lifestyle change based on a cognitive-behavioral program in the form of an application during eight sessions of 45 min in 8 weeks. Then, the laboratory tests and questionnaires will be completed again 6 and 12 months after the intervention. Data will be analyzed using statistical tests.

Discussion

If an application-based cognitive-behavioral program changes the lifestyle, serum glucose levels, and HbA1C, it can be recommended to families of diabetics.

Introduction

The World Health Organization (WHO) has predicted that diabetes will be the seventh cause of mortality by 2030, and most of the cases will be diabetes type 2 [1]. Over 4,000,000 people suffer from this disease in Iran, and the Iranian population of diabetes patients is predicted to reach 6,000,000 people by 2030 due to aging, increased prevalence of obesity, and changes in people’s lifestyle and diets [2, 3]. This will include 6.8% of the national population by 2025 and is the most prevalent cause of non-traumatic amputation, kidney diseases, and blindness [4]. Although the accelerating prevalence of type 2 diabetes is quite evident in the elderly, its recently increasing prevalence among young people is of concern. The premature prevalence of diabetes among young people results in the long involvement of patients with the diseases and, consecutively, more chronic complications and lower quality of life for patients [5]. Several key factors, including overweight and obesity, malnutrition or excessive nutrition, socioeconomic factors, low physical activity, family history, female gender and polycystic ovarian syndrome, and nonalcoholic fatty liver, contribute to the progress and prevalence of diabetes type 2 [6]. Young people suffering from diabetes could suffer from numerous complications, such as neuropathy, retinopathy, reduced fertility, increased cognitive and psychological disorders such as depression, small vascular complications, etc. [7–9], according to the epidemiological principles and the early prevalence of type 2 diabetes in them [6, 10, 11]. According to the instructions published to treat diabetes, controlling blood sugar is of paramount importance to reduce chronic and severe complications. Lifestyle modification is also among the priorities. Besides, pharmaceutical treatment and even approved surgical treatments are also quite important when the aforementioned measures are ineffective [12]. Family history of diabetes is a strong diabetes risk indicator, and those with a family history of diabetes in their first-degree families are three times more likely to suffer from diabetes type 2 according to the studies [13, 14]. A family history of diabetes is associated with reduced risky behaviors and awareness of the risk, which has made it a useful screening tool to prevent and diagnose diabetes [14]. Thus, one early prevention strategy is to concentrate on the first-degree relatives of diabetes type 2 patients [15], and the American Diabetes Association has also recommended screening the first-degree relatives of these patients and modify their lifestyles [16]. Education is the foundation of early diabetes prevention in these people. Emphasis on a healthy lifestyle through training programs in educational centers and using social media channels could be effective in this regard [17]. Among various approaches used to modify these people’s lifestyles and prevent diabetes, Cognitive-Behavioral Therapy (CBT) is of great importance due to its emphasis on the individual’s behavioral beliefs and self-regulation. The CBT approach is not a specific approach and rather includes learning various behaviors aiming to focus on the goal [4]. CBTs are effective in the establishment and increase of powers such as the decision-making power, creating motivation, positive interaction with others, accepting responsibility, cheerfulness, self-esteem, self-regulation, problem-solving, self-adequacy, quality of life, and reducing depression and anxiety [18]. These techniques use consultation and problem-solving components, and the patient participates in finding and solving problems that increase their adjustment to the circumstances and increase control, self-care, and awareness of their current situation. Besides, correct behaviors are reinforced and improper behaviors are repressed through self-regulation in this approach [19]. With the recent advancement of technology, the use of Internet-based cognitive behavioral therapy (ICBT (encompassing the use of websites, applications, social media, etc. has attracted great attention in the clinical and health improvement fields. It is used to treat various diseases such as a wide range of psychological disorders [20], chronic diseases [21], sleeping disorders [22], Post-traumatic stress disorder(PTSD), and the problems of patients under intensive care [23]. This method is also used to prevent some issues such as postpartum anxiety, stress, and suicide [24–26]. Studies have revealed that the use of ICBT is more cost-effective than traditional methods. The increased costs following the progress of the disease, lack of follow-ups, and insufficient information are among the weaknesses of the traditional treatment [27, 28] while reduced disease symptoms, improved performance, user satisfaction, and adherence of the patient to the treatment are the advantages of ICBT [29]. Besides, ICBT helps people develop a better understanding of their current situation so that they seek prevention and treatment [30]. The ability of mobile applications to deliver self-care and health information directly to patients has paved a new way in the field of improving health communication and support systems for patients, and its use is on the rise [31, 32]. Thus, the present study sought to determine the impact of CBT on blood sugar levels and HbA1c of relatives of type 2 diabetes patients.

