IRCT | Comparison of cost-effectiveness, cost-utility, feasibility and the effect of intensive life style intervention based on an integrated behavioral model including two calorie-carbohydrate restricted diets and the combination of intermittent fasting diet with calorie-carbohydrate restriction on body composition and diabetes remission in patients with type 2 diabetes: a randomized controlled trial study

#	Registration date	Revision Id
2	2025-02-19, 1403/12/01	331076
1	2024-05-01, 1403/02/12	300402

Protocol summary

Study aim: Comparison of the percentage of remission and changes in average HbA1C, weight, and body composition indices, as primary outcomes in two dietary interventions, calorie-carbohydrate restricted (CCR) and the combination of intermittent fasting diet with calorie-carbohydrate restriction (IFCCR) and standard treatment group in patient with type 2 diabetes, at 3 and 6 months.
Design: Randomized, controlled clinical trial with three parallel groups with stratified permuted block randomization based on treatment groups will be done.
Settings and conduct: In this randomized controlled trial study, men and women aged 18-50 years with type 2 diabetes with duration of diabetes diagnosis less than 5 years will be selected. We then randomly assigned them to one of three study groups. In the first 3 months, the intervention will be a focused lifestyle behavior model including diet, physical activity and education and we will try to induce diabetes remission (primary outcome) in patient. In the second 3 months, the goal is to support patients' efforts to maintain weight loss and physical activity. For the purpose of blinding, all assessors will be kept unaware of subjects' allocation to study groups. Due to the nature of the lifestyle intervention under review, participants, intervention providers will be aware of the group allocation.
Participants/Inclusion and exclusion criteria: Inclusion criteria Men and women aged 18-50 years old with Less than 5 years duration of type 2 diabetes diagnosis Exclusion criteria Use of insulin, GLP-1 receptor agonist and sulfonylurea drugs
Intervention groups: First group: Calorie-Carbohydrate Restriction (CCR) group Second group: Intermittent Fasting with Calorie-Carbohydrate Restriction (IFCCR) group Third group: control
Main outcome variables: Diabetes remission percentage; Hemoglobin A1c; Body weight; Body fat mass; Fat Free Mass

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20240418061519N1

Registration date: 2024-05-01, 1403/02/12

Registration timing: prospective

Last update: 2024-05-01, 1403/02/12

Update count: 1
Registration date: 2024-05-01, 1403/02/12

Registrant information: Name

Negin Badrooj

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 4432 4043

Email address

badroojn@razi.tums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2024-05-21, 1403/03/01
Expected recruitment end date: 2024-11-21, 1403/09/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of cost-effectiveness, cost-utility, feasibility and the effect of intensive life style intervention based on an integrated behavioral model including two calorie-carbohydrate restricted diets and the combination of intermittent fasting diet with calorie-carbohydrate restriction on body composition and diabetes remission in patients with type 2 diabetes: a randomized controlled trial study

Public title: Effect of lifestyle intervention on type 2 diabetes remission
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Men and women aged 18-50 years old Less than 5 years duration of type 2 diabetes diagnosis Use of at least one blood glucose-lowering medication HbA1c more than 7.5% Body mass index (BMI) 27-40 kg/m2

Exclusion criteria:

Use of insulin Use of GLP-1 receptor agonist and sulfonylurea drugs Recent routine HbA1c ≥10% Weight loss of more than 5 kg within the last 6 months Renal dysfunction (eGFR <60 ml/min) Uncontrolled blood pressure (more than 160 mm Hg systolic or more than 100 mm Hg diastolic) Known cancer Heart disease Active gout Diagnosed eating disorder Patients with confirmed mental disorders Current treatment with anti-obesity drugs History of bariatric surgery Currently pregnant or breastfeeding, or planning to become pregnant in the next 12 months Substance abuse Night shift workers Inability to perform physical activities
Age: From 18 years old to 50 years old
Gender: Both

Phase

N/A

Groups that have been masked

Outcome assessor
Data analyser

Sample size

Target sample size: 120

Randomization (investigator's opinion)

Randomized

Randomization description

The purpose of randomization is to control the effect of all influencing variables on the results of the study and prevent interference between treatment groups. Randomization will be done and the Stratified Permuted Block Randomization method based on treatment groups using blocks of 3 and 6 through the link https://www.sealedenvelope.com/simple-randomiser/v1/lists. We will allocate participants to one of our three groups, calorie-carbohydrate restricted groups or the intermittent fasting with calorie-carbohydrate restriction group or to the guideline-based usual care group. In this randomization method, the strata are gender.

