Brief Cognitive Behavioral Therapy for Adherence and Depression in Patients With Type 2 Diabetes in an Urban Primary Care Facility: Randomized Controlled Trial
Phase: NA
Conditions: Type 2 Diabetes, Depression
Sponsor: Cairo University

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Brief Cognitive Behavioral Therapy for Adherence and Depression in Patients 
with Type 2 Diabetes in an Urban Primary Care Facility: study protocol for a 
single-blind parallel-group randomized controlled trial 
 
 
 
Statistical Analysis & Data Management Plan  
 
 
 
 
 
 
 
 
 
 
 
 
NCT04214600  
Clinical Trial Code: D-49-2019 
Sponsor: Research Ethics Committee, Faculty of Medicine, Cairo University,  
 
 
 
Department of public health and community medicine, 
Faculty of Medicine, Cairo University,  
Cairo, Egypt 
17 Sept 2020 

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Table of Contents 
 
1 Background .................................................................................................................. 4 
1.1 Study Objectives .................................................................................................... 4 
1.2 Study Design .......................................................................................................... 4 
2   Analysis Populations .................................................................................................. 5 
3 Study Centre ................................................................................................................ 5 
4 Data Collection Tools ................................................................................................... 6 
4.1 Demographic .......................................................................................................... 6 
4.2 Diabetes History and Health Behavior Questionnaire ............................................ 6 
4.3 Measure Treatment Adherence (MTA) .................................................................. 6 
4.4 Beck’s Depression Inventory (BDI) ........................................................................ 6 
4.5 Structured Clinical Interview for Diagnostic and Statistical Manual of Mental 
Disorders, 4th Edition (SCID-IV) .................................................................................. 6 
4.6 Anthropometric and Biochemical Measures ........................................................... 7 
5 Intervention .................................................................................................................. 8 
5.1 Diabetes Education Message ................................................................................ 8 
5.2 Cognitive Behavioral Therapy Program ................................................................. 8 
6 Post-intervention ........................................................................................................ 10 
7 Treatment of Missing Values and Outliers .................................................................. 11 
8 Analysis Variables ...................................................................................................... 12 
8.1 Demographics ...................................................................................................... 12 
8.2 Baseline Characteristics ....................................................................................... 12 
8.2.1 Psychosocial scores ...................................................................................... 12 
8.2.2 Anthropometric measurements ...................................................................... 12 
8.2.3 Laboratory tests ............................................................................................. 12 
8.2.4 Medical Data .................................................................................................. 12 
8.2.5 Habits and lifestyle ......................................................................................... 13 
8.2.6 Adherence to treatment ................................................................................. 13 
9 Statistical Analysis...................................................................................................... 14 
9.1 Software ............................................................................................................... 14 
9.2 Analysis of Outcomes .......................................................................................... 14 
9.2.1 primary analysis ............................................................................................. 14 

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9.2.2 Secondary analysis ........................................................................................ 15 
10 Monitoring ................................................................................................................ 17 
10.1 Data Monitoring .................................................................................................. 17 
10.2 Harms ................................................................................................................ 17 
10.3 Auditing .............................................................................................................. 17 
11 Ethics and dissemination .......................................................................................... 18 
11.1 Research Ethics Approval .................................................................................. 18 
11.2 Protocol Amendment.......................................................................................... 18 
11.3 Confidentiality .................................................................................................... 18 
11.4 Access to Data ................................................................................................... 18 
11.5 Ancillary and Post-Trial Care ............................................................................. 18 
12 Dissemination policy ................................................................................................. 19 
12.1 An Interim Period of Analysis and Documentation of Study Results .................. 19 
12.2 Reporting of Study Results ................................................................................ 19 
12.3 Status of the Trial ............................................................................................... 19 
13 References ............................................................................................................... 20 
14 Appendices ................................................................ Error! Bookmark not defined. 
14.1 Appendix: Questionnaire ...................................... Error! Bookmark not defined. 
14.2 Appendix: Health Education Message ................. Error! Bookmark not defined. 
 