Main objective

Determining the Effect of a Cognitive-Behavioral Program based on an Interactive Application on Serum Glucose Levels and HbA1C of Family members of Patients with Type 2 Diabetes.

Hypotheses

Cognitive-behavioral program affects serum glucose levels.

Cognitive-behavioral program affects HbA1C levels.

Materials and methods

Design

This randomized clinical trial(IRCT20111203008286N10), will conduct on families of diabetic patients referred to the Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran.

Intervention

According to the list of patients with diabetes who referred to the diabetes clinics, phone calls are first made to invite them to introduce one of their family members with the following criteria: being in the age group 30–60 years, no diabetes or cardiovascular history, no pregnancy or lactation, ability to perform physical activities (running), ability to speak Farsi, no mental disorder, no cognitive disorder such as Dementia and Alzheimer, no type 2 Diabetes history, no use of anti-diabetic and anti-obesity drugs, body mass index (BMI) < 35, and willingness to participate in the study. Then, the person was invited to the diabetes clinic (within a specified week) for a visit to measure the patient’s waist, blood pressure, and blood sugar. In cases of waist size of 89 ≥ cm for males and 91 cm for females, the blood sugar of ≥ 100 mg/dL, and systolic and diastolic blood pressures of ≥ 130 and 85 mmHg, respectively, the patients are referred to the clinic for experiments after 12 h of fasting (according to a written invitation containing the date, time, and place of reference to the experiments.

In the laboratory, 10 cc of the fasting blood sample taken for total cholesterol, triglyceride, FBS, GTT, HDL-c, LDL-c, and HbA1c tests. After obtaining the results, if the person has three out of five criteria of the American Heart Association (AHA) for metabolic syndrome, they will be selected for the study. Since the list of subjects is clear, simple random sampling used for the random selection of samples. For this purpose, informed consent forms are given to eligible subjects who receive numbers, which are then given to SPSS, and the software randomly assigned the participants into different groups. Then, both groups complete the International Physical Activity Questionnaire (IPAC), Adolescence Food Habit Checklist (AFHC), and Glover-Nilsson Smoking Behavioral Questionnaire (GN-SBQ).

For the participants in the intervention group, a lifestyle change package will prepare based on the CBP after reviewing the texts and interviews with experts. The subjects received the package as an educational application in eight sessions of 45 min in 8 weeks. The participants has to examine the application and exercises that were sent to improve their behavior. At the end of each week, the participants should send the exercises to the researcher through social media(What’s app) and receive feedback. Over the week, messages will send through social media regarding the use of the application (The content of the relevant application is finalized after the content validity. It is then given to an expert in the field to build the application. The existing application will be provided to ten participants who are not among the research samples in order to identify possible disorders and pilot. Possible bugs will be fixed.) and the needed guidance for the participants in the intervention group. These messages continued until the end of the 12th month. To prevent the contamination of the control group, passwords are set for each application to be installed only once. After setting a password, another existing password will enter each application. The duration will record each time that the person opens the application. Moreover, each session has a password, and the password for the next week will be send at the end of the assignments.

After 6 and 12 months of the intervention, the subject is monitored in terms of abdominal obesity, total cholesterol level, triglyceride, LDL-c, HDL-c, smoking, HbA1C, fasting blood sugar, OGTT, and blood pressure. IPAC, AFHC, and GN-SBQ questioners will be completed by the participants. In the control group, the participants receive information through media or society, but they receive no information from the researcher. After 6 and 12 months, the participants will be monitored in terms of abdominal obesity, total cholesterol level, triglyceride, LDL-c, HDL-c, smoking, HbA1C, fasting blood sugar. The IPAC, AFHC, and GN-SBQ questioners are also completed by the participants. It should be noted that the content of the session will be given to the participants in the control group after the study.

