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NCT03146156 · ClinicalTrials.gov registry record · NA
Lifestyle Intervention in Preparation for Pregnancy (LIPP)
A NA study, sponsored by Tufts Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 99
- Enrollment target
NCT03146156 is a NA study that has completed, run by Tufts Medical Center. The registered enrollment target is 99 participants.
The verdict
NCT03146156, a NA study, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 99 participants
- Enrollment target
Study Summary
Studies evaluating lifestyle intervention in obese women during pregnancy have reported limited success in decreasing excessive gestational weight gain, and have failed to achieve the key outcome of breaking the obesity cycle and reducing neonatal adiposity or birth weight. Although some investigators advocate weight loss during pregnancy in obese women, these recommendations were based on extrapolation of retrospective epidemiological data. Of concern, we reported increased small for gestational age babies and decreased lean body mass in neonates of obese women with weight loss or inadequate gestational weight gain. Based on our research, optimal outcomes from lifestyle interventions are likely to be temporal and therefore must be initiated prior to conception to first improve maternal metabolic function, and subsequently, placental/fetal growth. Several large retrospective cohort studies support our hypothesis. For example, women who lost weight between pregnancies had fewer large for gestational age babies in contrast to women who increased interpregnancy weight. In addition, prospective randomized controlled trials have shown that postpartum weight loss is achievable without adverse maternal or neonatal outcomes, these studies include women who breastfed. Based on these observations, we propose a randomized control trial to determine the effect of lifestyle intervention initiated prior to a planned pregnancy on improving neonatal metabolism and adiposity. Our overarching hypothesis is that the maternal pre-pregnancy metabolic condition determines the obesogenic in-utero environment, which affects programming of placental mitochondrial function and metabolic pathways, promoting lipid accumulation and neonatal adiposity. Our rationale is based on the need to establish the most effective time to introduce an intervention that will break the obesity cycle in mothers and their children. Understanding how pregravid metabolic conditioning improves maternal physiology,
Interventions
- BEHAVIORAL Lifestyle Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2017-03-21 |
| Est. Completion | 2025-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03146156
The ClinicalTrials.gov registry entry for NCT03146156 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lifestyle Intervention is the first listed.
NCT03146156 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03146156 about?
NCT03146156 is a clinical study titled "Lifestyle Intervention in Preparation for Pregnancy (LIPP)". Studies evaluating lifestyle intervention in obese women during pregnancy have reported limited success in decreasing excessive gestational weight gain, and have failed to achieve the key outcome of breaking the obesity cycle and reducing neonatal adiposity or birth weight. Although some investigato...
What is the current status of trial NCT03146156?
This trial is currently completed. It is a NA study. The enrollment target is 99 participants. The study started on 2017-03-21. Estimated completion is 2025-08-31.
What interventions are being tested in trial NCT03146156?
The interventions under investigation include: Lifestyle Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03146156?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
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