Goals for Reaching Optimal Wellness: GROWell

Overweight and Obesity Clinical Trial

Official title:

Goals for Reaching Optimal Wellness: GROWell

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04449432
• Other study ID #: 1399548
• Secondary ID: 1R01NR017659-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: March 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Overweight
• Overweight and Obesity
• Postpartum Weight Retention
• Pregnancy Related
• Weight Gain

Intervention

Behavioral:
• GROWell (Interactive Obesity Treatment Approach)
Personalized messaging via cell phone to support healthy eating behaviors during pregnancy and through 6 months postpartum
• Attention Support Control
Personalized messaging via cell phone to support healthy behaviors during pregnancy and through 6 months postpartum

Locations

Country	Name	City	State
United States	UC Davis	Davis	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Davis	Duke University, National Institute of Nursing Research (NINR), Pattern Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Delivery type	Categorical as cesarean or vaginal delivery	mid-study (25-30 weeks)
Other	Fetal growth abnormalities	categorical as small-for-gestational age, large-for- gestational-age, macrosomia, or none.	mid-study (25-30 weeks)
Other	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)
Primary	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)
Primary	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	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)
Secondary	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)

External Links

•   Learn more or sign up for the study here!