| CTRI Number |
CTRI/2020/01/022742 [Registered on: 13/01/2020] Trial Registered Prospectively |
| Last Modified On: |
20/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand factors affecting under nutrition in women of 15-24 years in Ramgarh and Dhari block, Nainital district, Uttarakhand. |
|
Scientific Title of Study
|
Factors influencing under nutrition among women of age 15-24 years in Ramgarh and Dhari block, Nainital district, Uttarakhand. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Himadri Bisht |
| Designation |
Post grad |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09886908096 |
| Fax |
|
| Email |
himadri.bisht61@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arathi P Rao |
| Designation |
programme coordinator, Master of Public Health program |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room no 60, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi 576104, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9008418848 |
| Fax |
|
| Email |
arathi.anil@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Himadri Bisht |
| Designation |
Post grad |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09886908096 |
| Fax |
|
| Email |
himadri.bisht61@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Himadri Bisht
Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal 576104,Karnataka |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Non-funded community based study] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Himadri Bisht |
Prasanna School of Public Health |
Department of Health Policy, Manipal Academy of Higher Education, Manipal 576104, Karnataka
Udupi
KARNATAKA |
09886908096
himadri.bisht61@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nutritional status |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
Women between the age of 15-24 years residing in rural areas of Ramgarh and Dhari block in Nainital district. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women as well as chronically ill women will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the factors for under nutrition in women of age 15-24 years. |
January- may 2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The results of my study can be used as a source of information to make informed decisions regarding betterment of the nutritional status of women. |
January-May 2020 |
|
|
Target Sample Size
|
Total Sample Size="338"
Sample Size from India="338"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="338" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2020 |
| Date of Study Completion (India) |
07/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The health of women in reproductive age is related to their diet and nutrition. One important indicator of undernutrition is BMI which is defined as the ratio of weight in kg to height in m2. According to NFHS4 data the prevalence of low BMI in Nainital district in the age group 15-19 years is 32.6% and for women between 20-29 years is 20%. The prevalence is particularly high in the rural areas, that is 20%. In India, both social as well as biological factors are responsible for women to be a vulnerable group to under nutrition throughout the life cycle. An undernourished mother is more likely to produce a child with low birth weight and thus an undernourished child.Therefore, it is important to identify and address the underlying causes for it. Data on the prevalence of undernutrition for the study population was obtained from NFHS4 report for Uttarakhand and the sample size is calculated, which is 338. Two completely rural blocks, Dhari and Ramgarh of Nainital district were purposively selected and the list of villages along with the population for the selected blocks was obtained from census 2011 data for Uttarakhand. Based on the population of the blocks, probability proportional to size sampling is done. As per the census data of 2011 for Uttarakhand, the female population for Dhari and Ramgarh block is 14,669 and 19,407 respectively. Therefore, for probability proportional to size, the number of respondents from Dhari and Ramgarh block is 145 and 193 respectively. The number of villages is 45 and 95 for Dhari and Ramgarh block respectively as per census 2011. To interview the required number of participants 21 villages from Dhari and 28 villages from Ramgarh block will be randomly selected. The households will be randomly chosen and the eligible participants will be interviewed with the help of a questionnaire and along with it, anthropometric measurements will be recorded including height, weight and Body Mass Index (BMI). Height will be measured using an inch tape. Weight will be measured using a weighing machine and the BMI will be calculated using the formula: BMI= weight (Kg)/ [(height)2 (m2 )] Operational definition of undernourished: The individuals who have a BMI less than 18.5 are considered undernourished/ underweight (WHO). The study is being conducted to identify the factors influencing the undernutrition in women of 15-24 years of age. |