CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,335 enrolled
Drug / intervention
Lifestyle Interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03880461
NCT03880461N/ACompleted

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

Kaiser Permanente·interventional·Posted Mar 19, 2019·Updated Apr 18, 2025

In Brief

A clinical study evaluating Lifestyle Intervention for Gestational Weight Gain. Completed, enrolled 1,335 participants across 4 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 19, 2019
Enrollment StartJan 21, 2021
Primary CompletionFeb 22, 2024
Study CompletionMar 31, 2025
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.3 years ago

Interventions

Lifestyle Interventionbehavioral

Behavioral lifestyle intervention