Interactive Obesity Treatment for Pregnancy

Overseen By Grace Liu

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Pregnancy complications, Multiple gestation, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 40 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of GROWell, a mobile health tool designed to help pregnant women who are overweight or obese manage weight gain during pregnancy and lose weight postpartum. The tool provides personalized goals, daily support messages, self-monitoring, and skills training, all delivered via text messages. Participants will either use GROWell or receive general pregnancy-related information for comparison. Women who are 10-16 weeks pregnant, have a BMI between 25 and 40, and receive care at UC Davis clinics may be a good fit. As an unphased study, this trial offers participants the chance to contribute to innovative research that could improve health outcomes for pregnant women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the GROWell mHealth tool is safe for use during pregnancy?

Research has shown that the GROWell tool helps pregnant women manage their weight gain. This mobile health tool uses text messages to support personal goals, provide daily encouragement, enable self-monitoring, and offer skills training.

Regarding safety, GROWell poses no physical risk as it is a digital tool and does not involve drugs or medical procedures. Instead, it aids users in making lifestyle and behavior changes, which are generally safe. Studies on similar mobile health tools have shown they are well-tolerated, with few or no side effects reported.

In summary, GROWell offers a digital method for managing weight during pregnancy. It supports healthy habits, making it a low-risk option for those concerned about safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GROWell approach because it offers a personalized and interactive way to manage obesity during pregnancy, unlike traditional methods that often focus on standard diet and exercise advice. GROWell uses Self-regulation Theory to empower expectant mothers through personalized goal setting, daily support messages, behavior self-monitoring with feedback, and skills training, all delivered via text messages. This innovative use of technology and tailored interaction could make it easier for pregnant women to maintain healthy weight goals, potentially leading to better health outcomes for both the mother and baby.

What evidence suggests that the GROWell mHealth tool is effective for managing pregnancy weight gain?

Research has shown that managing weight during pregnancy can reduce health risks for both mothers and babies. One study of over 16,000 women with obesity found that maintaining weight change between losing 2.2 pounds and gaining 8.8 pounds significantly lowered the risk of major health problems in newborns. In this trial, participants may receive the GROWell tool, designed to help manage weight gain during pregnancy by focusing on personal goals, daily support, self-monitoring, and skills training. Early studies suggest that these strategies may help pregnant and postpartum women achieve healthier weight outcomes. While specific results for GROWell are still under investigation, it aims to provide a dedicated tool for weight control during and after pregnancy. Another group in this trial will receive Attention Support Control, which offers information specific to pregnancy, labor, delivery, and early infancy, but not to diet, to reduce potential placebo effects. ^{1 2 4 6 7}

Who Is on the Research Team?

Leigh Ann Simmons, PhD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

10-16 weeks gestation of a confirmed pregnancy (i.e., ultrasound/heartbeat detected)

My BMI is between 25 and 40, and I can receive and respond to texts.

Nulliparous or >12 months since previous birth

Exclusion Criteria

You stopped smoking less than 6 months ago.

Known pregnancy or fetal complications/high-risk status

You currently smoke cigarettes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily text messages with tailored education, problem-solving skills, and support to aid their personalized dietary goals during pregnancy

40 weeks

Weekly virtual interactions via text messages

Postpartum Treatment

Participants continue to receive support and monitoring for postpartum weight loss through text messages

6 months

Weekly virtual interactions via text messages

Follow-up

Participants are monitored for postpartum weight retention and adherence to goals

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attention Support Control
• GROWell

Trial Overview 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.

How Is the Trial Designed?

Group I: GROWell (Interactive Obesity Treatment Approach) Experimental Treatment 1 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 Control Active Control 1 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.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Pattern Health

Collaborator

Trials

1

Recruited

480+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

In a study of 16,808 women with obesity, a gestational weight change of -1 to +4 kg was found to significantly reduce the risk of major neonatal morbidity compared to the current recommended weight gain guidelines.

