Adults 21 to 45, female only, with Gestational Weight Gain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Total Gestational Weight Gain (GWG)Primary· 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
Group
Value
95% CI
Intervention Arm - PATIENTS
10.5
± 5.7
Usual Care Arm - PATIENTS
11.3
± 5.9
Rate of Total GWGPrimary· 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)
Group
Value
95% CI
Intervention Arm - PATIENTS
0.26
± 0.17
Usual Care Arm - PATIENTS
0.28
± 0.16
Proportion of Women Meeting the Institute of Medicine's GWG RecommendationPrimary· 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
Group
Value
95% CI
Intervention Arm - PATIENTS
172
Usual Care Arm - PATIENTS
126
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse outcome data were collected during pregnancy from enrollment to delivery (duration of up to 9 months)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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· enrolling by invitation
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kaiser Permanente
Last refreshed: 18 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03880461.