MedPath

Women centric weight management module

Phase 2
Conditions
Health Condition 1: E660- Obesity due to excess calories
Registration Number
CTRI/2022/05/042599
Lead Sponsor
Department of science and technology DST
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
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 <=39.9kg/m2.

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 <=39.9kg/m2.

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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Body weight loss post treatment.Timepoint: 6 months
Secondary Outcome Measures
NameTimeMethod
2.Change in Biochemical parameters fasting blood glucose, lipid profile, fasting insulin, <br/ ><br>Body Composition Analysis after six months of enrolment.Timepoint: 6 month.
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