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NCT02168647 · ClinicalTrials.gov registry record · NA
The Blossom Project: "Be-Well" Behavioral Wellness Study in Pregnancy
A NA study, sponsored by Iowa State University.
- Completed
- Registry status
- NA
- Development phase
- 56
- Enrollment target
NCT02168647: Completed NA study, sponsored by Iowa State University.
NCT02168647 is a NA study that has completed, run by Iowa State University. The registered enrollment target is 56 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02168647, a NA study, has completed, sponsored by Iowa State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
Study Summary
Multiple studies have demonstrated a very low prevalence of women meeting physical activity and weight gain recommendations during pregnancy. The aim of this study is to provide a lifestyle intervention to increase physical activity, reduce carbohydrate intake, prevent excessive gestational weight gain, decrease postpartum weight retention, and improve mental well-being compared to "usual care" using a randomized controlled design in pregnant women. Participants in the intervention group will receive behavioral lifestyle counseling and take part in monthly one-on-one visits with a registered dietitian (RDN) from approximately week 14 of their pregnancy to child birth. Participants in the "usual care" group (control) will not receive any lifestyle counseling. Data collected from this group will be used to compare the effectiveness of the lifestyle intervention. Unlike many studies examining diet and physical activity factors alone, this study evaluates additional psychosocial factors such as psychological health, self-efficacy, competence, motivation and barriers that may influence excessive gestational weight gain. In addition, the Self-Determination Theory framework will be used to measure how motivation and motivational interviewing strategies can help explain changes in volitional behavior.
Primary Outcome
Gestational weight gain as measured by last pre-delivery weight minus self-reported pre-pregnancy weight. Maternal weight will be measured at each routine prenatal appointment and plotted on the IOM pregnancy weight gain chart. Body composition changes measured by BodPod at baseline and 2 months postpartum.
Interventions
- OTHER Control
- BEHAVIORAL Behavioral Lifestyle counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2015-03 |
| Est. Completion | 2017-10 |
| Phase | NA |
What the finished NCT02168647 record still lists
NCT02168647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT02168647 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02168647 about?
NCT02168647 is a clinical study titled "The Blossom Project: "Be-Well" Behavioral Wellness Study in Pregnancy". Multiple studies have demonstrated a very low prevalence of women meeting physical activity and weight gain recommendations during pregnancy. The aim of this study is to provide a lifestyle intervention to increase physical activity, reduce carbohydrate intake, prevent excessive gestational weight g...
What is the current status of trial NCT02168647?
This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2015-03. Estimated completion is 2017-10.
What interventions are being tested in trial NCT02168647?
The interventions under investigation include: Control (OTHER), Behavioral Lifestyle counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT02168647?
This trial is sponsored by Iowa State University, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02168647's enrollment target sits among peer trials
56 1262nd of 2000 higher than 737 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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