Pregnancy RelatedNCT04449432
Goals for Reaching Optimal Wellness: GROWell
A study testing GROWell (Interactive Obesity Treatment Approach) in people with Pregnancy Related and Gestational Weight Gain, run by University of California, Davis at 1 site in United States.
Trial summary
Despite the negative consequences to maternal-child health from women gaining too much weight during pregnancy, up to 62% of overweight and obese women gain more pregnancy weight than is recommended. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Gestational Weight Gain, Postpartum Weight Retention
- What is being tested?
- GROWell (Interactive Obesity Treatment Approach)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2020to 30 Jun 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 10-16 weeks gestation of a confirmed pregnancy (i.e., ultrasound/heartbeat detected)
- Nulliparous or >12 months since previous birth
- Receive care at one of eight UC Davis Obstetric Clinics and plan to deliver at UC Davis Medical Center
- BMI >25 and <40 who are willing to receive and respond to texts using their own cell phone or a study-provided phone
Who cannot join
- Known pregnancy or fetal complications/high-risk status
- Multiple gestation
- Unable to read/write English
- BMI >40
- Current smokers
- Quit smoking <6 months prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Despite the negative consequences to maternal-child health from women gaining too much weight during pregnancy, up to 62% of overweight and obese women gain more pregnancy weight than is recommended. This project will establish the efficacy of Goals for Reaching Optimal Wellness (GROWell), an mHealth tool for achieving appropriate pregnancy weight gain and promoting postpartum weight loss among women who enter pregnancy overweight or obese. GROWell will fill a gap in research and clinical care by providing a validated, standalone mHealth tool for weight control during pregnancy and postpartum, which is a currently lacking resource.
Read the detailed description
Research attempts to prevent excess gestational weight gain, defined as gaining more weight during pregnancy than Institute of Medicine (IOM) guidelines for prepregnancy body mass index (BMI), have largely been unsuccessful. Roughly 62% of overweight and 45% of obese women still gain more weight than recommended, increasing risk for postpartum weight retention. Few mobile health (mHealth) interventions have been trialed to address pregnancy-associated weight gain, which is a missed opportunity. Adult women are high users of technology for general and pregnancy-specific health information seeking and sharing. To fill this gap, the long-term goal of this research is to disseminate into clinical practice a standalone mHealth tool that is effective for overweight and obese pregnant women to achieve gestational weight gain within IOM recommendations and return to prepregnancy weight after childbirth. The goal of this application is to test GROWell: Goals for Reaching Optimal Wellness, an innovative, mHealth tool based on Self-regulation Theory that investigators designed in pilot work to achieve appropriate gestational weight gain and safe postpartum weight loss. The investigators propose a blinded, randomized controlled trial to test the efficacy of GROWell compared to an attention control also developed in a pilot. Investigators will recruit 480 women ages 18-44 with prepregnancy BMI 25-<40 and 10-16 weeks gestation of a singleton, uncomplicated pregnancy. Block randomization based on BMI, race, and recruitment clinic will be used to assign participants equally to arm 1, GROWell (n=240), or arm 2, the attention control (n=240). Upon study enrollment and through 6 months postpartum, GROWell participants will receive daily text messages that provide tailored education, problem-solving skills, and support to aid their personalized dietary goals. Once weekly, participants self-monitor overall adherence to their goals using text messages that prompt them to report on how they did in the past week. When users respond to this prompt, they immediately receive a text with tailored feedback on their adherence and long-term progress toward their goals. Control participants will receive weekly texts that provide personalized self-care, pregnancy, labor, delivery, and early infancy education. The specific aims are to: (1) Compare the efficacy of GROWell to the attention control in reducing the proportion of women who gain excess gestational weight based on IOM guidelines (>25 lbs for overweight and >20 lbs for obese) controlling for demographics, parity, physical activity, diet quality, and depression/anxiety; and (2) Compare the efficacy of GROWell to the attention control in reducing postpartum weight retention at 6 months post-birth as measured by the proportion of women who are within 5% of their prepregnancy weight, controlling for demographics, parity, physical activity, diet quality, breastfeeding, and depression/anxiety. This research addresses PA 18-135 (Maternal Nutrition and Pre-pregnancy Obesity) and will provide an innovative, evidence-based, standalone mHealth tool to reduce excess gestational weight gain and postpartum weight retention among overweight and obese women, currently an unavailable resource.
