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CTRI Number  CTRI/2024/03/064750 [Registered on: 26/03/2024] Trial Registered Prospectively
Last Modified On: 23/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To observe how health education combined with dietary guidance affects nutritional indicators, quality of life and prevention of side effects associated with Anti-tubercular treatment among patients with pulmonary tuberculosis (PTB) 
Scientific Title of Study   Effect of nutritional counselling program on nutritional indicators, Quality of life and side effects associated with anti-tubercular treatment among patients with pulmonary tuberculosis: A Randomised controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nipin Kalal 
Designation  Assistant Professor 
Affiliation  AIIMS Jodhpur 
Address  College of Nursing, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India

Jodhpur
RAJASTHAN
342005
India 
Phone  8955945598  
Fax    
Email  kalalnipin@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nipin Kalal 
Designation  Assistant Professor 
Affiliation  AIIMS Jodhpur 
Address  College of Nursing, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India

Jodhpur
RAJASTHAN
342005
India 
Phone  8955945598  
Fax    
Email  kalalnipin@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nipin Kalal 
Designation  Assistant Professor 
Affiliation  AIIMS Jodhpur 
Address  College of Nursing, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India

Jodhpur
RAJASTHAN
342005
India 
Phone  8955945598  
Fax    
Email  kalalnipin@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Jodhpur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Jodhpur  
Address  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR, BASNI INDUSTRIAL AREA, PHASE II, JODHPUR,RAJASTHAN 342005, INDIA 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nipin Kalal  AIIMS JODHPUR  Pulmonary Medicine Department, OPD Building (Ground Floor B Block) AIIMS Hospital, JODHPUR
Jodhpur
RAJASTHAN 		 8955945598

kalalnipin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of Medical Sciences, Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A150||Tuberculosis of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nutritional Counselling Program  Part 1 – Health Education: The Experimental group will be provided with health education about tuberculosis and the prevention of side effects associated with anti-tubercular treatment. This will involve assessing the current dietary intake of the patient of last three days, and the dietary preferences and discussing the appropriate diet in terms of composition, frequency of meals and snacks. The patient will be advised on how to use to increase the calorie and nutritional density of locally available foods. Health education will be focused on the list of foods to eat and avoid in tuberculosis, a balanced diet with proper calorie, the requirement of micronutrients and a diet which help to prevent or minimize the side effects of anti-tubercle treatment. The diet compliance sheet will be given to the participants to be filled out at their homestay. Part 2 – Educational Booklet: An education booklet along with a compliance sheet will be provided to the Experimental group patients immediately after health education. This diet plan is based on the list of foods to eat and avoid in tuberculosis, a balanced diet with proper calories, requirement of micronutrients and a diet which helps to prevent or minimize the side effects of anti-tubercle treatment and improve the quality of life. Part 3 – Telephone follow-up: Telephonically confirmation and reinforcement will be done once weekly to ensure the compliance of interventions taught to the patient during the Nurse-led nutritional counselling program (will also be reminded to maintain and regularly fill out the compliance sheet). Part 4- Second month follow: On completion of the Second month, the Experimental group participant will be called for a physical follow-up order to see the compliance to the intervention and reinforce the adherence to the diet chart. At this time, data will be not be collected. Part 5- On completion of the third month, both the experimental group and control group participants will be called for the post-intervention data collection which includes nutritional indicators, QoL, medication adherence rating scale, episodes and frequency of side effect associated with anti-tubercular treatment. Part 6- For another 3 months, telephonically every week the reinforcement will be done to the experimental group participants. Part 7- Final data collection will be done on completion of the 6th month and participants of both groups will be called for data collection it includes nutritional indicators, QoL, medication adherence rating scale, episodes and frequency of side effects associated with anti-tubercular treatment and smear test.  
Comparator Agent  Standard Routine Care  Routine Health Education given by Consultant 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients aged between 18 to 65 years.
2. Patients who will be available during the time of data collection.
3. Patients who will be willing to give consent to participate in the study.
4. Patients who can understand Hindi or English.
5. Microbiological confirmed diagnosis of Patients with pulmonary tuberculosis within one month and who are taking ATT.
 
 
ExclusionCriteria 
Details  1. Patients who have severe anaemia.
2. Patient who are relapsed cases
3. Patients who have severe impairment of major organ function.
4. The patient has cognitive impairment.
5. Patients who are pregnant or lactating.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To observe how health education combined with dietary guidance affects nutritional indicators, quality of life and prevention of side effects associated with Anti-tubercular treatment among patients with pulmonary tuberculosis (PTB)  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Frequency of Sideeffects of Anti-tubercular treatment  at 6 months, 1 year 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Pulmonary tuberculosis (PTB) is one of the most common communicable diseases among top ten causes of death worldwide. Tuberculosis is a contagious, infectious disease caused by the bacteria Mycobacterium tuberculosis.[1] PTB is more frequent in immunocompromised and weak individuals, and symptoms include dyspnoea, cough, and afternoon hypothermia.

Undernutrition is one of the major causes of Malnutrition among the patients who are taking Anti-tubercular drugs. However, the studies highlighted the need for evidence concerning the effect of nutritional supplementation on patients on anti-tubercular drugs. As per WHO, 2013 guideline on nutritional care and support for patients with tuberculosis, has recommended the provision of nutritional food as part of a package to improve TB treatment adherence. This further highlighted the strong recommendation of Nutritional assessment and counselling along with management of undernutrition and severe acute malnutrition. Viewing this, we researchers felt a need to do this study on nutritional counselling.

The aim of this study is to observe how health education combined with dietary guidance affects nutritional indicators, quality of life and prevention of side effects associated with Anti-tubercular treatment among patients with pulmonary tuberculosis (PTB), in order to provide a theoretical foundation for improving PTB patients; compliance and treatment outcomes.

Health education combined with dietary guidance for patients with pulmonary tuberculosis can deepen patients’ understanding of disease and nutritional knowledge, improve treatment compliance, improve their nutritional status, enhance their immune function, accelerate sputum bacterial conversion, enhance treatment effect, and improve their quality of life. So we are expecting to get a similar outcome with the help of the nutritional counselling program. 
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