 
 
 
 
 
 
 
 
 
 
 

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1 Background  
 
1.1 Study Objectives  
 
Primary objective 
To assess the efficacy of the diabetes-specific Cognitive Behavioral Therapy (CBT) 
versus control in helping patients with Type 2 diabetes (T2D) and depressive symptoms 
to achieve glycemic control. Primary endpoint: change of glycated hemoglobin A1c (Hb 
A1c) level three months after the intervention.  
 
Secondary objective  
Estimate the efficacy of CBT in improving depressive symptoms among T2D patients. 
Secondary endpoint: change of depression score on Beck’s Depression Index (BDI). 
 
1.2 Study Design  
Prospective, randomized, parallel group, two-arm controlled trial comparing CBT vs 
control groups after two months of CBT intervention. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2   Analysis Populations  
  
The study population is defined by the following key inclusion and exclusion criteria:  
 
Key inclusion criteria  
 
 - Uncontrolled type 2 diabetes mellitus (HbA1c ≥6.5%) 
 - Mild mood disturbance to Moderate depression (BDI) 
 - 35 to 80 years of age 
 - Able to give informed consent and understand given information.  
 
Key exclusion criteria   
 
- Type I diabetes  
- Psychiatric disorders other than depression or personality disorders including 
schizophrenia, bipolar disorder, and substance or alcohol abuse.  
- Depressed patients on treatment for depression  
- Suicidal patients and those diagnosed with major depressive disorder will be referred 
to a psychiatrist. 
 
3 Study Centre 
 
Al-Agouza Family Medicine Center (AFMC) is a primary healthcare center in Giza, 
Egypt. The AFMC patient registry (database) currently has more than 1370 family 
medical records. It has been maintained since 2011. It has been estimated at 11% of 
patients in the database are diabetics and between 48-96 new diabetic patients are 
seen each year. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4 Data Collection Tools  
 
A structured questionnaire will be used to collect data from the study participants. The 
questionnaire includes the following: 
 
4.1 Demographic (age, residence, gender, marital, status, education level, occupation). 
 
4.2 Diabetes History and Health Behavior Questionnaire   
   
4.3 Measure Treatment Adherence (MTA) 
To assess patients’ adherence to diabetes medications, the Measure Treatment 
Adherence (MTA) modified scale will be used (Morisky et al. 1986; Delgado & Lima 
2011). Several studies had validated the scale (Lopes et al. 2008; Shams & Barakat 
2010). MTA Scale consisted of six questions and allowed answers from “always” to 
“never,” with scores ranging from 1 to 4 points. The highest values indicated the highest 
level of adherence to treatment. Adherence score will be considered as follows: 
- More than 75%- good adherence 
- Between 50%-75%- poor/partial adherence 
- Less than 50%- non-adherence  
 
4.4 Beck’s Depression Inventory (BDI) 
Moreover, depression will be assessed using BDI (Lustman, Clouse, Griffith, Carney, & 
Freedland, 1997) as recommended by the research psychiatrist. BDI is a 21-question 
multiple-choice self-report inventory, used for measuring the severity of depression. A 
value of 0 to 3 will be assigned for each answer and then the total score will be 
compared to a key to determine the depression's severity. The standard cut-off scores 
will be 
 as follows: 
- 1-10 These ups and downs are considered normal  
- 11-16 Mild mood disturbance  
- 17-20 Borderline clinical depression  
- 21-30 Moderate depression  
- 31-40 Severe depression  
- over 40 Extreme depression 
 
4.5 Structured Clinical Interview for Diagnostic and Statistical Manual of Mental 
Disorders, 4th Edition (SCID-IV)  
The SCID-IV (Glasofer et al. 2015) will be used to diagnose patients with mood 
disorders and exclude other psychiatric morbidities.  
 

