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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Study of a Randomized Intervention Designed to Increase Exercise in Pregnancy

Clinicaltrials.gov identifier NCT03936283

Recruitment Status Completed

First Posted May 3, 2019

Last update posted May 6, 2019

Study Description

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.

  • Condition or Disease:Gestational Weight Gain
  • Intervention/Treatment: Behavioral: Intervention
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 75 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention
  • Official Title: Development and Testing of a Mobile-health (M-health) Intervention Tool to Help Overweight and Obese Women Achieve Appropriate Gestational Weight Gain
  • Actual Study Start Date: May 2017
  • Actual Primary Completion Date: June 2018
  • Actual Study Completion Date: June 2018
Arms and interventions
Arm Intervention/treatment
Experimental: Lifestyle Intervention
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.
Outcome Measures
  • Primary Outcome Measures: 1. Change in minutes of moderate physical activity as assessed by the Pregnancy Physical Activity Questionnaire (PPAQ) [ Time Frame: Between 12 and 33 weeks of pregnancy ]
    The investigators will assess change in moderate to vigorous physical activity between surveys in pregnancy. The sports and exercise domain encompasses 20 PPAQ activities of moderate intensity (ranging 3 MET to 6 MET) and 2 PPAQ activities of vigorous intensity (6.5 MET and 7 MET). The volumes of all activities in the sports and exercise domain will be summed to arrive at an estimate of overall volume of moderate to vigorous intensity sports and exercise activity, expressed in MET hours per week. Higher levels of activity are generally associated with better outcomes. The distributions of all physical activity variables will be assessed for outliers.
  • Secondary Outcome Measures: 1. Increased knowledge of the current IOM gestational weight gain guidelines [ Time Frame: Between 12 and 33 weeks of pregnancy ]
    Knowledge of the current IOM GWG guidelines (according to a woman's pre-pregnancy BMI) is assessed during two surveys in pregnancy. If the lower and upper bound provided by the patient are equivalent to or fall within the IOM recommendation bounds, then this will be classified as a match.
Eligibility Criteria
  • Ages Eligible for Study: 21 to 45 Years (Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
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 15 weeks' gestation at enrollment.

Contacts and Locations
Contacts
Locations

United States, California
Kaiser Permanente Northern California
Oakland

Sponsors and Collaborators

Kaiser Permanente

Investigators

Principal Investigator: Monique M Hedderson, Ph.D. Kaiser Permanente

More Information
  • Responsible Party: Kaiser Permanente
  • ClinicalTrials.gov Identifier: NCT03936283 History of Changes
  • Other Study ID Numbers: 1278778-12
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: May 6, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Kaiser Permanente: lifestyle
    intervention
    body weight
    pregnancy
    Overweight
    Signs and Symptoms
    Body weight changes
    Obesity
  • Additional relevant MeSH terms: Weight Gain Gestational Weight Gain