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Women centric weight management module

Development and evaluation of women centric comprehensive weight management module

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042599
Enrollment
220
Registered
2022-05-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E660- Obesity due to excess calories

Interventions

Intervention1: Women centric weight management module: Women centric weight management program for 6 months with intensive counselling sessions on diet, phyical activity and behavioral modification te

Sponsors

Department of science and technology DST
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Group A: Postpartum women i. Women aged between 25-35 years. ii. Women in the postpartum period from 6 weeks to 6 months post-delivery, after 37 week pregnancy term through a normal or C-section delivery. iii. Women who gave singleton birth. iv. BMI between >= 25 to v. Women who can provide a history of pre-pregnancy weight and gestational weight gain (3, 6 and 9 months) as medical record or recall. vi. Women who can read in Hindi/ English. vii. Women who will be lactating. Group B: Perimenopausal women i. Menopausal women aged between 40-55 years. ii. Women with an intact uterus, >= 1 functioning ovary and >=1 menstrual period in past 12 months. iii. BMI between >= 26 to iv. Women who can read in Hindi/ English. v. Intend to follow up regularly will be included in the study. vi. The ownership or accessibility to mobile phones for technology based intervention.

Exclusion criteria

Exclusion criteria: Group A: Postpartum women i) Women with pregnancy related complications (pre-eclampsia, pre-term, hemorrhage, infection). ii) Patients with secondary causes of obesity (like Hypothyroidism, Cushingâ??s diseases, PCOS). iii) Acute infections, advanced end-organ damage or chronic diseases: renal/ hepatic failure, any malignancy iv) Current intake of medicine known to affect body weight such as drugs acting on the central nervous system, cathartics, thyroid supplements, diuretics and selective serotonin reuptake inhibitors. v) Psychosocial contraindications such as bulimia nervosa, anorexia nervosa, substance abuse, clinically significant depression or under current psychiatric care. Group B: Perimenopausal women i. Women using oral or injectable hormonal contraception, tamoxifen, tibolone and raloxifene in the previous 3 months. ii. Patients with secondary causes of obesity (like Hypothyroidism, Cushingâ??s diseases, PCOS). iii. Acute infections, advanced end-organ damage or chronic diseases: renal/ hepatic failure, any malignancy. iv. Current intake of medicine known to affect body weight such as drugs acting on the central nervous system, cathartics, thyroid supplements, diuretics and selective serotonin reuptake inhibitors. v.Psychosocial contraindications such as bulimia nervosa, anorexia nervosa, substance abuse, clinically significant depression or under current psychiatric care. vi. Planning to move out within the study period

Design outcomes

Primary

MeasureTime frame
Body weight loss post treatment.Timepoint: 6 months

Secondary

MeasureTime frame
2.Change in Biochemical parameters fasting blood glucose, lipid profile, fasting insulin, Body Composition Analysis after six months of enrolment.Timepoint: 6 month.

Countries

India

Contacts

Public ContactDr Piyush Ranjan

All India Institute of Medical Sciences New Delhi

drpiyushaiims@gmail.com9268714198

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026