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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 is a NA study that has completed, run by Iowa State University. The registered enrollment target is 56 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02168647
The ClinicalTrials.gov registry entry for NCT02168647 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Iowa State University, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT02168647 reports 0 study locations.
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.
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