NCT03880461

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

Cluster Randomized Trial of a Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,335 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: Female
• Age: 21 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gestational Weight Gain

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle Intervention	Behavioral lifestyle intervention

Timeline

• Start date: 2021-01-21
• Primary completion: 2024-02-22
• Completion: 2025-03-31
• First posted: 2019-03-19
• Last updated: 2025-04-18
• Results posted: 2025-04-18

Locations

4 sites across 1 country: United States