Clinical trial NCT00942097: Homeopathic Medication and Nutritional Oriented Diet to Treat Overweight Pregnant Women With Mental Disorder
Official title: Homeopathic Treatment in Pregnant Women With Overweight and Mental Disorder: a Double Blinded Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Overweight
Pregnancy
Mental Disorder
Keywords: Homeopathy
overweight
obesity
mental disorder
pregnancy
Overweight pregnant women with suspicious mental disorder
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Amparo Maternal Maternidade Social
First posted: 2009-07-20
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of homeopathic treatment in pregnant women with overweight and class I obesity with suspicion of a mental disorder.

Detailed description: The weight gain during pregnancy has been reported as an important factor of being overweight after delivery and comorbidities. There are a lot of restrictions to treat pregnant women due to fetus development. Homeopathy presents itself as an integrative medicine that could treat with less collateral effects improving general health. The investigators are going to test the effects of homeopathy.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with less than 28 weeks,
* BMI from 26 to 35 Kg/ m2,
* SRQ-20 positive.

Exclusion Criteria:

* Diabetes
* Cardiopathies
* Hypertension
* Nephropathies
* Psychiatric treatment
* Drug users
* Pulmonary Chronic Disease
* Suicidal ideas
* No eating (appetites)
* Problems of BMI measurements (disabled people)
* Concomitant homeopathic treatment
* People who are looking for just 1 medical appointment

Primary outcomes:
measure: Weight
timeFrame: 9 months
Secondary outcomes:
measure: Comorbidities
timeFrame: 9 months
measure: Newborn weight
timeFrame: 9 months
measure: Pregnancy period
timeFrame: 9 months
measure: Collateral effects
timeFrame: 9 months
measure: Self perception health
timeFrame: 9 months
measure: Apgar score
timeFrame: 9 month
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Amparo Maternal Maternidade Social
Study officials:
affiliation: Medicine School - University of São Paulo
name: Edgard C Vilhena, MD
role: PRINCIPAL_INVESTIGATOR
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