Clinical trial NCT03936283: Study of a Randomized Intervention Designed to Increase Exercise in Pregnancy
Official title: Development and Testing of a Mobile-health (M-health) Intervention Tool to Help Overweight and Obese Women Achieve Appropriate Gestational Weight Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Weight Gain
Keywords: lifestyle
intervention
body weight
pregnancy
Overweight
Obesity
Signs and Symptoms
Body weight changes
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 75
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in minutes of moderate physical activity as assessed by the Pregnancy Physical Activity Questionnaire (PPAQ)
timeFrame: Between 12 and 33 weeks of pregnancy
Secondary outcomes:
measure: Increased knowledge of the current IOM gestational weight gain guidelines
timeFrame: Between 12 and 33 weeks of pregnancy
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
Study officials:
affiliation: Kaiser Permanente
name: Monique M Hedderson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas T, Xu F, Sridhar S, Sedgwick T, Nkemere L, Badon SE, Quesenberry C, Ferrara A, Mandel S, Brown SD, Hedderson M. A Web-Based mHealth Intervention With Telephone Support to Increase Physical Activity Among Pregnant Patients With Overweight or Obesity: Feasibility Randomized Controlled Trial. JMIR Form Res. 2022 Jun 22;6(6):e33929. doi: 10.2196/33929.