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Study of a Randomized Intervention Designed to Increase Exercise in Pregnancy

NCT03936283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2019-05-06

No results posted yet for this study

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.

Conditions

  • Gestational Weight Gain

Interventions

BEHAVIORAL

Intervention

The goal of the intervention is to help women increase their minutes of moderate-to-vigorous physical activity and to increase their knowledge of the IOM gestational weight gain guidelines. The lifestyle intervention will be delivered through telephone counseling sessions with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and core lifestyle intervention sessions.

Sponsors & Collaborators

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Monique M Hedderson, Ph.D. · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2018-06-26
Completion
2018-06-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03936283 on ClinicalTrials.gov