Clinical trial NCT04449432: Goals for Reaching Optimal Wellness: GROWell
Official title: Goals for Reaching Optimal Wellness: GROWell
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy Related
Gestational Weight Gain
Postpartum Weight Retention
Overweight and Obesity
Keywords: pregnancy
gestational weight gain
postpartum weight retention
overweight
obesity
diet
mHealth
digital health
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Duke University
name: Pattern Health
name: National Institute of Nursing Research (NINR)
First posted: 2020-06-26
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparing intervention to active control
Primary purpose: PREVENTION

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Gestational Weight Gain
timeFrame: Mid-study (25-30 weeks)
measure: Postpartum Weight Retention
timeFrame: End of study (50-55 weeks)
Secondary outcomes:
measure: Adherence to text-based self- monitoring
timeFrame: mid-study (25-30 weeks) and post-study (50-55 weeks)
measure: Adherence to prescribed goals
timeFrame: mid-study (25-30 weeks) and post-study (50-55 weeks)
Other outcomes:
measure: Delivery type
timeFrame: mid-study (25-30 weeks)
measure: Fetal growth abnormalities
timeFrame: mid-study (25-30 weeks)
measure: Pregnancy complications
timeFrame: mid-study (25-30 weeks)
Locations:
city: Davis
country: United States
facility: UC Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Leigh Ann Simmons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Simmons 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.