Blinding (investigator's opinion)

Single blinded

Blinding description

For purposes of blinding, all assessors will be kept unaware of subjects' allocation to study groups. Due to the nature of lifestyle interventions, participants and intervention providers will be aware of group allocation. However, the allocation remains hidden from the study statistician who is responsible for developing and implementing statistical analysis programs.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee of Tehran University of Medical Sciences

Street address

Tehran University of Medical Sciences, Pour Sina St, Qods St, Enghelab Ave, Tehran, Iran.

City

Tehran

Province

Tehran

Postal code

1461884513
Approval date: 2023-12-30, 1402/10/09
Ethics committee reference number: IR.TUMS.SHARIATI.REC.1402.128

Health conditions studied

1

Description of health condition studied: Type 2 diabetes
ICD-10 code: E11
ICD-10 code description: Type 2 diabetes mellitus

Primary outcomes

1

Description: Changes in mean Hemoglobin A1C
Timepoint: Hemoglobin A1C measurement at the beginning of the study, three and six months after the start of the intervention
Method of measurement: High-performance liquid chromatography

2

Description: Body weight
Timepoint: Body weight measurement at the beginning of the study, three and six months after the start of the intervention
Method of measurement: Bioelectrical impedance analysis (TANITA BC-418)

3

Description: Body Fat Mass
Timepoint: Body Fat Mass measurement at the beginning of the study, three and six months after the start of the intervention
Method of measurement: Bioelectrical impedance analysis (TANITA BC-418)

4

Description: Fat Free Mass
Timepoint: Fat Free Mass measurement at the beginning of the study, three and six months after the start of the intervention
Method of measurement: Bioelectrical impedance analysis (TANITA BC-418)

Secondary outcomes

1

Description: Fasting blood glucose
Timepoint: Fasting blood glucose measurement at the beginning of the study, three and six months after the start of the intervention
Method of measurement: Glucose oxidase

2

Description: Fasting insulin
Timepoint: Fasting insulin measurement at the beginning of the study, three and six months after the start of the intervention
Method of measurement: chemiluminescence

3

Description: Insulin resistance index
Timepoint: Insulin resistance index calculating at the beginning of the study, three and six months after the start of the intervention
Method of measurement: Using the formula

4

Description: Serum triglyceride
Timepoint: Serum triglyceride measurement at the beginning of the study, three and six months after the start of the intervention
Method of measurement: Photometric

5

Description: Total serum cholesterol
Timepoint: Total serum cholesterol measurement at the beginning of the study, three and six months after the start of the intervention
Method of measurement: Photometric

6

Description: Serum low-density lipoprotein (LDL)
Timepoint: Serum low-density lipoprotein (LDL) measurement at the beginning of the study, three and six months after the start of the intervention
Method of measurement: Photometric

7

Description: Serum High-density Lipoprotein (HDL)
Timepoint: Serum High-density Lipoprotein (HDL) measurement at the beginning of the study, three and six months after the start of the intervention
Method of measurement: Photometric

8

Description: Physical activity score
Timepoint: Physical activity score measurement at the beginning of the study, three and six months after the start of the intervention
Method of measurement: Physical activity record questionnaire

9

Description: Average percentage of feasibility
Timepoint: Average percentage of feasibility measurement three and six months after the start of the intervention
Method of measurement: Feasibility questionnaire

10

Description: Quality-adjusted life year (QALY) score
Timepoint: Quality-adjusted life year (QALY) score measurement at the beginning of the study, three and six months after the start of the intervention
Method of measurement: The EuroQol 5-Dimension 5-level (EQ-5D-5L) questionnaire

11

Description: Cost-effectiveness
Timepoint: Cost-effectiveness measurement six months after the start of the intervention
Method of measurement: Cost-effectiveness = (COST int - COST non-int) / (Remission% int - Remission% non-int)

12

Description: Cost-utility
Timepoint: Cost-utility measurement six months after the start of the intervention
Method of measurement: Cost-utility = (COST int - COST non-int) / (QALY int - QALY non-int)

13

Description: Cost per patient
Timepoint: Cost per patient measurement at the beginning of the study, three and six months after the start of the intervention
Method of measurement: Direct and indirect cost questionnaire

14

Description: Number of medicine
Timepoint: Number of medicine measurement at the beginning of the study, three and six months after the start of the intervention
Method of measurement: Questionnaire