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4.6 Anthropometric and Biochemical Measures 
The anthropometric measurements will be performed. The weight in kg and height in cm 
will be measured using the UGM-200 health scale with barefoot patients, wearing light 
clothes, and looking at the horizon. The waist circumference in centimeters will be 
measured on bare skin, mid-distance between the bottom of the rib cage and the top of 
the iliac crest using an inelastic tape. The BMI will be calculated by dividing the weight 
by the height squared (BMI= weight in kg/height in cm2) (Cashin & Oot 2018).  
To assess diabetes control, Fasting Plasma Glucose (FPG), 2-hour Plasma Glucose (2-
h PG), and HbA1c will be performed at the AFMC clinical laboratory. Subsequently, 
participants will be randomized to control and treatment groups if they met our inclusion 
criteria. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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5 Intervention  
5.1 Diabetes Education Message  
All eligible patients will be offered a structured diabetes education by a trained educator 
as an update to ensure adequate diabetes knowledge in all trial participants. A one-
session message for 30-40 minutes and covered the following: 
- Pathophysiology of DM 
- Early detection of diabetes symptoms 
- Risk and predisposing factors  
- Recognition of diabetes complications 
- Self-care including diabetes-relevant behavior (e.g., nutrition, physical activity, foot 
care) 
- Monitoring and treatment of diabetes      
5.2 Cognitive Behavioral Therapy Program  
The treatment group will receive four CBT sessions twice a month for two months. The 
control group will be scheduled the same number of visits as a follow up for DM. 
Patients in the CBT intervention group (Safren & Gonzalez 2007) received four 
educational sessions for 30-45 minutes once every two weeks during patients’ regular 
follow up visits. The visits will be scheduled depending on the patient’s availability. The 
sessions will be delivered by a trained physician. They will be on one to one basis and 
will be held at the AFMC outpatient clinic. The sessions included: 
Session 1: Dealing with thoughts of sadness and depression 
Session 2: Dealing with thoughts of anxiety and stress 
Session 3: Dealing with anger  
Session 4: Enhancement of coping and problem-solving skills  
 
During the sessions, each participant worked with the healthcare provider to:  
STEP 1: Identify thoughts and determine their effect on actions and feelings. Some 
examples include: 
a. 
Thoughts 
o 
“What have I done to deserve this?” 
o 
“This illness is some kind of punishment for bad things I have done” 
o 
“I’ll never ﬁnd anyone who will love me.” 
 
b. 
Feelings  

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o 
“I’m a failure because I have diabetes” 
o 
“I am unlovable because of this illness and how I am managing it” 
c. 
Actions  
o 
“There is nothing I can do to stop diabetes complications” 
o 
“There is no way I can manage everything I need to for diabetes” 
o 
 Not meeting anyone, spending the weekends alone at home 
 
STEP 2: Challenge Thoughts, analyze each thought to work out if it has been realistic or 
unhelpful. This can be achieved by asking questions such as: 
o 
What is the evidence for and against this thought?  
o 
Is thinking this way helping me? 
o 
Is there really nothing you can do? 
 
STEP 3: Think of an alternative, balanced thought the physician will helpe patients 
change unhelpful thoughts and behaviors by teaching them some skills during they 
could apply daily. “I may not be able to control whether I develop complications, but I 
can feel in control of trying my best to keep healthy” 
o 
“The research shows that those who test their blood are healthier and less 
likely to develop long term complications” 
Patients will be encouraged to practice these changes in their daily life and discuss how 
they got on during the next session. This should help patients manage daily life 
problems and stop them from having a negative impact on their life. Patients will be 
encouraged to set a diabetes-specific goal in order to improve their glycemic control 
such as weight loss or HbA1c target values and try to achieve it at the end of the 
sessions.  
Adherence to CBT has been determined by the number of CBT-sessions attended by 
participants and will be defined as follows: 
- Adherent participation- 3-4 sessions of CBT  
- Partially non-adherent participation- 1–2 sessions of CBT  
- Non-adherent 
- No participation in any session of CBT 
 
 
 
 
 
 

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6 Post-intervention  
In the last visit three months later, all participants will be reassessed for depression 
using BDI and diabetes compliance using the MTA modified scale. All required labs 
(FPS, 2-h PG, and HbA1c) will be reperformed. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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7 Treatment of Missing Values and Outliers  
Appropriate methods will be employed on an individual basis for the missing values and 
variables normalization. The primary analyses for HbA1c and the BDI scores will be 
repeated after employing the last observation carried forward method (LOCF). The 
multiple imputation method will be employed when more than 10% but less than 40% of 
the values will be missing (Pedersen et al., 2017). If outliers will be apparent to bias the 
analysis, they will be set to missing.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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8 Analysis Variables 
  