ADA and AHA criteria

According to the AHA protocol, if a person has three cases out of the following cases, they are exposed to the metabolic syndrome:

• Large waist — A waistline that measures at least 35 inches (89 cm) for women and 40 inches (102 cm) for men.

(in this section, however, waist circumference is considered to be > 89 cm in men and > 91 cm in women as abdominal obesity according to the national standards) [33].

• High triglyceride level — 150 milligrams per deciliter (mg/dL), 1.7 millimoles per liter (mmol/L), or a higher level of this type of fat found in the blood.

• Reduced “good” or HDL cholesterol — Less than 40 mg/dL (1.04 mmol/L) in men or less than 50 mg/dL (1.3 mmol/L) in women of high-density lipoprotein (HDL) cholesterol.

• Increased blood pressure — 130/85 millimeters of mercury (mm Hg) or higher.

• Elevated fasting blood sugar — 100 mg/dL (5.6 mmol/L) or higher [34, 35].

According to the American Diabetes Association (ADA) (2019), people who have one of the following conditions are diagnosed with prediabetes:

• FPG 100 mg/dl (5.6 mmol) to 125 mg/dl (6.9 mmol).

• 2-h PG during 75-g OGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (IGT).

• A1C 5.7–6.4% (39–47 mmol/mol) [36].

Exclusion criteria

• Unwillingness to continue the study.

• Hospitalization during the study.

• Glucose > 7 mmol /L(after measuring blood sugar twice, 12 h apart).

• Taking anti-diabetic medication during the study.

Sample size

A pilot trial can be used to obtain an estimate of the standard deviation, which could then be used to anticipate what may be observed in the main trial. The Upper Confidence Limit (UCL) approach are used in this study [37]. After the evaluation of all recognize eligible participants in our research, a code will be assigned to each participant (only the principal investigator is aware of the code assigned to each participant). Then, a stratified simple random allocation by a ratio of 1:1 will be used to the participants’ codes in intervention and control groups using an automated assignment system (the random assign of SPSS package). A centralized or third-party assignment will apply for unpredictable assignment sequences and allocation concealment. In other words, an external party will not involve in the other part of the clinical trial will be considered for the generation of an allocation frame. Due to the nature of the study, all participants enter the study together after a random allocation, and there is no risk of concealment violation by the executive team of the project.

The variance will reduce using a match stratified sampling in terms of age groups (30–44 and 45–60 years old), sex (male and female), and BMI groups (25-29.99 and 30 + kg/m²). According to this stratification, there are eight strata, and simple random allocation will be performed in each stratum to allocate the participants into control or intervention groups.

Before the allocation, only one eligible subject for participation will select from each family to decrease the contamination of the next allocated group. After the allocation, the recall days for training and evaluation will be different in each group (on even and odd days for the intervention and control groups, respectively) (Flowchart 1).

Chart 1.

Schematic diagram of the study process

The content of CBP sessions

The CBP is based on self-regulation theory and includes two main components of the motivational interview and problem-solving skills. Indeed, the motivational interview aims to enhance positive behaviors, and problem-solving skill corrects a problem. Moreover, the person tries to find and solve the problem in this method. In this study, educational content will be given to the participants as an interactional application. It will be explained that they should send reflection files related to each session, and the researcher would then provide them with feedback [38].

Session 1: Introduction including the importance of lifestyle and the affecting factors, the definition and importance of preventing metabolic syndrome and pre-diabetes, methods to improve lifestyle, and explanation of the CBP.

Sessions 2 and 3: including feedback of the previous session and answering questions, expressing the components affecting metabolic syndrome and pre-diabetes, responsibility in personal and family health, the role of nutrition and reducing fat in meals, reducing carbohydrate intake, giving the motivation to modify eating habits, writing down feelings, attitudes and problems, rethinking and sending to the researcher, and giving feedback from the researcher to the client.

Session 4: reviewing feedback from the previous session and answering questions, the role of physical activity, calculating BMI, defining optimal weight, motivating to improve physical activity, writing emotions, attitudes and problems, rethinking and sending to the researcher, giving feedback from the researcher to the participant.

Session 5: reviewing feedback from the previous session and answering questions, quitting smoking, improving interpersonal relationships, personal spiritual growth, motivating to quit smoking, writing down one’s feelings, attitudes and problems, rethinking and sending to the researcher, giving feedback from the researcher to the participant.