Intervention groups

1

Description: First intervention group: calories-carbohydrates restricted diet group (CCR) Integrated lifestyle intervention phase (ILI) 0 to 12 weeks Behavior modification The conceptual framework of the behavioral intervention of this study is based on the IMB model developed by Fisher et al. (60), which is based on the components of knowledge, motivation, and behavioral skills. While the knowledge component expresses specific knowledge about correct health behavior, the motivation component includes individual and social motivation. Personal motivation reflects a person's attitude or beliefs, social motivation is based on perceived social support. Behavioral skills include self-efficacy and having skills to improve health status by reducing negative consequences. In the present study, a diabetes self-management program based on the IMB model is designed to improve knowledge through face-to-face training and also to improve motivation and self-management behavioral skills through virtual space and telephone counseling. After initial assessments, intervention groups will receive a 12-week diabetes self-management program. Strategies to improve diabetes knowledge: face-to-face diabetes self-management training is provided to participants in this study. The content of the training will be determined by reviewing clinical guidelines and articles in this field. This educational content will include general information about diabetes (definition, symptoms, and complications of diabetes), the possibility of diabetes remission, and its importance. Also, information about self-monitoring of blood glucose, diet content, monitoring carbohydrate intake, increasing protein intake, managing hypoglycemia, and hyperglycemia, information about type and duration of physical activity, weight, and blood pressure control will be provided. In face-to-face training with small groups of four to five patients for 60 to 90 minutes in one session, a PowerPoint presentation, discussion, question and answer methods will be used. Strategies for Enhancing Motivation and Behavioral Skills for Diabetes Self-Management: Researchers will use phone calls, short reminder messages for blood glucose reporting, and discussion to increase motivation and behavioral skills. Weekly telephone calls, lasting 10 minutes, are designed to address self-management behavior problems and barriers and potentially improve motivation and behavioral skills, and patients are encouraged to ask questions. Before conducting the telephone consultation, the researcher checks the measured blood glucose levels that patients reported via text message, then calls the participant at the agreed time and uses communication skills such as asking open-ended questions, active listening, empathy, and reflection to resolve possible problems. Diet In the ILI phase, for the Continuous Calorie-carbohydrate Restriction (CCR) group, the goal is to reduce total caloric intake to 1000-1200 kcal per day as a low-energy diet (LED). Also, this diet is food-based by restricting carbohydrates to 40%, 30% fat and 30% protein. Very low-energy diets (VLED) and low-energy diets (LED) are most effective in achieving significant weight loss (61). In a systematic review and meta-analysis of six randomized controlled trials (62), when VLEDs were compared with LED, VLEDs resulted in greater short-term weight loss than LED, but similar long-term weight loss. A recent study reported that the LED approach was as effective as VLED. LEDs are probably better tolerated by patients than VLEDs due to fewer side effects (63, 64), thus improving dietary compliance and reducing patient dropout. Carbohydrate restriction is based on a U-shaped effect that has been showing for total cholesterol and LDL cholesterol with the greatest reduction in carbohydrate level of 40% in diet (39). The macronutrient composition of this intervention group is 40% carbohydrates, 30% fat (≤7% saturated fat, less than 200 mg cholesterol per day), with 30 to 40 grams of fiber per day and 30% protein. Physical activity In the ILI phase, based on the guidelines of the American College of Sports Medicine and the American Diabetes Association regarding physical activity, we will implement interventions related to increasing physical activity (69) in such a way that at least 150 minutes per week of moderate-intensity exercise with a gradual increase in the speed is recommended that they can start with 75 minutes of exercise per week, in the form of a combination of aerobic and strength exercises. Participants are encouraged to increase their usual physical activity through methods such as replacing cars with walking, taking stairs instead of the elevator, and reducing television time. Regular life activities are as effective as planned (aerobic) activity in weight management. Participants are asked to record their daily steps using a pedometer app and try to increase their daily steps by 250 steps per week until they reach a goal of 10,000 steps per day (70, 71). Medicine protocol The dose of antidiabetic drugs is adjusted and recorded by the endocrinologist according to the blood glucose level. Once participants met the criteria for reducing antidiabetic medications, the physician followed the principles of medication adjustment (72):Due to the carbohydrate restriction applied in the diet of both intervention groups, initially, SGLT2 inhibitor drugs will be discontinued. During the intervention period, if the total average of 2-week blood glucose records is ≤140 mg/dL, first a thiazolidinedione is reduced or discontinued, then an alpha-glucosidase inhibitor, and finally metformin is discontinued. If the average of all 2-week blood glucose recordings is greater than 140 mg/dL, medications are restarted. Frequency and format of visits The intervention in the present study will be a combination of group and individual therapy. Group therapy, in addition to reducing costs, provides social support and a potentially healthy atmosphere of competition (73). Individual therapy, compared to group therapy, potentially creates a stronger bond with the participant and allows them to share more details about their family members, work, or specific situations (71). To use the advantages of both approaches, this combination of group and individual therapy is chosen. Participants are assigned to groups of 4 to 5 members with whom they attend classes throughout the study. During the first 3 months, participants attend one group session (60-90 minutes) during the first week of the ILI phase. They also have five individual face-to-face sessions (30-45 minutes) every two weeks with their nutritionists, who remain the same throughout the study. In addition, participants will have twice-weekly blood sugar reports as well as weekly weight reports available via call or social media. These individual sessions allow participants to explore specific questions or problems. Structured maintenance and monitoring (MSM) phase 12 to 24 weeks Maintain modified behaviors The focus of planned programs in these three months is on the behaviors related to maintaining weight loss in participants to prevent the return of related complications, which is achieved by learning how to manage weight gain and also motivating the participants. For this purpose, in monthly group meetings during these three months, we will have a motivational campaign focusing on increasing physical activity, improving body image, self-esteem, and choosing healthy food. Weight maintenance diet and physical activity Participants are advised to follow a food-based diet and are provided with individually adjusted energy and dietary intake to support weight stabilization and prevent weight regain. Group meetings during this period emphasize the consumption of more fruits especially vegetables and other foods by a low-energy diet. Participants are encouraged to continue to monitor their calories and diet composition. The goal of physical activity for these three months is 150 minutes per week of moderate-intensity activity. All are instructed to strive for 10,000 steps or more per day, as measured by a pedometer. Frequency and format of visits During weeks 12 to 24, participants will attend one group session per month, and the last appointment will be held at week 24 for the final assessment. We also ask the participants to report their blood sugar and any complications twice a week and their weight weekly to maintain their safety. The reduced visit schedule represents a goal to support patients' efforts to maintain weight loss and physical activity. Studies have shown that monthly group sessions facilitate the maintenance of lost weight while keeping participants in the study treatment period (71, 75). Therefore, we have chosen this program style of group meetings, while refraining from continuing with monthly individual meetings. In other weeks, participants are taught to record their weight at home and monitor their eating and physical activity records, in other words, to have a major role in managing their health.
Category: Treatment - Other

