Lifestyle Intervention for Pregnancy Weight Gain

Recruiting at 3 trial locations

Overseen By Monique M Hedderson, Ph.D.

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Multiple births, Moving, Bed rest, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 9 months

1335 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The aim of this trial is to investigate the effectiveness of a mobile health (mhealth) intervention to help overweight and obese women achieve appropriate gestational weight gain (GWG) for their pre-pregnancy body mass index (BMI). The goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. The investigators propose an adaptive intervention that begins with an effective, yet low resource-intensive treatment and then provides incremental support and resources only to patients who need them. The intervention includes: 1) an mHealth tool allowing data to be automatically transmitted to a mobile website; 2) personalized text messages; and 3) personalized 1:1 telephone coaching sessions. The latter more intensive components are reserved for patients whose GWG is not within the IOM guidelines. The lifestyle intervention will be delivered through 1 telephone counseling session with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and weekly e-mails of core lifestyle intervention sessions. Personalized text messages and 1:1 telephone coaching sessions will be given to those who are not meeting the GWG guidelines. The lifestyle intervention will be compared to usual medical care. Maternal outcomes will be assessed shortly before delivery and at 6 weeks postpartum. Infant birthweight and weight at one year will also be assessed.

Are You a Good Fit for This Trial?

This trial is for overweight or obese pregnant women with a pre-pregnancy BMI of 25 to <40, who are patients at Kaiser Permanente in San Francisco or Oakland. Participants must have access to a smartphone and Wi-Fi, understand English, and not be on bed rest or planning to move during the study.

Inclusion Criteria

Provides informed consent to participate.

Women receiving prenatal care at Kaiser Permanente San Francisco and Oakland and whose obstetric care clinicians consent to participate

Pregravid BMI 25 to <40 (as determined from a measured pregravid weight in electronic medical record);

Exclusion Criteria

Inability to speak, read, or understand English

I am 15 weeks pregnant.

I am currently on bed rest.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a mobile health intervention to achieve appropriate gestational weight gain, including personalized text messages and 1:1 telephone coaching sessions

Up to 9 months

1 telephone counseling session, ongoing virtual support

Follow-up

Maternal outcomes are assessed shortly before delivery and at 6 weeks postpartum. Infant birthweight and weight at one year will also be assessed

6 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle Intervention

Trial Overview The trial tests a mobile health intervention aimed at helping participants maintain pregnancy weight gain within recommended limits. It includes an mHealth tool, personalized texts, and telephone coaching sessions for those not meeting guidelines—compared against usual medical care.

How Is the Trial Designed?

Group I: Lifestyle Intervention Experimental Treatment 1 Intervention

The goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. The lifestyle intervention will be delivered through 1 telephone counseling session with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and weekly e-mails of core lifestyle intervention sessions. Personalized text messages and 1:1 telephone coaching sessions will be given to those who are not meeting the GWG guidelines.

Group II: Usual Care - Control Active Control 1 Intervention

Usual Medical Care

Lifestyle Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Lifestyle Intervention for:

• Obesity
• Weight Loss
• Type 2 Diabetes Prevention

Approved in European Union as Lifestyle Intervention for:

• Obesity
• Overweight
• Weight-Related Diseases

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+