Development of Perceived Health risk assessment Tool and a Community based Health Risk reduction Sensitization Program

Not yet recruiting

• Conditions: Pregnancy, childbirth and the puerperium,

• Registration Number: CTRI/2024/07/071404
• Lead Sponsor: Department of Health Research

Brief Summary

This proposal aims to develop a multidimensional assessment tool to measure women’s knowledge on and behaviour towards preconception health risks and risk reduction, and one community-based preconception focused integrated risk-reduction programme module.

**Primaryobjectives**

The primary objectives are to:

·      Develop a multi-dimensional preconception healthrisk perception tool for women (including their knowledge, behaviour, andattitudes towards various health indicators such as, weight, diet, anemia, menstrualhealth, thyroid, type-II diabetes mellitus, sexual health, sleep quality, commonmental illnesses, perceived stress and trauma experience, and self-harmbehaviour).

·      Test the psychometric properties of the newlydeveloped tool.

·      Correlate specific dimensions of the riskperception tool with findings from relevant and corresponding clinical and lab investigationswherever applicable (e.g. BMI, Anemia (Complete Blood Count), Thyroid (TFT-FT3,FT4, and TSH), PCOS (though FSH, LH, Progesterone, Estrogen, Serum Testosteroneare not conclusive still for screening/indication purpose we will take), STD(VDRL, HIV, HbSAg, HCV), Random Blood Sugar, and cortisol).

·      Develop a community-based preconception integratedrisk reduction sensitization programme and test its feasibility.

·      Compare two groups (one who has gone throughcommunity-based health risk reduction sensitized programme and the other onewhich has not) on health risk preconception and reproductive health relatedknowledge, attitude, and behaviour.

**Secondary Objective**

Secondary objectives are to:

·      All willing women participants or at least 50%women participants will be followed up till 1 year (w.e.f. the day of firstassessment).

·      Spouse/family members of the women, if willingwill be provided the same sensitization programme.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-07-25
• Study Start: 2024-08-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 1240

Inclusion Criteria

• Women aged 18-35 years planning for a child in next 1-3 years.
• Since in our previous ICMR project the mean age of 880 community samples was around 25 years, we will prefer to limit it 35 years as upper age for women in community sample.
• Women who already have child/children but planning for another child in next 1-3 years Average IQ (medical record/history or clinical judgment).
• Willing to provide written consent.

Exclusion Criteria

•Women aged above 35 years •Women having diagnosed medical/psychiatric illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Develop a multi-dimensional preconception health risk perception tool for women	4 to 8 weeks

Secondary Outcome Measures

Name	Time	Method
All willing women participants or at least 50% women participants will be followed up till 1 year (w.e.f. the day of first assessment).	4-8 weeks

Trial Locations

Locations (2)

Community center Ballabhgarh; 🇮🇳 Faridabad, HARYANA, India

Community Center Dakshinpuri; 🇮🇳 South, DELHI, India

Community center Ballabhgarh

🇮🇳Faridabad, HARYANA, India

Dr Ravneet Kaur

Principal investigator

9654320005

ravneetk08@gmail.com