- Conditions
- Pregnancy Related, Gestational Weight Gain, Postpartum Weight Retention, Overweight and Obesity
- Being tested
- GROWell (Interactive Obesity Treatment Approach), Attention Support Control
- Keywords
- pregnancy, gestational weight gain, postpartum weight retention, overweight, obesity, diet, mHealth, digital health
- Medical subject headings
- Gestational Weight Gain, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GROWell (Interactive Obesity Treatment Approach)Behavioural
Personalized messaging via cell phone to support healthy eating behaviors during pregnancy and through 6 months postpartum
Attention Support ControlBehavioural
Personalized messaging via cell phone to support healthy behaviors during pregnancy and through 6 months postpartum
| Study group | Role | What they receive |
|---|---|---|
| GROWell (Interactive Obesity Treatment Approach) | Experimental | With Self-regulation Theory as the framework, the Interactive Obesity Treatment Approach Adapted for Pregnancy/Postpartum includes four components: (1) personalized goal setting, (2) daily support and educational messages, (3) self-monitoring of behavior with tailored feedback, and (4) skills training. Each component aligns with the self- regulatory processes shown in previous studies to be necessary for behavior change. All interactions with participants are via text using a cell phone. Receives: Behavioral: GROWell (Interactive Obesity Treatment Approach) |
| Attention Support Control | Active comparator | The attention control will be delivered using text messaging to reduce the potential placebo effect that interacting with our mHealth system may have on pregnancy weight gain and postpartum weight loss. Information will be provided to control group participants that is specific to pregnancy, labor, delivery, and early infancy, but not to diet. Texts are specific to the participant's partner, pregnancy, employment, and breastfeeding plans/status. Receives: Behavioral: Attention Support Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational Weight Gain
Gestational weight gain will be calculated as: [weight(delivery) - weight(preconception)]. Women will be categorized as gaining excess gestational weight if they started pregnancy as overweight and gained more than 25 pounds or started pregnancy as obese and gained more than 20 pounds.
Measured: Mid-study (25-30 weeks)
Postpartum Weight Retention
Postpartum weight retention will be calculated as: [weight(6 months postpartum) - weight(preconception)]. Women will be categorized as experiencing postpartum weight retention if postpartum weight at 6 months is greater than 1.05*preconception weight.
Measured: End of study (50-55 weeks)
Secondary outcomes (2)
Adherence to text-based self- monitoring
Measured cumulatively by week as the number of times a participant responds to weekly prompts to report on her progress to the number of times she was prompted, calculated to a percent separately for prenatal and postnatal periods.
Measured: mid-study (25-30 weeks) and post-study (50-55 weeks)
Adherence to prescribed goals
Measured cumulatively by week as the proportion of goals for which a participant has "good adherence" during the previous week, defined as adhering to the goal 5/7 days, or >70%, calculated to a percent and separately for prenatal and postpartum periods.
Measured: mid-study (25-30 weeks) and post-study (50-55 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start14 Dec 2020
- Primary completion26 Jan 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparing intervention to active control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Pattern Health, National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Leigh Ann Simmons, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449432
- Sponsor's protocol ID
- 1399548
- Other IDs
- 1R01NR017659-01A1
- Status last verified
- Aug 2025
- First submitted
- 23 Jun 2020
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simmons LA, Phipps JE, Castro-Alvarez S, Smith P, Overstreet C, Patrikeyeva A, Gilliland P, Keeton VF, Noonan D. A randomized digital behavioral intervention for prenatal and postpartum weight outcomes in women with overweight or obesity: the GROWell trial. BMC Pregnancy Childbirth. 2026 Feb 26;26(1):368. doi: 10.1186/s12884-026-08846-3.
PubMed 41742094Simmons 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.
PubMed 36185388Simmons LA, Phipps JE, Overstreet C, Smith PM, Bechard E, Liu S, Walker C, Noonan D. 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. Contemp Clin Trials. 2022 Feb;113:106627. doi: 10.1016/j.cct.2021.106627. Epub 2021 Nov 20.
PubMed 34813963