Study Summary
This trial will establish the efficacy of an mHealth tool, GROWell, for achieving appropriate pregnancy weight gain and promoting postpartum weight loss among women who enter pregnancy overweight or obese.
- Overweight and Obesity
- Postpartum Weight Retention
- Gestational Weight Gain
- Maternal Weight Gain
- Pregnancy
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 2 Secondary · Reporting Duration: mid-study (25-30 weeks) and post-study (50-55 weeks)
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Attention Support Control
1 of 2
GROWell (Interactive Obesity Treatment Approach)
1 of 2
Active Control
Experimental Treatment
480 Total Participants · 2 Treatment Groups
Primary Treatment: GROWell (Interactive Obesity Treatment Approach) · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 44 · Female Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Simmons, Leigh Ann, Jennifer E. Phipps, Courtney Overstreet, Paige M. Smith, Elizabeth Bechard, Siwei Liu, Cheryl Walker, and Devon Noonan. 2022. “Goals for Reaching Optimal Wellness (growell): A Clinical Trial Protocol of a Digital Dietary Intervention for Pregnant and Postpartum People with Prenatal Overweight or Obesity”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2021.106627.
- Simmons, Leigh Ann, Jennifer E. Phipps, Courtney Overstreet, Paige M. Smith, Elizabeth Bechard, Siwei Liu, Cheryl Walker, and Devon Noonan. 2022. “Goals for Reaching Optimal Wellness (growell): A Clinical Trial Protocol of a Digital Dietary Intervention for Pregnant and Postpartum People with Prenatal Overweight or Obesity”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2021.106627.
- Simmons LA, Phipps JE, Whipps M, Smith P, Carbajal KA, Overstreet C, McLaughlin J, De Lombaert K, Noonan D. From hybrid to fully remote clinical trial amidst the COVID-19 pandemic: Strategies to promote recruitment, retention, and engagement in a randomized mHealth trial. Digit Health. 2022 Sep 25;8:20552076221129065. doi: 10.1177/20552076221129065. eCollection 2022 Jan-Dec.
- 2020. "Goals for Reaching Optimal Wellness: GROWell". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04449432.
Frequently Asked Questions
Are there any opportunities remaining to join this experiment?
"Clinicaltrials.gov reveals that this clinical trail, posted on December 14th 2020 and last updated April 26th 2022, is currently seeking patients to participate." - Anonymous Online Contributor
Are older individuals being included in the enrollment process of this experiment?
"This clinical trial seeks patients between 18 and 44 years of age as per its inclusion criteria. 123 studies are available for minors, while 372 exist to serve adults over 65." - Anonymous Online Contributor
How many individuals have been included in this clinical trial to date?
"Affirmative. The information posted on clinicaltrials.gov demonstrates that this research project is still in the process of patient recruitment, having been first made available to the public on December 14th 2020 and last revised April 26th 2022. 480 participants will be recruited from a single site for this trial." - Anonymous Online Contributor
What criteria must be met for someone to qualify as a participant in this clinical research?
"Each applicant must have a history of gestational weight gain and be within the prescribed age range (18-44) in order to join this clinical trial. The study is accommodating up to 480 participants." - Anonymous Online Contributor