Goals for Reaching Optimum Wellness (GROWell)
Completed · Not applicable
Conditions studied: Pregnant Women
In brief
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.
Key facts
- Study ID
- NCT02904473
- Run by
- Duke University
- People needed
- 34
- Starts
- 2016-11-01
- Expected to finish
- 2019-08-01
- Last updated by the study team
- 2019-08-15
Who can join
Age: 18 and older, up to 44. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 to 44
- Read and understand English
- Receiving prenatal care at Duke Medicine
- Prepregnancy BMI ≥25 and <35
- Within 14 to <20 weeks gestation
- Singleton, uncomplicated pregnancy [no preexisting diabetes, hypertension, etc.]
- Non-smoking for at least 6 months
- Nulliparous, or >24 months since previous pregnancy
- No current depression as documented in the medical record
- Has a cell phone with texting capability [smartphone not required], and is willing to use it at their expense for study purposes
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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