8.1 Demographics 
The demographics age (35-39/40-45/46-50/51-55/56-60/>60years), gender 
(male/female), marital status (single/married/divorced/widowed), education level 
(illiterate/read & write/primary/preparatory/secondary/university), employment status (full 
time/part time/per diem/unemployed/retired/housewife), and occupation (no 
work/unskilled worker/manual skilled worker/managerial work/semi-
professional(clerk)/professional) will be presented by number and percentage. 
Exploratory p-values of the Chi-Square test between treatment groups will be displayed. 
8.2 Baseline Characteristics  
The following variables will be included: 
8.2.1 Psychosocial scores  
Depressive symptoms using the BDI Scoring will be presented by appropriate 
descriptive statistics (mean, standard deviation, median, and interquartile range (IQA). 
Exploratory p-values of the t-test between treatment groups will be calculated.  
8.2.2 Anthropometric measurements  
Anthropometric measurements including weight [kg], height [cm], BMI [kg/cm2], and 
waist circumference [cm] will be presented by appropriate descriptive statistics (mean, 
standard deviation, median, and interquartile range (IQA). Exploratory p-values of the t-
test between treatment groups will be calculated.  
8.2.3 Laboratory tests  
Laboratory tests including FPG [mg/dl], 2h PG [mg/dl], & HbA1c [%] will be presented 
by appropriate descriptive statistics (mean, standard deviation, median, and interquartile 
range (IQA). Exploratory p-values of the t-test between treatment groups will be 
calculated.  
8.2.4 Medical Data  
The medical history of DM including age of onset [years], duration of DM [years], & 
family history of DM (non/father/mother/brothers/sisters/uncles/aunts) will be identified. 
The number of comorbidities and diabetes side effects will be recorded. The type of 
comorbidities (hypertension/dyslipidemia/gout/heart disease/others) and the type of 
diabetes side effects (neuropathy/nephropathy/retinopathy) will be identified. Medical 
data will be summarized by the appropriate descriptive statistics no, percentage, mean, 
standard deviation, median, interquartile range (IQA), minimum, and maximum.  

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8.2.5 Habits and lifestyle 
The frequency of blood monitoring (every day/every week/once a month/every other 
month/few times a year); the mechanism of blood glucose monitoring (home/clinical 
laboratory); frequency of visiting doctor for follow up (twice a month/every month/every 
other month/few times a year); diet control (yes/no/sometimes); carbohydrates craving 
(always/many times/sometimes/never); the pattern of physical activity 
(yes/no/sometimes) will be identified. The data will be presented by number and 
percentage. Exploratory p-values of the Chi-Square test between treatment groups will 
be displayed. 
8.2.6 Adherence to treatment 
Type of diabetes medication (table/insulin); assessment for adherence based on MTA 
scale (%); and reasons for non-adherence (ineffective/side 
effects/forgetful/expensive/better without treatment) will be recorded. Adherence data 
will be presented by appropriate descriptive statistics (mean, standard deviation, 
median, and interquartile range (IQA). Exploratory p-values of the t-test and chi-square 
between treatment groups will be calculated.  
The number of study CBT sessions and visited attended by the study groups will be 
recorded and presented as number and percentage. 
 
 
 
 
 
 
 
 
 
 
 
 

