| CTRI Number |
CTRI/2025/01/079158 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Other (Specify) [Physical activity(Aerobic exercise))] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of Weekly Iron Folic Acid Supplementations along with aerobic exercise on hemoglobin status of adolescents |
|
Scientific Title of Study
|
Effect of Weekly Iron Folic Acid
Supplementations with and without aerobic
exercise for 12 weeks on hemoglobin status of
School going adolescents in rural area of
Dehradun: Cluster randomized 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 |
Dr Kanchan Gupta |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Level 5,Department of Community and family medicine, AIIMS Rishikesh, Virbhadra road, Rishikesh.
AIIMS Rishikesh, virbhadra road, Rishikesh Dehradun. 249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9026731161 |
| Fax |
|
| Email |
kanchibillaiya16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Sinha |
| Designation |
Additional professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Community and Family medicine, level 5 , AIIMS Rishikesh
AIIMS Rishikesh, veerbhadra road, Rishikesh Dehradun 249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9818306781 |
| Fax |
|
| Email |
smita.mailid@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanchan Gupta |
| Designation |
Junior resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Level 5, Department of community and family medicine, AIIMS Rishikesh, Virbhadra road, Rishikesh.
AIIMS Rishikesh, virbhadra road, Rishikesh Dehradun. 249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9026731161 |
| Fax |
|
| Email |
kanchibillaiya16@gmail.com |
|
|
Source of Monetary or Material Support
|
| The study has not received any funding from external sources,have applied for ICMR grant, results are awaited, this study is being conducted in two public schools out of a total of six
schools located in the rural field practice area of the primary health Centre under the
Department of Community and Family Medicine of AIIMS Rishikesh, virbhadra road, uttarakhand 249203 |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh, virbhadra road , Rishikesh Dehradun 249203 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kanchan Gupta |
Rural field practice area of the Department of CFM of AIIMS Rishikesh |
Two public schools of Raiwala, rural area of dehradun, 249205
Dehradun
UTTARANCHAL |
9026731161
kanchibillaiya16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
School students under the WIFS Programme aged 12 to 14 years, having baseline hemoglobin levels in the range of mild and moderate anemia(8gm/dl to 11gm/dl) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic exercise(spot jogging) |
School students already under WIFS Programme will be given intervention of Aerobic exercise (spot jogging) for time period of
6 weeks (5 days/week), duration of 30 mins, three sub sessions of 9mins each with
break of one min between each session, min 18 sessions are mandatory before endline
Hb assessment. |
| Comparator Agent |
Weekly iron folic acid supplementations |
School students under WIFS Programme |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Baseline hemoglobin levels in the range of mild and moderate anemia (8g/dL to 11g/dL)
2.School attendance rate of more than 75% |
|
| ExclusionCriteria |
| Details |
1.Acute illness currently or of more than 2 weeks duration in last three months
2.Any other disease which can hinder participation in aerobic exercise.
3.On any medication or in any other exercise programme.
4.Known case of cardiopulmonary disease or kidney disorder or peptic ulcers.
5.Student not compliant with blood lancet pricking
6.Reported participation in another biomedical trial 3 months before the start of the study or during the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the mean hemoglobin levels of school going adolescents |
Outcomes of the changes in the mean hemoglobin levels at baseline, after 4 weeks and after 12 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Physical activity level will be done by the 2021 version of GSHS Core
Questionnaire Physical Activity Module. |
Baseline assessment and then after 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
06/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
06/06/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Despite continuous approach regarding the improvement of Anemia status of Indian population, there is no significant observed increase in hemoglobin concentrations, which suggests that new interventions are needed along with supplementation, as most of the literature shows that level of physical activity is associated with Hb level but here is a lack in any defined physical activity, which can affect the Hb levels. Currently no study was found in INDIA regarding effectiveness of Physical activity along with WIFS on Hemoglobin concentration in young adolescents. So, objective of the current study is to determine physical activity improving hemoglobin concentration along with WIFS in school going adolescents and to understand the cause-and-effect relationship of Physical activity on Hb levels. AIM- To assess effects of aerobic exercise (spot jogging) and Weekly Iron Folic Acid Supplementations on the mean hemoglobin status compared to Weekly Iron Folic Acid supplementation alone among school going adolescents of rural Dehradun. METHODOLOGY- The study design will be cluster randomized controlled trial, here cluster unit being the school, out of six public schools located in the rural field practice area of the Department of Community and Family Medicine of a tertiary medical college in Northern India, two schools will be randomly assigned to either intervention group or control group. From each school 25 students of class 6-8 will be recruited for study after assessing the eligibility criteria. If sample size will be achieved by randomly selecting any one class from 6-8 then recruitment process will stop, however if sample size will not be achieved then two class will be merged and all the students will be assessed for eligibility. The study will be carried out for a duration of 12 months. However, intervention will be given for 12 weeks duration for five days/week and each session will be of 30 minutes duration. It is assumed that over 12 weeks duration only 60 school days will be there, rest being school holidays. The intervention will be given only on school days and study participants will be school going adolescents in the age group 12-14 years. After taking written informed consent from the students as well as their parents, student will be recruited for the study. Before starting the intervention, one week will be taken for Induction period in the intervention school, for training students to perform moderate aerobic exercise (spot jogging) via interactive video sessions. Everyday adherence to the physical activity will be assessed, development of any giddiness during physical activity will result in removal of the participant completely from the intervention as well as the research trial. Baseline hemoglobin estimation will be done by Hemo CUE instrument. Baseline assessment of Physical activity of the participants of both the Intervention and Control arm will also be done by the 2021 version of GSHS Core Questionnaire Physical Activity Module. Again, at the end of study it will be done. Participant’s socio-demographic details and dietary intake will also be assessed at baseline and endline through structured interview schedule. In the control arm weekly visits will be given to check the availability and administration of WIFS to students under WIFS supplementation programme and if possible, the drug will be administered orally under supervision. After 4 weeks, the Hemoglobin estimation via the Hemo CUE instrument will be taken of both the arms and for the final assessment after 12 weeks of intervention. In the control arm weekly visits will be given to check the availability and administration of WIFS to students under WIFS supplementation programme and if possible, the drug will be administered orally under supervision. After 4 weeks, the Hemoglobin estimation via the Hemo CUE instrument will be taken of both the arms and for the final assessment after 12 weeks of intervention. OUTCOME-The primary outcome is the changes in the mean Hb levels of both the intervention and control arm at baseline , after 4 weeks and at the end if 12 weeks of intervention and secondary outcome is to assess the physical activity level in both the arms through 2021 version of GSHS Core Questionnaire Physical Activity Module at baseline and at the end of 12 weeks of intervention. ANALYSIS- Data will be entered in Epi Info 3.5.4 (CDC 2012) and will be cleaned and checked for consistency using Microsoft excel 2010. Data analysis will do using SPSS 23.0 statistical package. Descriptive statistics will be presented as proportion with 95% confidence interval and mean with standard deviation. Comparison of intervention 29 and control arms will be done at baseline to check for any statistically significant difference. Median attendance will be compared between the two groups at the baseline and at the end of the follow up. For bi-variate analysis, chi square test and Fischer’s exact test will be used for categorical variable and student’s T test and ANOVA will be used for comparison of means. Multivariate analysis will be done to adjust for confounders, both at individual level and cluster level. DISCUSSION-This trial is expected to provide valuable insights into the efficacy of combining Aerobic exercises with WIFS to improve the hemoglobin status of school going adolescents having mild to moderate anemia, compared to WIFS(Weekly iron folic acid supplementations) alone. |