Session 6: reviewing feedback from the previous session and answering questions, methods to monitor and control blood pressure, factors affecting blood pressure, the role of nutrition in controlling blood pressure, motivating to monitor blood pressure, writing down emotions, attitudes, and problems, rethinking and sending to the researcher, giving feedback from the researcher to the participant.

Session 7: Overview of previous session feedbacks, stress management approach, anger management, and mental imagery, self-esteem and self-concept, relaxation training, motivating to control anger and stress, writing emotions, attitudes, and problems, rethinking and sending to the researcher, giving feedback from the researcher to the participant.

Session 8: Overview of feedback from previous sessions, answers to questions, and overview of sessions.

The content of CBP sessions was prepared after reviewing texts and interviews with people, nutritionists, nurses, psychologists, sport medicine specialists, and others, and then approved by other experts to determine the content validity. Moreover, this educational content was prepared as an application the content of which will be prepared by an expert team including a programmer and a graphic designer, and then is given to 10 people as the pilot to solve its potential problems.

In screening, the waist circumference will be measured between the inferior edge of the rib, and the iliac crest (the narrowest area) will be measured at the end of the expiration according to NHENSE (National Health and Nutrition Examination Survey Standard) protocol. The hip circumference will be measured from the large trochanter with the underwear using a tape measure (accuracy of 0.5 cm). Weight and height are also measured using standard measurement tools while the individual is not wearing shoes and is wearing lightweight clothing. The weight will be measured by the calibrated weight (0.1 Kg) and the height will be measured with a tape measure (accuracy of 0.5 cm). Then, BMI will be obtained by dividing the weight (kg) by the square of height (m²). According to the National Institute of Health (NIH), the natural BMI will be defined as 25, followed by overweight as 25–29 and obesity as ≥ 30 kg/m².

According to the Eighth Joint National Committee (JNC 8), the participants’ blood pressures are measured under stress after sitting for 10 min using a mercury barometer and an arm strap with the proper size. The barometer cuff will be wrapped on the right arm of the patient while the arm was in line with the heart, and the pressure exceeded 30 mmHg when the radial pulse sound is turned off. In the first phase of Korotkoff, the first sound that is heard is the systolic blood pressure and then the diastolic blood pressure is specified in the fifth phase with the disappearance of this sound. The cuff discharge speed varied between 2 and 3 mmHg per second while measuring the diastolic blood pressure and the systolic blood pressure. The blood pressure was measured two times in a 30 min interval, and the mean of these two pressures will be recorded as the person’s blood pressure.

Blood sugar will be measured by an ACCU-check glucose meter (active).

In the laboratory, total cholesterol, triglyceride, fasting blood sugar, GTT, HDL-c, and LDL-c tests are determined based on the auto analysis approach with HbA1c and Pars Azmun kits using high-performance liquid chromatography (HPLC), and blood samples were prepared afterward.

During the study, the participants with the systolic pressure of 160 mmHg and hypercholesterolemia above 8 mmol/L will be referred to a doctor. However, these people will be remained in the study, but if a participant had a glucose level above 7 mmol/L (after measuring blood sugar again), they will be referred to the doctor and excluded from the study.

Outcome

The main outcomes of the study are the serum glucose level and HbA1C. The secondary outcomes include total cholesterol level, triglyceride level, LDL level, HDL level, waist changes, MI changes, changes in eating habits, physical activity, smoking cessation, and blood pressure level changes.

Data analysis

Collected data will be analyzed using descriptive and analytical statistics. First, the normal distribution of the variables will be verified using the Shapiro test. When the variables had a normal or near to normal distribution, repeated measure Analysis of Variance (ANOVA) will be used for Parametric Statistical Tests.

The means of the two groups will be compared using UNIANOVA and MANOVA. Parametric tests, such as Kruskal–Wallis and Friedman, will be used when data distribution is not normal. Intention to treat (ITT) and sensitivity analysis will be carried out for loss to follow up.

Ethical consideration

• Obtaining written permission from the ethics committee.

• Introducing the researcher to the research community and explaining the study objectives and methods, and obtaining informed consent.

• Reassuring the research community on confidentiality of their information.

• Maintaining anonymity at all stages of data collection, analysis, and reporting results.

