NCT03880461Completed
A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
Cluster Randomized Trial of a Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1335 (actual)
- First submitted
- 13 Mar 2019
- Start date
- 21 Jan 2021
- Primary completion date
- 28 Mar 2024
- Lead sponsor
- Kaiser Permanente
- Diseases
- Obesity
- NCT number
- NCT03880461
What you commit to
- Study type: Interventional
- Participants enrolled: 1335
- From 21 Jan 2021 to the primary completion date, 28 Mar 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 21 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaiser Permanente-Oakland Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
| Kaiser Permanente-Redwood City Coordinator of this site? Confirm its status | Redwood City | United States | Unknown status |
| Kaiser Permanente-San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Kaiser Permanente Santa Clara Coordinator of this site? Confirm its status | Santa Clara | United States | Unknown status |
Related publications
- Adaptive Mobile Health Intervention to Reduce Excess Gestational Weight Gain: A Cluster-Randomized Clinical Trial.JAMA Netw Open · 2026 · PMID 42008264
This page is information, not medical advice. Discuss any trial with your doctor.