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NCT02904473 · ClinicalTrials.gov registry record · NA
Goals for Reaching Optimum Wellness (GROWell)
A NA study of Pregnant Women, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT02904473: Completed NA study of Pregnant Women, sponsored by Duke University.
NCT02904473 is a NA study of Pregnant Women that has completed, run by Duke University. The registered enrollment target is 34 participants, below the 1,162-participant average among 5 other Pregnant Women trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02904473, a NA study of Pregnant Women, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot study to assess the feasibility, acceptability and preliminary efficacy of the GROWell diet intervention. The objective of this study is to determine whether the GROWell intervention can help transition women from consuming a Western diet to consuming a prudent diet (characterized by consumption of primarily fruits, vegetables, healthy fats, lean proteins, and whole grains) during pregnancy. Efficacy will be measured as change in dietary components, using a Food Frequency Questionnaire (FFQ) at baseline and at a follow up visit at 37 weeks gestation. The GROWell intervention is a mobile health technology that uses interactive text messaging and dietician coaching calls, and may be effective in transitioning pregnant women from a Western to a prudent diet during an approximately 6 month intervention period. GROWell results will be measured against an Attention Support Control (ASC) arm, where participants will receive messaging that is pregnancy rather than diet focused, and a Usual Care (USC) arm, where participants will not receive text messages or study coaching. Results from this study will be used to support a grant submission for a larger study, aiming to investigate the GROWell intervention and prudent diet consumption as preventatives against postpartum depression.
Primary Outcome
Feasibility will be assessed based on the number and percent of women enrolled vs. approached, vs. completing all study assessments.
Conditions Studied
Interventions
- OTHER GROWell
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2016-11 |
| Est. Completion | 2019-08 |
| Phase | NA |
What the finished NCT02904473 record still lists
NCT02904473 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,162-participant average among 5 other Pregnant Women trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Pregnant Women appearing as the primary indexed condition, and to 1 intervention - of which GROWell is the first listed.
NCT02904473 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02904473 about?
NCT02904473 is a clinical study titled "Goals for Reaching Optimum Wellness (GROWell)". This is a pilot study to assess the feasibility, acceptability and preliminary efficacy of the GROWell diet intervention. The objective of this study is to determine whether the GROWell intervention can help transition women from consuming a Western diet to consuming a prudent diet (characterized by...
What is the current status of trial NCT02904473?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2016-11. Estimated completion is 2019-08.
What conditions does trial NCT02904473 study?
This clinical trial studies the following conditions: Pregnant Women.
What interventions are being tested in trial NCT02904473?
The interventions under investigation include: GROWell (OTHER).
Who is sponsoring clinical trial NCT02904473?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02904473 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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