NCT04449432

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

December 14, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

3.1 years

First QC Date

June 23, 2020

Last Update Submit

August 4, 2025

Conditions

Pregnancy RelatedGestational Weight GainPostpartum Weight RetentionOverweight and Obesity

Keywords

pregnancygestational weight gainpostpartum weight retentionoverweightobesitydietmHealthdigital health

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Adherence to text-based self- monitoring

    mid-study (25-30 weeks) and post-study (50-55 weeks)

  • Adherence to prescribed goals

    mid-study (25-30 weeks) and post-study (50-55 weeks)

Other Outcomes (3)

  • Delivery type

    mid-study (25-30 weeks)

  • Fetal growth abnormalities

    mid-study (25-30 weeks)

  • Pregnancy complications

    mid-study (25-30 weeks)

Study Arms (2)

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.

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.

Behavioral: Attention Support Control

Interventions

GROWell (Interactive Obesity Treatment Approach)BEHAVIORAL

Personalized messaging via cell phone to support healthy eating behaviors during pregnancy and through 6 months postpartum

GROWell (Interactive Obesity Treatment Approach)
Attention Support ControlBEHAVIORAL

Personalized messaging via cell phone to support healthy behaviors during pregnancy and through 6 months postpartum

Attention Support Control

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis

Davis, California, 95616, United States

Location

Related Publications (2)

  • 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.

    PMID: 36185388DERIVED

  • 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.

    PMID: 34813963DERIVED

Related Links

MeSH Terms

Conditions

Gestational Weight GainOverweightObesity

Condition Hierarchy (Ancestors)

Weight GainBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Leigh Ann Simmons, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Comparing intervention to active control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2020

First Posted

June 26, 2020

Study Start

December 14, 2020

Primary Completion

January 26, 2024

Study Completion

June 30, 2024

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)