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COMPLETED NA

Goals for Reaching Optimum Wellness (GROWell)

NCT02904473 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

Interventions

  • OTHER GROWell

Study Locations (1)

North Carolina

  • Duke University Medical Center — Durham

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2016-11
Est. Completion 2019-08
Phase NA

Sponsor

Duke University

1,129 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02904473

The ClinicalTrials.gov registry entry for NCT02904473 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02904473 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02904473?

The interventions under investigation include: GROWell (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02904473?

This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial