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NCT03880461 · ClinicalTrials.gov registry record · NA
A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
A NA study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 1,335
- Enrollment target
NCT03880461: Completed NA study, sponsored by Kaiser Permanente.
NCT03880461 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 1,335 participants, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03880461, a NA study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,335 participants
- Enrollment target
Study Summary
The aim of this trial is to investigate the effectiveness of a mobile health (mhealth) intervention to help overweight and obese women achieve appropriate gestational weight gain (GWG) for their pre-pregnancy body mass index (BMI). The goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. The investigators propose an adaptive intervention that begins with an effective, yet low resource-intensive treatment and then provides incremental support and resources only to patients who need them. The intervention includes: 1) an mHealth tool allowing data to be automatically transmitted to a mobile website; 2) personalized text messages; and 3) personalized 1:1 telephone coaching sessions. The latter more intensive components are reserved for patients whose GWG is not within the IOM guidelines. The lifestyle intervention will be delivered through 1 telephone counseling session with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and weekly e-mails of core lifestyle intervention sessions. Personalized text messages and 1:1 telephone coaching sessions will be given to those who are not meeting the GWG guidelines. The lifestyle intervention will be compared to usual medical care. Maternal outcomes will be assessed shortly before delivery and at 6 weeks postpartum. Infant birthweight and weight at one year will also be assessed.
Primary Outcome
Calculated as last measured pregnancy weight at the time of delivery minus measured weight at 10 gestational weeks
Interventions
- BEHAVIORAL Lifestyle Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,335 participants |
| Start Date | 2021-01-21 |
| Est. Completion | 2025-03-31 |
| Phase | NA |
What the finished NCT03880461 record still lists
NCT03880461 is an interventional study that assigns participants to a tested intervention. Its 1,335 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Lifestyle Intervention is the first listed.
NCT03880461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03880461 about?
NCT03880461 is a clinical study titled "A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women". The aim of this trial is to investigate the effectiveness of a mobile health (mhealth) intervention to help overweight and obese women achieve appropriate gestational weight gain (GWG) for their pre-pregnancy body mass index (BMI). The goal of the intervention is to help women achieve GWG within the...
What is the current status of trial NCT03880461?
This trial is currently completed. It is a NA study. The enrollment target is 1,335 participants. The study started on 2021-01-21. Estimated completion is 2025-03-31.
What interventions are being tested in trial NCT03880461?
The interventions under investigation include: Lifestyle Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03880461?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03880461's enrollment target sits among peer trials
1,335 75th of 2000 higher than 1,926 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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