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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gestational Weight Gain

Postnatal Care

Secondary study objectives

Adherence to prescribed goals

Adherence to text-based self- monitoring

Other study objectives

Delivery type

Fetal growth abnormalities

Pregnancy Complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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