2

Description: Second intervention group:Intermittent fasting diet with calories-carbohydrates restriction group (IFCCR) Integrated lifestyle intervention phase (ILI) 0 to 12 weeks Behavior modification The conceptual framework of the behavioral intervention of this study is based on the IMB model developed by Fisher et al. (60), which is based on the components of knowledge, motivation, and behavioral skills. While the knowledge component expresses specific knowledge about correct health behavior, the motivation component includes individual and social motivation. Personal motivation reflects a person's attitude or beliefs, social motivation is based on perceived social support. Behavioral skills include self-efficacy and having skills to improve health status by reducing negative consequences. In the present study, a diabetes self-management program based on the IMB model is designed to improve knowledge through face-to-face training and also to improve motivation and self-management behavioral skills through virtual space and telephone counseling. After initial assessments, intervention groups will receive a 12-week diabetes self-management program. Strategies to improve diabetes knowledge: face-to-face diabetes self-management training is provided to participants in this study. The content of the training will be determined by reviewing clinical guidelines and articles in this field. This educational content will include general information about diabetes (definition, symptoms, and complications of diabetes), the possibility of diabetes remission, and its importance. Also, information about self-monitoring of blood glucose, diet content, monitoring carbohydrate intake, increasing protein intake, managing hypoglycemia, and hyperglycemia, information about type and duration of physical activity, weight, and blood pressure control will be provided. In face-to-face training with small groups of four to five patients for 60 to 90 minutes in one session, a PowerPoint presentation, discussion, question and answer methods will be used. Strategies for Enhancing Motivation and Behavioral Skills for Diabetes Self-Management: Researchers will use phone calls, short reminder messages for blood glucose reporting, and discussion to increase motivation and behavioral skills. Weekly telephone calls, lasting 10 minutes, are designed to address self-management behavior problems and barriers and potentially improve motivation and behavioral skills, and patients are encouraged to ask questions. Before conducting the telephone consultation, the researcher checks the measured blood glucose levels that patients reported via text message, then calls the participant at the agreed time and uses communication skills such as asking open-ended questions, active listening, empathy, and reflection to resolve possible problems. Diet In the ILI phase, for the Intermittent Fasting with Calorie-Carbohydrate Restriction group (IFCCR), the goal is still to reduce total caloric intake to 1000-1200 kcal per day as a low-energy diet (LED) and a food-based diet by restricting carbohydrates to 40%, 30% fat, and 30% protein. In addition to the above conditions, the time limit for receiving energy under the name of intermittent fasting is also applied. Intermittent fasting without adequate replacement of protein is one of the known causes of muscle wasting and should be avoided, and increasing protein consumption also helps to increase the feeling of satiety (65). In this study, we will use time-restricted feeding (TRF, restricting food intake to specific periods of the day). It has been shown that the benefits of TRF beyond energy restriction may include altering the endogenous circadian cycle (66). The TRF protocol of our study is that from 10 am to 6 pm for energy consumption an eating period (8 hours) and the remaining hours (16 hours) will be fasting time. It is better to gradually introduce intermittent fasting in the form of time-limited nutrition (67). During the feeding window, patients are encouraged to eat a restricted calorie and carbohydrate diet, especially refined carbohydrates, which lower blood glucose and insulin secretion, and participants are also advised to increase protein intake to help increase satiety (66) and a limited diet of saturated fat and also focusing on poly and monounsaturated fatty acids will be prescribed. Other concerns surrounding this diet with these conditions, although unlikely, include vitamin and mineral deficiencies. Patients should be educated about the importance of eating nutrient-dense meals and adequate protein intake during feeding periods. Patients should also be counseled on the need for adequate hydration during fasting periods. For constipation, which is a common side effect, fiber supplements (psyllium/inulin) are recommended if needed. They are advised to drink 2 liters of water per day (68). Physical activity In the ILI phase, based on the guidelines of the American College