A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03880461 |
Recruitment Status :
Recruiting
First Posted : March 19, 2019
Last Update Posted : November 12, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gestational Weight Gain | Behavioral: Lifestyle Intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2040 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Cluster Randomized Trial of a Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women |
Actual Study Start Date : | October 1, 2020 |
Estimated Primary Completion Date : | July 14, 2023 |
Estimated Study Completion Date : | June 28, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Lifestyle Intervention
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.
|
Behavioral: Lifestyle Intervention
Behavioral lifestyle intervention |
No Intervention: Usual Care - Control
Usual Medical Care
|
- Total gestational weight gain (GWG) [ Time Frame: From 10 gestational weeks until delivery (approximately 40 gestational weeks) ]
- Rate of total GWG [ Time Frame: From 10 gestational weeks until delivery (approximately 40 gestational weeks) ]
- Proportion of women meeting the Institute of Medicine's GWG recommendation [ Time Frame: From 10 gestational weeks until delivery (approximately 40 gestational weeks) ]
- 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 delivery (approximately 40 gestational weeks) ]
- 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 ]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.
- Overall diet quality according to the Healthy Eating Index-2015 (HEI-2015) [ Time Frame: Assessed at 12 weeks of pregnancy ]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.
- 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 6 months of age ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | This study is only enrolling female participants. |
Accepts Healthy Volunteers: | No |
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 <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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880461
Contact: Monique M Hedderson, Ph.D. | (510) 891-3580 | Monique.M.Hedderson@kp.org |
United States, California | |
Kaiser Permanente Oakland | Recruiting |
Oakland, California, United States, 94612 | |
Kaiser Permanente San Francisco | Recruiting |
San Francisco, California, United States, 94115 |
Responsible Party: | Kaiser Permanente |
ClinicalTrials.gov Identifier: | NCT03880461 |
Other Study ID Numbers: |
1352535-1 |
First Posted: | March 19, 2019 Key Record Dates |
Last Update Posted: | November 12, 2020 |
Last Verified: | November 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Gestational weight gain Lifestyle Intervention Body weight |
Overweight Obesity Signs and Symptoms Body weight changes |
Body Weight Overweight Weight Gain Gestational Weight Gain Body Weight Changes |