Lifestyle Intervention for Pregnancy Weight Gain

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Kaiser Permanente

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

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.

Research Team

Eligibility Criteria

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);

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Exclusion Criteria

Inability to speak, read, or understand English

I am 15 weeks pregnant.

I am currently on bed rest.

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Treatment Details

Interventions

Lifestyle Intervention (Behavioral Intervention)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Lifestyle InterventionExperimental Treatment1 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 - ControlActive Control1 Intervention

Usual Medical Care