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Behavioral Intervention

Interactive Obesity Treatment for Pregnancy

N/A
Waitlist Available
Led By Leigh Ann Simmons, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up mid-study (25-30 weeks) and post-study (50-55 weeks)
Awards & highlights

Study Summary

This trial will establish the efficacy of an mHealth tool, GROWell, for achieving appropriate pregnancy weight gain and promoting postpartum weight loss among women who enter pregnancy overweight or obese.

Who is the study for?
The GROWell trial is for pregnant women who are overweight or obese with a BMI between 25 and 40. Participants should be in their first or early second trimester, not have given birth in the last year, and plan to deliver at UC Davis Medical Center. They must also be able to use text messaging.Check my eligibility
What is being tested?
This study tests the GROWell program, an mHealth tool designed to help manage weight during pregnancy and after giving birth. It will compare the effectiveness of this tool against standard attention support control in promoting healthy weight gain and postpartum weight loss.See study design
What are the potential side effects?
As GROWell is a digital health management tool focusing on education and behavior change rather than medication, it does not have direct medical side effects. However, participants may experience stress or frustration if they do not meet personal goals.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~mid-study (25-30 weeks) and post-study (50-55 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and mid-study (25-30 weeks) and post-study (50-55 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gestational Weight Gain
Postnatal Care
Secondary outcome measures
Adherence to prescribed goals
Adherence to text-based self- monitoring
Other outcome measures
Delivery type
Fetal growth abnormalities
Pregnancy Complications

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GROWell (Interactive Obesity Treatment Approach)Experimental Treatment1 Intervention
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.
Group II: Attention Support ControlActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
914 Previous Clinical Trials
4,720,235 Total Patients Enrolled
30 Trials studying Obesity
33,569 Patients Enrolled for Obesity
Pattern HealthUNKNOWN
National Institute of Nursing Research (NINR)NIH
584 Previous Clinical Trials
10,378,807 Total Patients Enrolled
17 Trials studying Obesity
3,462 Patients Enrolled for Obesity

Media Library

GROWell (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04449432 — N/A
Obesity Research Study Groups: GROWell (Interactive Obesity Treatment Approach), Attention Support Control
Obesity Clinical Trial 2023: GROWell Highlights & Side Effects. Trial Name: NCT04449432 — N/A
GROWell (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04449432 — N/A
~109 spots leftby May 2025
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