Goals for Reaching Optimal Wellness: GROWell

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Related; Overweight and Obesity; Gestational Weight Gain; Postpartum Weight Retention
• Intervention / Treatment: Behavioral: GROWell (Interactive Obesity Treatment Approach); Behavioral: Attention Support Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William Pacuilla; Phone Number: (530) 754-8280; Email: bpacuilla@ucdavis.edu
• Study Contact Backup: Name: Grace Liu; Phone Number: (530) 754-8323; Email: proposals@ucdavis.edu

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • UC Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GROWell (Interactive Obesity Treatment Approach); 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.	Behavioral: GROWell (Interactive Obesity Treatment Approach); Personalized messaging via cell phone to support healthy eating behaviors during pregnancy and through 6 months postpartum
Active Comparator: Attention Support Control; 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.	Behavioral: Attention Support Control; Personalized messaging via cell phone to support healthy behaviors during pregnancy and through 6 months postpartum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	End of study (50-55 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	mid-study (25-30 weeks) and post-study (50-55 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delivery type	Categorical as cesarean or vaginal delivery	mid-study (25-30 weeks)
Fetal growth abnormalities	categorical as small-for-gestational age, large-for- gestational-age, macrosomia, or none.	mid-study (25-30 weeks)
Pregnancy complications	categorical as gestational diabetes, hypertension, preeclampsia/eclampsia, placental abruption, fetal death, antepartum admission, preterm birth with and without NICU admission, none	mid-study (25-30 weeks)

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: National Institute of Nursing Research (NINR); Duke University; Pattern Health
• Investigators: Principal Investigator: Leigh Ann Simmons, PhD, University of California, Davis

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Learn more or sign up for the study here!

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 26, 2020

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: obesity; overweight; pregnancy; mHealth; digital health; diet; gestational weight gain; postpartum weight retention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight Changes; Overweight; Body Weight; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: 1399548; 1R01NR017659-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No