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

  • STATUS
    Recruiting
  • End date
    Jun 28, 2024
  • participants needed
    2040
  • sponsor
    Kaiser Permanente
Updated on 3 April 2021

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 tools 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.

Details
Condition Gestational Weight Gain
Treatment Lifestyle intervention
Clinical Study IdentifierNCT03880461
SponsorKaiser Permanente
Last Modified on3 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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