of Sports Medicine and the American Diabetes Association regarding physical activity, we will implement interventions related to increasing physical activity (69) in such a way that at least 150 minutes per week of moderate-intensity exercise with a gradual increase in the speed is recommended that they can start with 75 minutes of exercise per week, in the form of a combination of aerobic and strength exercises. Participants are encouraged to increase their usual physical activity through methods such as replacing cars with walking, taking stairs instead of the elevator, and reducing television time. Regular life activities are as effective as planned (aerobic) activity in weight management. Participants are asked to record their daily steps using a pedometer app and try to increase their daily steps by 250 steps per week until they reach a goal of 10,000 steps per day (70, 71). Medicine protocol The dose of antidiabetic drugs is adjusted and recorded by the endocrinologist according to the blood glucose level. Once participants met the criteria for reducing antidiabetic medications, the physician followed the principles of medication adjustment (72):Due to the carbohydrate restriction applied in the diet of both intervention groups, initially, SGLT2 inhibitor drugs will be discontinued. During the intervention period, if the total average of 2-week blood glucose records is ≤140 mg/dL, first a thiazolidinedione is reduced or discontinued, then an alpha-glucosidase inhibitor, and finally metformin is discontinued. If the average of all 2-week blood glucose recordings is greater than 140 mg/dL, medications are restarted. Frequency and format of visits The intervention in the present study will be a combination of group and individual therapy. Group therapy, in addition to reducing costs, provides social support and a potentially healthy atmosphere of competition (73). Individual therapy, compared to group therapy, potentially creates a stronger bond with the participant and allows them to share more details about their family members, work, or specific situations (71). To use the advantages of both approaches, this combination of group and individual therapy is chosen. Participants are assigned to groups of 4 to 5 members with whom they attend classes throughout the study. During the first 3 months, participants attend one group session (60-90 minutes) during the first week of the ILI phase. They also have five individual face-to-face sessions (30-45 minutes) every two weeks with their nutritionists, who remain the same throughout the study. In addition, participants will have twice-weekly blood sugar reports as well as weekly weight reports available via call or social media. These individual sessions allow participants to explore specific questions or problems. Structured maintenance and monitoring (MSM) phase 12 to 24 weeks Maintain modified behaviors The focus of planned programs in these three months is on the behaviors related to maintaining weight loss in participants to prevent the return of related complications, which is achieved by learning how to manage weight gain and also motivating the participants. For this purpose, in monthly group meetings during these three months, we will have a motivational campaign focusing on increasing physical activity, improving body image, self-esteem, and choosing healthy food. Weight maintenance diet and physical activity Participants are advised to follow a food-based diet and are provided with individually adjusted energy and dietary intake to support weight stabilization and prevent weight regain. Group meetings during this period emphasize the consumption of more fruits especially vegetables and other foods by a low-energy diet. Participants are encouraged to continue to monitor their calories and diet composition. The goal of physical activity for these three months is 150 minutes per week of moderate-intensity activity. All are instructed to strive for 10,000 steps or more per day, as measured by a pedometer. Frequency and format of visits During weeks 12 to 24, participants will attend one group session per month, and the last appointment will be held at week 24 for the final assessment. We also ask the participants to report their blood sugar and any complications twice a week and their weight weekly to maintain their safety. The reduced visit schedule represents a goal to support patients' efforts to maintain weight loss and physical activity. Studies have shown that monthly group sessions facilitate the maintenance of lost weight while keeping participants in the study treatment period (71, 75). Therefore, we have chosen this program style of group meetings, while refraining from continuing with monthly individual meetings. In other weeks, participants are taught to record their weight at home and monitor their eating and physical activity records, in other words, to have a major role in managing their health.
Category: Treatment - Other

