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NCT01693666 · ClinicalTrials.gov registry record · NA
Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)
A NA study, sponsored by St. Louis University.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01693666: Completed NA study, sponsored by St. Louis University.
NCT01693666 is a NA study that has completed, run by St. Louis University. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01693666, a NA study, has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Gaining too much weight in pregnancy is associated with adverse pregnancy complications and can have a long-term impact on maternal and offspring health, including increased risk for obesity and metabolic disease. Preventing excessive gestational weight gain could reduce adverse pregnancy outcomes and improve long-term health of mothers and offspring. Thirty obese (BMI ≥30) pregnant women will be recruited for this pilot study and randomly assigned to the Lifestyle Intervention ForEver (LIFE) program or routine care (RC). Participants will be enrolled before 18 weeks gestation and will be followed until 12 weeks after delivery. Women in the LIFE program will be given guidance on healthy eating and exercise at their regularly scheduled obstetric visits. To increase adherence to the program, a contingency management (CM) intervention offering incentives will be used to establish and maintain healthy nutrition and physical activity habits, working towards the goal of restricted weight gain (± 10lb) during their pregnancy. Three study testing visits will be scheduled for all participants: at study entry, 34-36 weeks gestation, and 12 weeks after delivering. Primary outcomes include adherence to the LIFE program, weight change in pregnancy and postpartum, and objective measures of maternal and offspring health.
Primary Outcome
Maternal weight (lb) will be measured at program entry and at the time of delivery to determine weight gain during the study period. Pre-pregnancy body weight will be self-reported and used to estimate total gestational weight gain (lb).
Interventions
- BEHAVIORAL Lifestyle intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-07 |
| Phase | NA |
What the finished NCT01693666 record still lists
NCT01693666 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Lifestyle intervention is the first listed.
NCT01693666 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01693666 about?
NCT01693666 is a clinical study titled "Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)". Gaining too much weight in pregnancy is associated with adverse pregnancy complications and can have a long-term impact on maternal and offspring health, including increased risk for obesity and metabolic disease. Preventing excessive gestational weight gain could reduce adverse pregnancy outcomes a...
What is the current status of trial NCT01693666?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2012-09. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01693666?
The interventions under investigation include: Lifestyle intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01693666?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01693666's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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