Women centric weight management module
- 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
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.
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
Name Time Method Body weight loss post treatment.Timepoint: 6 months
- Secondary Outcome Measures
Name Time Method 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.