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9 Statistical Analysis 
The analysis will be conducted according to the Consolidated Standards of Reporting 
Trials guideline (CONSORT). An academic statistician blinded to study groups 
conducted the study statistical analysis. Quantitative data will be examined for normality 
distribution using the Shapiro-Wilk’s test (p>0.05) (Shapiro & Wilk 1965; Razali & Bee 
Wah 2011) test. Results of p<0.05 will be considered significant indicating non-normal 
distribution. A parametric Levene’s test will be used to verify the equality of variances in 
the samples (homogeneity of variance) (p>0.05) (Nordstokke, & Zumbo 2010; 
Nordstokke et al. 2011). 
Simple frequency distribution tables to provide a description for both groups will be 
generated. Quantitative variables will be summarized using. mean and standard 
deviation (SD) for normally distributed quantitative variables and median and 
interquartile ranges (IQR) for not normally distributed quantitative variables. While the 
number and percentage will be used to summarize qualitative variables. 
Exploratory p-values of the student two-tailed independent t-test and Chi-Square test 
between study groups will be used for baseline quantitative and qualitative variables, 
respectively. P-values will be reported to three decimal places with p-values less than 
0.001 reported as p < 0.001. We w used 2-sided p-values with alpha ≤ 0.05 level of 
significance. 
Two sets of analyses will be conducted corresponding to the study outcomes’ 
endpoints: 1) the CBT group demonstrated improvement of HbA1c level at the end of 
the sessions and 2) the CBT group demonstrated improvement of depression score on 
BDI versus the control group.  
9.1 Software 
Pre coded data will be entered on Microsoft office excel program for windows, 2010. 
Data will be transferred to the Statistical Package for Social Science Version 21 (SPSS- 
V 21). 
9.2 Analysis of Outcomes 
9.2.1 primary analysis  
The primary variable is the Hb A1c plasma level. 
The primary endpoint is the difference between Hb A1c level at baseline and three 
months later.  
The primary outcome is the change of Hb A1c, compared between the different 
treatment groups using an Analysis of Covariance (ANCOVA), the General Linear 
Modeling approach to compare the study groups. The HbA1c and BDI at baseline will 
serve as control variables. HbA1c and BDI values at baseline are the values obtained at 

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the first visit before the start of the intervention. If the HbA1c value at baseline is 
missing, the first HbA1c value obtained during the first subsequent visits will be used.  
The following hypothesis will be tested: 
H0: µCBT = µcontrol versus H1: µCBT ≠µcontrol  
Where µCBT and µcontrol are the expected mean values of the differences in HbA1c 
values belonging to the CBT and the control groups. The hypothesis will be tested on a 
2-sided p-value with alpha ≤ 0.05 level of significance. The results will be displayed by 
means of the p-value, standard deviation of unadjusted values, and 95%-confidence 
interval. For that, the assumption of homogeneity of regression slope will be examined 
by testing the interaction effect of the independent variable and the covariate. 
The secondary variable is the BDI score. 
The secondary endpoint is the difference between BDI at baseline and three months 
later.  
The secondary outcome is the change of BDI compared between the different study 
groups using an Analysis of Covariance (ANCOVA), the General Linear Modeling 
approach to compare the study groups. The HbA1c and BDI at baseline will serve as 
control variables. HbA1c and BDI values at baseline are the values obtained at the first 
visit before the start of the intervention. For that, the assumption of homogeneity of 
regression slope will be examined by testing the interaction effect of the independent 
variable and the covariate. 
The following hypothesis will be tested: 
H0: µCBT = µcontrol versus H1: µCBT ≠µcontrol  
Where µCBT and µcontrol are the expected mean values of the differences in the BDI score 
belonging to the CBT and the control groups. The hypothesis will be tested on a 2-sided 
p-value with alpha ≤ 0.05 level of significance. The results will be displayed by means of 
the p-value, standard deviation of unadjusted values, and 95%-confidence interval. For 
that, the assumption of homogeneity of regression slope will be examined by testing the 
interaction effect of the independent variable and the covariate. 
9.2.2 Secondary analysis 
The primary outcome change of glycemic control after adjustment for potential 
confounders will be further analyzed by ANCOVA with additional control variables. A 
correlation analysis will be performed with the age, sex, comorbidities, and diabetes 
side effects as potential control variables. 
The resulting p-values will be checked. If Pearson’s correlation coefficient has a p-value 
<.05, the control variable will be used to conduct further ANCOVA. The additional 

