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NCT01084941 · ClinicalTrials.gov registry record · Phase 4
Lifestyle Intervention to Limit Excessive Weight Gain During Pregnancy in Minority Women
A Phase 4 study, sponsored by Guillermo Umpierrez.
- Completed
- Registry status
- Phase 4
- Development phase
- 57
- Enrollment target
NCT01084941 is a Phase 4 study that has completed, run by Guillermo Umpierrez. The registered enrollment target is 57 participants.
The verdict
NCT01084941, a Phase 4 study, has completed, sponsored by Guillermo Umpierrez.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 57 participants
- Enrollment target
Study Summary
The prevalence of overweight and obesity is increasing among pregnant women in the United States. More than one-third of women of reproductive age in the US are overweight or obese, and two thirds of women gain more weight in pregnancy than is recommended by the Institute of Medicine guidelines. Maternal obesity during pregnancy increases the risk of complications to both mother and child. Minority women (Blacks and Hispanics) have higher rates of overweight and obesity when they become pregnant, experience higher rates of excessive weight gain during pregnancy, and experience higher rates of maternal and neonatal complications after adjusting for sociodemographic characteristics and comorbidities than Caucasian women. Epidemiologic studies indicate that lifestyle modification programs based on diet and exercise are promising approaches in controlling weight gain as well as in preventing type 2 diabetes in populations at risk. We hypothesize that overweight/obese minority women (Blacks and Hispanics) assigned to a culturally-grounded lifestyle intervention program based on diet and moderate exercise will result in higher compliance with Institute of Medicine guidelines for weight gain than women receiving standard care. Such lifestyle modifications should reduce risk of maternal and neonatal complications. We propose 1) to determine whether a lifestyle intervention program, based on diet and moderate physical activity implemented shortly after first recognition of pregnancy, will result in higher compliance with Institute of Medicine guidelines for weight gain compared to women receiving standard care; 2) to determine the occurrence of carbohydrate intolerance and GDM at 24-28 weeks gestation (after the first 10-12 weeks of intervention) and at 6 weeks postpartum between women in the lifestyle intervention group and women receiving standard care; and 3) to explore the impact of the lifestyle intervention on the development of maternal and fetal complications during
Interventions
- BEHAVIORAL Standard of Care
- BEHAVIORAL Lifestyle Intervention group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01084941
The ClinicalTrials.gov registry entry for NCT01084941 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Guillermo Umpierrez, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT01084941 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01084941 about?
NCT01084941 is a clinical study titled "Lifestyle Intervention to Limit Excessive Weight Gain During Pregnancy in Minority Women". The prevalence of overweight and obesity is increasing among pregnant women in the United States. More than one-third of women of reproductive age in the US are overweight or obese, and two thirds of women gain more weight in pregnancy than is recommended by the Institute of Medicine guidelines. Mat...
What is the current status of trial NCT01084941?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 57 participants. The study started on 2010-04. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01084941?
The interventions under investigation include: Standard of Care (BEHAVIORAL), Lifestyle Intervention group (BEHAVIORAL).
Who is sponsoring clinical trial NCT01084941?
This trial is sponsored by Guillermo Umpierrez, which has 2 total clinical trials registered on ClinicalTrials.gov.
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