BENITIONSClinical Trial Intelligence

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

N/A Completed NCT03880461

ConditionGestational Weight Gain
PhaseN/A
SponsorKaiser Permanente
StatusCompleted
Enrollment1,335 participants
InterventionsLifestyle Intervention
Start dateJan 21, 2021
Completion dateMar 28, 2024
Results postedApr 18, 2025

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 session

Total Gestational Weight Gain (GWG)

From 10 gestational weeks until time of delivery (duration of up to 9 months) · kilograms

Intervention Arm - PATIENTS10.5 ± 5.7 kilograms
Usual Care Arm - PATIENTS11.3 ± 5.9 kilograms
p-value0.014

Rate of Total GWG

From 10 gestational weeks until time of delivery (duration of up to 9 months) · kilograms/week

Intervention Arm - PATIENTS0.26 ± 0.17 kilograms/week
Usual Care Arm - PATIENTS0.28 ± 0.16 kilograms/week
p-value0.003

Proportion of Women Meeting the Institute of Medicine's GWG Recommendation

From 10 gestational weeks until time of delivery (duration of up to 9 months) · Participants

Intervention Arm - PATIENTS172 Participants
Usual Care Arm - PATIENTS126 Participants
p-value0.108

Open in BENITIONS View on ClinicalTrials.gov

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