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

April 16, 2025 updated by: Kaiser Permanente

Cluster Randomized Trial of a Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women

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 tool 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1335

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612
        • Kaiser Permanente Oakland
      • Redwood City, California, United States, 94063
        • Kaiser Permanente Redwood City
      • San Francisco, California, United States, 94115
        • Kaiser Permanente San Francisco
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Santa Clara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle Intervention
The goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. 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.
Behavioral: Lifestyle Intervention
Behavioral lifestyle intervention
No Intervention: Usual Care - Control
Usual Medical Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Gestational Weight Gain (GWG)
Time Frame: From 10 gestational weeks until time of delivery (duration of up to 9 months)
Calculated as last measured pregnancy weight at the time of delivery minus measured weight at 10 gestational weeks
From 10 gestational weeks until time of delivery (duration of up to 9 months)
Rate of Total GWG
Time Frame: From 10 gestational weeks until time of delivery (duration of up to 9 months)
Calculated as total gestational weight gain / (# of weeks between 10 gestational weeks and the time of delivery)
From 10 gestational weeks until time of delivery (duration of up to 9 months)
Proportion of Women Meeting the Institute of Medicine's GWG Recommendation
Time Frame: From 10 gestational weeks until time of delivery (duration of up to 9 months)
Proportion of women meeting the IOM's GWG recommendation for weekly rate of GWG
From 10 gestational weeks until time of delivery (duration of up to 9 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trimester-specific Weekly Rate of GWG
Time Frame: 0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks
0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks
GWG Trajectory Throughout Pregnancy
Time Frame: From 10 gestational weeks until time of delivery (duration of up to 9 months)
From 10 gestational weeks until time of delivery (duration of up to 9 months)
Change in Moderate to Vigorous Physical Activity (in MET Hrs/Week) as Assessed by the Pregnancy Physical Activity Questionnaire (PPAQ)
Time Frame: Between 12 weeks and 33 weeks of pregnancy
We will assess change in moderate to vigorous physical activity between study assessments in pregnancy. The sports and exercise domain encompasses 10 PPAQ activities of moderate intensity (ranging 3.2 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.
Between 12 weeks and 33 weeks of pregnancy
Overall Diet Quality According to the Healthy Eating Index-2015 (HEI-2015)
Time Frame: Assessed at 12 weeks of pregnancy
The HEI-2015 reflects adherence to the 2015-2020 Dietary Guidelines for Americans; it is comprised of 13 components as well as an overall score. The scoring system ranges from 0 to 100, where higher values indicate a better diet quality.
Assessed at 12 weeks of pregnancy
Postpartum Weight Retention
Time Frame: Assessed at 6 weeks postpartum
Assessed at 6 weeks postpartum
The Proportion of Infants With Appropriate Birthweight (>10th and <90th Percentile of Sex-, Gestational Age-, and Racial/Ethnic-specific Distribution)
Time Frame: Assessed at birth
Assessed at birth
Infant Growth (BMI Z-score)
Time Frame: From birth to 12 months of age
From birth to 12 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2021

Primary Completion (Actual)

February 22, 2024

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

March 13, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1352535-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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