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ANCOVA will include the study groups, HbA1c baseline, and the selected control 
variables.  
The secondary outcome change of depression symptoms after adjustment for potential 
confounders will be further analyzed by ANCOVA with additional control variables. A 
correlation analysis will be performed with the age, sex, comorbidities, and diabetes 
side effects as potential control variables. 
The resulting p-values will be checked. If Pearson’s correlation coefficient has a p-value 
<.05, the control variable will be used to conduct further ANCOVA. The additional 
ANCOVA will include the study groups, BDI baseline, and the selected control variables.  
9.2.3 Subgroup analysis  
A subgroup analysis of the type of diabetes treatment will be conducted for the primary 
outcome. This will be done by including diabetes treatment type and study groups 
variables in the ANCOVA. 
The HbA1c values for the subgroup analysis will be displayed by descriptive statistics 
(n, mean, standard deviation, median, and interquartile-range (IQA)) and they will be 
compared by p-values of t-test. 
Descriptive statistics of demographic and baseline medical and psychosocial 
characteristics will be displayed by type of diabetes treatment. Exploratory p-values of t-
test and chi-square tests will be presented to examine differences between both 
subgroups. 
 
 
 
 
 
 
 
 
 
 
 
 
 

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10 Monitoring 
10.1 Data Monitoring 
The trial has a calculated sample size of 80. The intervention duration is short for two 
months. Accordingly, the study is expected to bear no to minimal risk. Thus, no data 
monitoring committee (DMC) will be needed.  
10.2 Harms  
An adverse event is defined by this study as any unfavorable medical occurrence in a 
subject that has a temporal relationship to the study intervention (CBT). All adverse 
events will be collected and recorded after the patients will be enrolled in the study. 
However, only serious adverse events that result in severe or permanent disability or 
prolonged hospitalization will be reported to the Research Ethical Committee (REC).  
There are no to minimal risks associated with the CBT program. The program targets 
depressive symptoms. However, like any medical treatment, the program may bear the 
risk that it will not work. In this case, patients may feel disappointed that their 
depression will deteriorate. However, such clinical deterioration is rare. (Morisky et al. 
1986; Delgado & Lima 2011). 
Potential side effects may include risks associated with blood withdrawal. There may be 
some minor discomfort or pain associated with collecting blood. Some participants may 
experience minor local bruising or brief lightheadedness. For that, blood specimens will 
be collected by trained and experienced lab technicians. Some patients might be slightly 
distressed by the rating scales. Thus, we will keep the collected information as minimal 
as possible and will be part of the clinical care. 
Possible benefits of the program include reduced depressive symptoms, distress, and 
impairment, and clinically significant remission of depressive symptoms. 
10.3 Auditing  
Regular team meetings will be conducted to address any difficulties experienced during 
the study especially those participants may be having difficulties and ways of best 
dealing with them. Serious adverse events will be reported to the REC at the Faculty of 
Medicine, Cairo University.  
 
 
 

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11 Ethics and dissemination   
11.1 Research Ethics Approval 
The study protocol, consent form, participant education, and recruitment materials both 
in local language and English versions have been reviewed and approved on December 
2018 before study implementation by the department of public health and community 
medicine; department of psychiatry; department of internal medicine at Elkasr Eleini 
Medical School, the REC at Cairo University; and the administrative office at Alagouza 
health district. 
11.2 Protocol Amendment 
Any modifications to the protocol which may impact the study conduct or may cause 
potential benefits or harm to the patient including changes of study objectives, design, 
procedure, target population, sample size, or significant administrative matters will 
require a formal amendment to the protocol. Such amendment will be agreed upon by 
the REC at Cairo University prior to implementation. Minor administrative changes of 
the protocol that have no effect on the study will only need the approval of the 
department of public health and community medicine and will be documented in a 
memorandum. The REC may be notified of such changes. 
11.3 Confidentiality 
All participant and study-related information including consents and questionnaires will 
be stored in a locked file cabinet in an area with limited access to the study site. All 
reports and administrative forms will be recognized by an identification (ID) number. 
Records that link participant ID numbers to other identifying information will be stored in 
a separate locked file in an area with limited access to keep participant confidentiality. 
All electronic databases will be password protected and stored on the AFMC computer 
and will be accessible to only study investigators approved by the REC. Data analysis 
will be performed at Cairo University.  
11.4 Access to Data 
The Project Principal Investigator will have access to all data set. the final data set will 
be available to the other team members at the end of the study. The final set will not 
include any identifier information to ensure participants’ confidentiality. 
11.5 Ancillary and Post-Trial Care 
Enrolled patients will be protected against negligent harm based on the standard of 
REC at Cairo University.   
 
