N/A
N=1,335
A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
Gestational Weight Gain
Bottom Line
View on ClinicalTrials.gov: NCT03880461 ↗Enrolled (actual)
1,335
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Total Gestational Weight Gain (GWG) — 10.5; 11.3 kilograms — p=0.014
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lifestyle Intervention (Behavioral)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Kaiser Permanente
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Gestational Weight Gain (GWG) |
10.5; 11.3 | 0.014 sig |
| PRIMARY Rate of Total GWG |
0.26; 0.28 | 0.003 sig |
| PRIMARY Proportion of Women Meeting the Institute of Medicine's GWG Recommendation |
172; 126 | 0.108 |
| SECONDARY Trimester-specific Weekly Rate of GWG |
— | — |
| SECONDARY GWG Trajectory Throughout Pregnancy |
— | — |
| SECONDARY Change in Moderate to Vigorous Physical Activity (in MET Hrs/Week) as Assessed by the Pregnancy Physical Activity Questionnaire (PPAQ) |
— | — |
| SECONDARY Overall Diet Quality According to the Healthy Eating Index-2015 (HEI-2015) |
— | — |
| SECONDARY Postpartum Weight Retention |
— | — |
| SECONDARY The Proportion of Infants With Appropriate Birthweight (>10th and <90th Percentile of Sex-, Gestational Age-, and Racial/Ethnic-specific Distribution) |
— | — |
| SECONDARY Infant Growth (BMI Z-score) |
— | — |
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.
Eligibility Criteria
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 15 weeks' gestation at enrollment.
Data sourced from ClinicalTrials.gov (NCT03880461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.