Women with class II and III obesity may benefit from even lower weight gain during pregnancy, with optimal ranges of -2 to +2 kg and -2 to +3 kg respectively, indicating that tailored weight management strategies could improve maternal and neonatal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal Gestational Weight Gain for Women With Obesity. Bujold, L., Audibert, F., Chaillet, N.[2023]

A pilot study involving 41 pregnant women with overweight or obesity found that a lifestyle modification program delivered via phone did not significantly reduce gestational weight gain compared to standard treatment.

Both the intervention and standard treatment groups had similar outcomes in terms of weight gain during pregnancy and postpartum, suggesting that more intensive or earlier interventions may be needed to effectively manage weight during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial of a Technology-Based Approach for Preventing Excess Weight Gain during Pregnancy among Women with Overweight. Chao, AM., Srinivas, SK., Studt, SK., et al.[2023]

A group antenatal program in New South Wales, Australia, aimed at helping obese pregnant women manage their weight gain showed that 54% of participants either gained the recommended amount of weight or less, indicating potential effectiveness in limiting gestational weight gain.

The study found that women with higher pre-pregnancy BMIs had significantly lower gestational weight gain, suggesting that the program may help obese women achieve better weight management during pregnancy, although more evidence is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gestational weight change in women attending a group antenatal program aimed at addressing obesity in pregnancy in New South Wales, Australia. Raymond, JE., Foureur, MJ., Davis, DL.[2014]

Managing obesity in women of childbearing age is crucial, as it involves optimizing weight and medical conditions before and during pregnancy to ensure both maternal and fetal health.

Maternal obesity can lead to negative metabolic effects in offspring, contributing to a cycle of obesity that can affect future generations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity in Pregnancy: Optimizing Outcomes for Mom and Baby. Dutton, H., Borengasser, SJ., Gaudet, LM., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9044978/

Goals for Reaching Optimal Wellness (GROWell): A clinical ... Outcomes associated with GWG and pregnancy are expected in late 2023, while outcomes on postpartum weight retention GROWell adherence are expected in late 2024.

2. withpower.com withpower.com/trial/phase-gestational-weight-gain-11-2020-21e7d

Interactive Obesity Treatment for Pregnancy In a study of 16,808 women with obesity, a gestational weight change of -1 to +4 kg was found to significantly reduce the risk of major neonatal morbidity ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34813963/

Goals for Reaching Optimal Wellness (GROWell) - PubMed Outcomes associated with GWG and pregnancy are expected in late 2023, while outcomes on postpartum weight retention GROWell adherence are expected in late 2024.

4. nature.com nature.com/articles/s41366-025-01748-y

The effect of methods used in the management of maternal ... The study revealed that methods used in the treatment of maternal obesity may reduce some negative maternal and newborn outcomes.

5. researchgate.net researchgate.net/publication/353366775_Goals_for_Reaching_Optimal_Wellness_GROWell_A_Clinical_Trial_Protocol_of_a_Digital_Dietary_Intervention_for_Pregnant_and_Postpartum_Women_with_Prenatal_Overweight_or_Obesity

(PDF) Goals for Reaching Optimal Wellness (GROWell) Results Intervention and usual‐care participants did not significantly differ in 12‐month mean postpartum weight change (1.1 vs. 1.6 kg, p = 0.5; difference − ...

6. researchgate.net researchgate.net/publication/356417067_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

A clinical trial protocol of a digital dietary intervention ... Goals for Reaching Optimal Wellness (GROWell): A clinical trial protocol of a digital dietary intervention for pregnant and postpartum people with prenatal ...

7. clinicaltrial.be clinicaltrial.be/en/details/54757?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Goals for Reaching Optimal Wellness: GROWell - Clinical T... With Self-regulation Theory as the framework, the Interactive Obesity Treatment Approach Adapted for Pregnancy/Postpartum includes four ...