 

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12 Dissemination policy 
12.1 An Interim Period of Analysis and Documentation of Study Results 
Every effort will be made to reduce the period between data collection and the release 
of the study results. We assume that around six to ten months will be needed to make a 
complete manuscript ready for publication. 
 12.2 Reporting of Study Results 
We will disseminate the study results to the study team members, patients, the public, 
and the medical and scientific community. 
Data will be shared no later than two years after one year of data collection. We will 
provide a complete data set via an appropriate data archive for dissemination purposes. 
12.3 Status of the Trial 
Currently, the trial is in the data analysis phase. Recruitment started in April 2019. We 
were able to screen 394 participants. Around 100 met our inclusion criteria and 
accepted to participate. We anticipate final follow-up data and publication to be ready by 
February 2021. 
 
 
 
 
 
 
 
 
 
 
 
 
 

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13 References  
 
Cashin, K., & Oot, L. (2018). Guide to Anthropometry: A Practical Tool for Program Planners, 
Managers, and Implementers | Food and Nutrition Technical Assistance III Project (FANTA). 
Retrieved from Food Nutr Tech Assist III Proj (FANTA)/FHI, 360, 93-115.: 
https://www.fantaproject.org/tools/anthropometry-guide 
Delgado, A. B., & Lima, M. (2011). Contributo para a validação concorrente de uma medida de 
adesão aos tratamentos. Psicologia, saúde & doenças, 2(2), 81-100.  
Glasofer, D., Brown, A., & Riegel, M. (2015). Structured Clinical Interview for DSM-IV (SCID). In 
D. Glasofer, A. Brown, & M. Riegel, Encyclopedia of Feeding and Eating Disorders (pp. 1-4). 
Springer Singapore. 
Lopes, N., Zanini, A., Casella-Filho, A., & Chagas, A. (2008). Metabolic syndrome patient 
compliance with drug treatment. Clinics (Sao Paulo, Brazil), 63(5), 573-80. 
Lustman, P., Clouse, R., Griffith, L., Carney, R., & Freedland, K. (1997). Screening for 
depression in diabetes using the beck depression inventory. Psychosomatic Medicine, 59(1), 
24-31. 
Morisky, D. E., Green, L. W., & Levine, D. M. (1986). Concurrent and predictive validity of a self-
reported measure of medication adherence. Medical care, 67-74. 
Nordstokke, D. W., & Zumbo, B. (2010). A New Nonparametric Levene Test for Equal. 
Variances Psicológica, 31(2), 401-430. 
Nordstokke, D. W., Zumbo, B. D., Cairns, S. L., & Saklofske, D. H. (2011). The operating 
characteristics of the nonparametric Levene test for equal variances with assessment and 
evaluation data. Practical Assessment, Research, and Evaluation, 16(1), 5. 
 
Pedersen, A., Mikkelsen, E., Cronin-Fenton, D., Kristensen, N., Pham, T., Pedersen, L., & 
Petersen, I. (2017). Missing data and multiple imputation in clinical epidemiological research. 
Clinical Epidemiology, 9, 157-166. 
Razali, N. M., & Wah, Y. B. (2011). Power comparisons of shapiro-wilk, kolmogorov-smirnov, 
lilliefors and anderson-darling tests. Journal of statistical modeling and analytics, 2(1), 21-33. 
Safren, S., Gonzalez, J., & Soroudi, N. (2007). Coping with chronic illness: a cognitive-
behavioral approach for adherence and depression therapist guide. Oxford University Press. 
Shams, M., & Barakat, E. (2010). Measuring the rate of therapeutic adherence among 
outpatients with T2DM in Egypt. Saudi Pharmaceutical Journal, 18(4), 225-232. 
Shapiro, S., & Wilk, M. (1965). An Analysis of Variance Test for Normality (Complete Samples). 
Biometrika, 52(3/4), 591.