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

480 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Attention Support Control, GROWell for obesity treatment during pregnancy?

Research shows that lifestyle interventions, including diet and physical activity, can help manage weight gain during pregnancy for women with obesity. These interventions, often delivered through various methods like in-person visits and telehealth, have been effective in helping women gain weight within recommended guidelines, which can improve pregnancy outcomes. ^{1 2 3 4 5}

How is the GROWell treatment for obesity in pregnancy different from other treatments?

The GROWell treatment is unique because it is an interactive approach specifically designed for pregnant women, focusing on lifestyle modifications to manage weight gain during pregnancy, which is not commonly addressed in standard care. ^{6 7 8 9 10}

Research Team

Leigh Ann Simmons, PhD

Principal Investigator

University of California, Davis

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Birthweight and pregnancy outcomes in obese class II women with low weight gain: A retrospective study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Efficacious lifestyle interventions for appropriate gestational weight gain in women with overweight or obesity set in the health care system: a scoping review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Maternal and neonatal outcomes among obese women with weight gain below the new Institute of Medicine recommendations. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Diet, Physical Activity and Gestational Weight Gain Patterns among Pregnant Women Living with Obesity in the North East of England: The GLOWING Pilot Trial. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Optimal Gestational Weight Gain for Women With Obesity. [2023]

6. United States 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. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Obesity and pregnancy: implications and management strategies for providers. [2010]

8. Switzerland 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Obesity in Pregnancy: Optimizing Outcomes for Mom and Baby. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Obesity and Maternal Weight Gain. [2018]