Study of a Randomized Intervention Designed to Increase Exercise in Pregnancy
Study of a Randomized Intervention Designed to Increase Exercise in Pregnancy
This project aims to determine whether a mobile-health (m-health) tool, accessible via
 smartphone or website, intervention for overweight and obese pregnant women improves physical
 activity, gestational weight gain, quality of life, stress and depression during pregnancy.
 This study will examine factors associated with using the m-health tool and the most highly
 utilized features of the tool, with a goal of understanding how it can be used and improved
 in future behavior change interventions. The hypothesis is that compared with usual care, an
 m-health intervention will result in increased minutes of moderate-to-vigorous physical
 activity and increased knowledge of the IOM GWG guidelines. The study design is a small pilot
 randomized trial to assess feasibility. This study will recruit and follow 70 overweight and
 obese pregnant women during the first trimester of pregnancy from Kaiser San Francisco and
 other facilities. The m-health intervention has the advantage of enabling overweight and
 obese women to monitor and improve their health behaviors without impacting the work flow of
 clinical care. Depending on the results of this initial evaluation, the clinical implications
 may include its implementation at the health system level and/or being evaluated and improved
 in the future by a larger investigation in a randomized controlled trial. The study team will
 assess adherence and acceptability of the intervention to inform future studies.
Inclusion Criteria:

 -  Pregnant

 -  Women aged 21 years or older receiving prenatal care at Kaiser Permanente San
 Francisco and Oakland and whose obstetric care clinicians approved their participation
 in the study;

 -  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;

 -  Diagnosis of any of the following conditions: diabetes outside of pregnancy, severe
 disease of the cardio-pulmonary system, serious gastrointestinal disease (e.g.,
 Crohn's disease, IBD), kidney disease, lung disease (e.g., emphysema, COPD), major
 psychiatric disorder, thyroid disease (diagnosed in the last month), cancer (not
 including non-malignant skin cancer), drug and alcohol abuse, or history of an eating
 disorder;

 -  History of bariatric surgery;

 -  Use of metformin or corticosteroids;

 -  Inability to speak, read, or understand English;

 -  Placed on bed rest at time of enrollment;

 -  >15 weeks' gestation at enrollment.