• Announcing the summary of the study results to the research community and relevant officials.

Questioners

Adolescence food habit checklist (AFHC)

The AFHC should provide a useful tool for the examination of healthy eating behaviors in adolescents. In particular, the orientation of the AFHC towards situations, in which adolescents are likely to have a degree of personal choice in their eating behavior, gives it an advantage over standard food frequency-type questionnaires, which may be much influenced by social circumstances and the decision-making of others. The AFHC measures active investment on the part of the adolescent in their diet, hence, it may be of value in examining the underlying cognitions, attitudes, and circumstances that lead to involvement in healthy eating.

This questioner has 23 items. Participants should respond to ‘true’, ‘false’,

or ‘not applicable to me’ with regard to whether they usually followed specific dietary practices. These practices included the purchase, preparation, and consumption of specific foods, as well as snacking habits. Items referred to both healthy and unhealthy behaviors. Participants were also asked to add their other regular actions to make their diet healthier. This questionnaire was localized by Feizi in a study entitled “Localization and evaluation of validity and reliability of food habits and preferences questionnaires in the Iranian adolescent and adult community.“The study “The relationship between physical activity and nutritional behavior in female adolescents in Bushehr in 1398” was also cited.

Scoring of AFHC

One point is given for each healthy response. The final score should be adjusted for “not applicable and missing responses using the formula:

AFHC Score = No. of “health” response × (23/No. of completed items). Internal reliability of the AFHC was high (Cronbach’s α = 0.82) [39].

International physical activity questionnaire (IPAQ)

The IPAQ is appropriate for adults between 15 and 69 years of age and is mainly used for population surveillance of physical activity levels. This questionnaire comprises a set of four questionnaires. Long (five activity domains asked independently) and short (four generic items) versions are available for use by either telephone or self-administered methods. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.

A standard questionnaire includes seven questions that aim to measure physical activity. In this questionnaire, questions 1 and 2 are related to the number of days and the amount of severe physical activities, questions 3 and 4 belong to the number of days and the amount of moderate physical activities, questions 5 and 6 are about the number of days and the amount of light physical activities, and question 7 concerns the sitting rate of the participants during the last 7 days [40]. In the study “The relationship between physical activity and nutritional behavior in female adolescents in Bushehr in 1398” has been taught. Also in the study “The effect of cardiac rehabilitation on heart rate control and quality of life in patients with chronic atrial fibrillation” has been used. It has been validated by Ali Vashghani Farahani under the title “The Persian, last 7-day, long form of the International Physical Activity Questionnaire: translation and validation study”.

Glover–nilsson smoking behavioral questionnaire (GN-SBQ)

The GN-SBQ uses 11 items scored 0–4 to assess the cognitive, social, and behavioral effects associated with tobacco dependence including associating smoking with daily activities and the use of tobacco to meet certain needs. It has good internal consistency (a- = 0.82) and test-retest reliability (r = 0.86). The behavior dependence was scored as < 12 (mild), 12–22 (moderate), 23–33 (strong), and > 33 (very strong) [41]. In the present study, it will be valid and reliable.

Discussion

Based on the outcomes of this study, it can be viable to take steps to alternate one’s lifestyle with the help of software primarily based on CBPs. The cell software is to be given to everyone at any time and place, doubles the significance of its application. It provides greater powerful schooling for the person in a relaxed and stress-free environment, which will increase the effectiveness of the schooling whilst the character feels the want and is prepared to simply accept the information. Also, primarily based totally on the sharing of structural and person getting to know theories and emphasis on getting to know, the opportunity of practice, ease of controlling getting to know speed, no stress, growing important questioning power, the use of special getting to know styles (visual, auditory, and tactile) all These objects may be visible in an academic software. This encourages the character to apply this software, and the character is recommended to view and receive the schooling objects several times. In this regard, with the growing development of the generation and its access to diverse fields, in addition to the growing increase of telehealth and the opportunity of its use within the fields of prevention-diagnosis-treatment.

Probably due to the follow-up periods, we experienced drops out and this issue was considered in determining the sample size, and ITT will be done at the end of the study. Besides, it will be attempted to contact the participants and encourage them to continue the study. Furthermore, the follow-up duration short (one year) is this study.

Declarations

Conflict of interest

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.