A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women

Completed · Not applicable

Conditions studied: Gestational Weight Gain

In brief

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.

Key facts

Study ID

NCT03880461

Run by

Kaiser Permanente

People needed

1335

Starts

2021-01-21

Expected to finish

2025-03-31

Last updated by the study team

2026-07-29

Who can join

Age: 21 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pregnant
• 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);
• Has access to a smartphone and Wi-Fi;
• Provides informed consent to participate.

You may not qualify if…

• Multiple births;
• Planning to move out of the area during the study period;
• Inability to speak, read, or understand English;
• Placed on bed rest at time of enrollment; ->15 weeks' gestation at enrollment.

Where it is running

• Kaiser Permanente Oakland — Oakland, California, United States
• Kaiser Permanente Redwood City — Redwood City, California, United States
• Kaiser Permanente San Francisco — San Francisco, California, United States
• Kaiser Permanente Santa Clara — Santa Clara, California, United States

Full record on ClinicalTrials.gov

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