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NCT01812694 · ClinicalTrials.gov registry record · Phase 3
Lifestyle Interventions for Expectant Mothers (LIFE-Moms Phoenix) - Phoenix
A Phase 3 study of Obesity and Diabetes Type 2, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 123
- Enrollment target
- 1
- Study location
NCT01812694: Completed Phase 3 study of Obesity and Diabetes Type 2, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT01812694 is a Phase 3 study of Obesity and Diabetes Type 2 that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 123 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01812694, a Phase 3 study of Obesity and Diabetes Type 2, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 123 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- LIFE-Moms (Lifestyle Interventions for Expectant Moms) is a national project that is studying pregnant women who are overweight or obese. It is looking at ways they can manage their weight gain in pregnancy and how this may affect them and their babies health at birth and through the first year. Researchers want to recruit pregnant women who are being treated at the Phoenix Indian Medical Center. They will participate in a two-part study. Objectives: \- To study pregnant women who are in the LIFE-Moms project at the Phoenix Indian Medical Center. Eligibility: * Pregnant women at least 18 years of age who are overweight or obese. * Participants must be receiving care at the Phoenix Indian Medical Center. * Participants must be having only one child in their pregnancy (no twins or other multiple births). Design: * This study will have two parts. The first part will have three visits to obtain data about health early in pregnancy. It will also let participants and researchers find out if the participants are eligible and should continue in the second part of the study. In the second part, participants will be monitored throughout their pregnancy and during the first year after the baby s birth to test the effects of a lifestyle intervention to control weight gain during pregnancy. * On the Part 1 study visits, participants will have a physical exam and medical history. They will provide blood, urine, hair, and other samples to be examined for possible genetic conditions. * For the Part 2 study visits, participants will be placed in one of two treatment groups. Each group will receive the same prenatal and postnatal care that they would get if they did not join the study. * The first group will have a lifestyle intervention program. They will spend about 2 hours every week with other members of their group to learn diet and activity behaviors that may help with their health. * The second group will have an enhanced care program. They will be given
Primary Outcome
Weight at 36 weeks minus weight at baseline, kg
Conditions Studied
Interventions
- BEHAVIORAL Intensive lifestyle intervention
- BEHAVIORAL Enhanced standard care
Study Locations (1)
Arizona
- NIDDK, Phoenix - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2013-03-28 |
| Est. Completion | 2017-03-27 |
| Phase | Phase 3 |
What the finished NCT01812694 record still lists
NCT01812694 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (85% lower).
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Intensive lifestyle intervention is the first listed.
NCT01812694 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT01812694 about?
NCT01812694 is a clinical study titled "Lifestyle Interventions for Expectant Mothers (LIFE-Moms Phoenix) - Phoenix". Background: \- LIFE-Moms (Lifestyle Interventions for Expectant Moms) is a national project that is studying pregnant women who are overweight or obese. It is looking at ways they can manage their weight gain in pregnancy and how this may affect them and their babies health at birth and through the...
What is the current status of trial NCT01812694?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 123 participants. The study started on 2013-03-28. Estimated completion is 2017-03-27.
What conditions does trial NCT01812694 study?
This clinical trial studies the following conditions: Obesity, Diabetes Type 2, Diet Therapy.
What interventions are being tested in trial NCT01812694?
The interventions under investigation include: Intensive lifestyle intervention (BEHAVIORAL), Enhanced standard care (BEHAVIORAL).
Who is sponsoring clinical trial NCT01812694?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01812694 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01812694's enrollment target sits among peer trials
123 431st of 1053 higher than 623 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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