Gestational Weight GainNCT03880461
A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
A study testing Lifestyle Intervention in people with Gestational Weight Gain, run by Kaiser Permanente at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Gestational Weight Gain
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,335 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Jan 2021to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kaiser Permanente Oakland
Oakland, California, 94612
Kaiser Permanente Redwood City
Redwood City, California, 94063
Kaiser Permanente San Francisco
San Francisco, California, 94115
Kaiser Permanente Santa Clara
Santa Clara, California, 95051
About this study
Official title: Cluster Randomized Trial of a Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
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.
- Conditions
- Gestational Weight Gain
- Being tested
- Lifestyle Intervention
- Keywords
- Gestational weight gain, Lifestyle, Intervention, Body weight, Overweight, Obesity, Signs and Symptoms, Body weight changes
- Medical subject headings
- Gestational Weight Gain, Body Weight, Overweight, Obesity, Signs and Symptoms, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
Behavioral lifestyle intervention
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | The goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. 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. Receives: Behavioral: Lifestyle Intervention |
| Usual Care - Control | No intervention | Usual Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Gestational Weight Gain (GWG)
Calculated as last measured pregnancy weight at the time of delivery minus measured weight at 10 gestational weeks
Measured: From 10 gestational weeks until time of delivery (duration of up to 9 months)
Rate of Total GWG
Calculated as total gestational weight gain / (# of weeks between 10 gestational weeks and the time of delivery)
Measured: From 10 gestational weeks until time of delivery (duration of up to 9 months)
Proportion of Women Meeting the Institute of Medicine's GWG Recommendation
Proportion of women meeting the IOM's GWG recommendation for weekly rate of GWG
Measured: From 10 gestational weeks until time of delivery (duration of up to 9 months)
Secondary outcomes (7)
Trimester-specific Weekly Rate of GWG
Measured: 0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks
GWG Trajectory Throughout Pregnancy
Measured: From 10 gestational weeks until time of delivery (duration of up to 9 months)
Change in Moderate to Vigorous Physical Activity (in MET Hrs/Week) as Assessed by the Pregnancy Physical Activity Questionnaire (PPAQ)
We will assess change in moderate to vigorous physical activity between study assessments in pregnancy. The sports and exercise domain encompasses 10 PPAQ activities of moderate intensity (ranging 3.2 MET to 6 MET) and 2 PPAQ activities of vigorous intensity (6.5 MET and 7 MET). The volumes of all activities in the sports and exercise domain will be summed to arrive at an estimate of overall volume of moderate to vigorous intensity sports and exercise activity, expressed in MET hours per week. Higher levels of activity are generally associated with better outcomes. The distributions of all physical activity variables will be assessed for outliers.
Measured: Between 12 weeks and 33 weeks of pregnancy
Overall Diet Quality According to the Healthy Eating Index-2015 (HEI-2015)
The HEI-2015 reflects adherence to the 2015-2020 Dietary Guidelines for Americans; it is comprised of 13 components as well as an overall score. The scoring system ranges from 0 to 100, where higher values indicate a better diet quality.
Measured: Assessed at 12 weeks of pregnancy
Postpartum Weight Retention
Measured: Assessed at 6 weeks postpartum
The Proportion of Infants With Appropriate Birthweight (>10th and <90th Percentile of Sex-, Gestational Age-, and Racial/Ethnic-specific Distribution)
Measured: Assessed at birth
Infant Growth (BMI Z-score)
Measured: From birth to 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start21 Jan 2021
- Primary completion28 Mar 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational Weight GainStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880461
- Sponsor's protocol ID
- 1352535-1
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2019
- Last updated
- 29 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sridhar SB, Ferrara A, Brown SD, Quesenberry CP, Xu F, Liu E, Sedgwick T, Kissel P, Serrato Bandera HD, Albright C, Hedderson MM. Protocol of an adaptive mobile health intervention for the management of gestational weight gain: The LEAP cluster randomized controlled trial. Contemp Clin Trials. 2025 Feb;149:107781. doi: 10.1016/j.cct.2024.107781. Epub 2024 Dec 20.
PubMed 39710337Hedderson MM, Brown SD, Quesenberry CP, Xu F, Liu EF, Li KL, Sridhar SB, Sedgwick T, Kissel P, Bandera HDS, Bhalala MM, Albright CL, Ferrara A. Adaptive Mobile Health Intervention to Reduce Excess Gestational Weight Gain: A Cluster-Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e268007. doi: 10.1001/jamanetworkopen.2026.8007.
PubMed 42008264
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Trial of a Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
- ClinicalTrials.gov ID
- NCT03880461
- Acronym / sponsor ID
- 1352535-1
- Conditions
- Gestational Weight Gain
- Keywords
- Gestational weight gain, Lifestyle, Intervention, Body weight, Overweight, Obesity, Signs and Symptoms, Body weight changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,335 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Posted 18 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle InterventionThe goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. 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. |
| Usual Care - Control | No intervention | –Usual Medical Care |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle InterventionBehavioral lifestyle intervention | Behavioural | Lifestyle Intervention |
Primary outcome
Total Gestational Weight Gain (GWG)
Time frame: 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
Rate of Total GWG
Time frame: 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)
Proportion of Women Meeting the Institute of Medicine's GWG Recommendation
Time frame: 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
7 secondary outcomes
Trimester-specific Weekly Rate of GWG
Time frame: 0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks
GWG Trajectory Throughout Pregnancy
Time frame: From 10 gestational weeks until time of delivery (duration of up to 9 months)
Change in Moderate to Vigorous Physical Activity (in MET Hrs/Week) as Assessed by the Pregnancy Physical Activity Questionnaire (PPAQ)
Time frame: Between 12 weeks and 33 weeks of pregnancy
Overall Diet Quality According to the Healthy Eating Index-2015 (HEI-2015)
Time frame: Assessed at 12 weeks of pregnancy
Postpartum Weight Retention
Time frame: Assessed at 6 weeks postpartum
The Proportion of Infants With Appropriate Birthweight (>10th and <90th Percentile of Sex-, Gestational Age-, and Racial/Ethnic-specific Distribution)
Time frame: Assessed at birth
Infant Growth (BMI Z-score)
Time frame: From birth to 12 months of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 39710337Sridhar SB, Ferrara A, Brown SD, Quesenberry CP, Xu F, Liu E, Sedgwick T, Kissel P, Serrato Bandera HD, Albright C, Hedderson MM. Protocol of an adaptive mobile health intervention for the management of gestational weight gain: The LEAP cluster randomized controlled trial. Contemp Clin Trials. 2025 Feb;149:107781. doi: 10.1016/j.cct.2024.107781. Epub 2024 Dec 20.
- Derived from this study: PubMed 42008264Hedderson MM, Brown SD, Quesenberry CP, Xu F, Liu EF, Li KL, Sridhar SB, Sedgwick T, Kissel P, Bandera HDS, Bhalala MM, Albright CL, Ferrara A. Adaptive Mobile Health Intervention to Reduce Excess Gestational Weight Gain: A Cluster-Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e268007. doi: 10.1001/jamanetworkopen.2026.8007.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Gestational Weight Gain, run by Kaiser Permanente at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Gestational Weight Gain (GWG) (time frame: From 10 gestational weeks until time of delivery (duration of up to 9 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03880461, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.