3

Description: Control group: Control group and standard care Integrated lifestyle intervention phase (ILI) 0 to 12 weeks In this group, standard and routine care is recommended to participants according to clinical guidelines related to diabetic patients (74). The participants assigned to this group are followed up in the 3-month ILI phase, and clinical evaluations are performed and recorded for them at the beginning and end of the phase. Standard recommendations for diet, physical activity, and diabetes education will be provided in the form of individual counseling to the participants of this group according to ADA recommendations. Structured maintenance and monitoring (MSM) phase 12 to 24 weeks In this group, as in the first phase, standard and routine care is performed according to the clinical guidelines related to patients with diabetes (74). The participants assigned to this group are followed up in the 3-month MSM phase, and clinical evaluations are performed and recorded for them at the beginning and end of the phase.
Category: Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Imam Khomeini Hospital, Department of Endocrine and Metabolism

Full name of responsible person

Dr Sakineh Shab-Bidar

Street address

Imam Khomeini Hospital Complex, End of Keshavarz Blvd., Tehran, Iran.

City

Tehran

Province

Tehran

Postal code

1419733141

Phone

+98 21 6658 1587

Email

sakinehshab@gmail.com

2

Recruitment center: Name of recruitment center

Sports and Exercise Medicine Research Center, Tehran university of medical science

Full name of responsible person

Dr Sakineh Shab-Bidar

Street address

No. 7, Jalal-e-Al-e-Ahmad Hwy, Tehran Province, Iran

City

Tehran

Province

Tehran

Postal code

۱۴۱۱۷۳۴۱۴۱

Phone

+98 21 8863 0227

Email

sakinehshab@gmail.com

1

Sponsor: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Dr Sakineh Shab-Bidar

Street address

School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No 44, Hojjat-dost Alley, Naderi St.

City

Tehran

Province

Tehran

Postal code

1417613151

Phone

+98 21 8895 5742

Email

sakinehshab@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Tehran University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Negin Badrooj

Position

Student

Latest degree

Master

Other areas of specialty/work

Nutrition

Street address

School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No: 44 Hojjat-dost Alley, Naderi St.

City

Tehran

Province

Tehran

Postal code

1417613151

Phone

+98 21 8895 5814

Email

badroojnegin@yahoo.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Dr Sakineh Shab-Bidar

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No: 44 Hojjat-dost Alley, Naderi St.

City

Tehran

Province

Tehran

Postal code

1417613151

Phone

+98 21 8895 5742

Email

sakinehshab@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Negin Badrooj

Position

Student

Latest degree

Master

Other areas of specialty/work

Nutrition

Street address

School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No: 44 Hojjat-dost Alley, Naderi St.

City

Tehran

Province

Tehran

Postal code

1417613151

Phone

+98 21 8895 5814

Fax

Email

badroojn@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: Regarding the sharing of individual data of study participants, the data will be made available to the applicant upon reasonable request.
When the data will become available and for how long: The access period starts 6 months after the results are published
To whom data/document is available: Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used: Any type of data use must be coordinated and subject to the consent of the scientific person responsible for the study.
From where data/document is obtainable: Scientific responsible for the study: Dr. Shab-Bidar via e-mail sakinehshab@gmail.com
What processes are involved for a request to access data/document: The applicant must correspond with scientific responsible for the study through email, and if she approves, the documents will be sent within two weeks.
Comments