Goals for Reaching Optimal Wellness: GROWell

NCT04449432 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2025-08-07

No results posted yet for this study

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.

Conditions

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

Interventions

BEHAVIORAL

GROWell (Interactive Obesity Treatment Approach)

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

BEHAVIORAL

Attention Support Control

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

Sponsors & Collaborators

  • Duke University

    collaborator OTHER
  • Pattern Health

    collaborator UNKNOWN
  • National Institute of Nursing Research (NINR)

    collaborator NIH
  • University of California, Davis

    lead OTHER

Principal Investigators

  • Leigh Ann Simmons, PhD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2024-01-26
Completion
2024-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04449432 on ClinicalTrials.gov