Clinical trial NCT03880461: A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
Official title: Cluster Randomized Trial of a Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Weight Gain
Keywords: Gestational weight gain
Lifestyle
Intervention
Body weight
Overweight
Obesity
Signs and Symptoms
Body weight changes
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-03-19
Enrollment: 1335
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 \<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.

Primary outcomes:
measure: Total Gestational Weight Gain (GWG)
timeFrame: From 10 gestational weeks until time of delivery (duration of up to 9 months)
measure: Rate of Total GWG
timeFrame: From 10 gestational weeks until time of delivery (duration of up to 9 months)
measure: Proportion of Women Meeting the Institute of Medicine's GWG Recommendation
timeFrame: From 10 gestational weeks until time of delivery (duration of up to 9 months)
Secondary outcomes:
measure: Trimester-specific Weekly Rate of GWG
timeFrame: 0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks
measure: GWG Trajectory Throughout Pregnancy
timeFrame: From 10 gestational weeks until time of delivery (duration of up to 9 months)
measure: Change in Moderate to Vigorous Physical Activity (in MET Hrs/Week) as Assessed by the Pregnancy Physical Activity Questionnaire (PPAQ)
timeFrame: Between 12 weeks and 33 weeks of pregnancy
measure: Overall Diet Quality According to the Healthy Eating Index-2015 (HEI-2015)
timeFrame: Assessed at 12 weeks of pregnancy
measure: Postpartum Weight Retention
timeFrame: Assessed at 6 weeks postpartum
measure: The Proportion of Infants With Appropriate Birthweight (>10th and <90th Percentile of Sex-, Gestational Age-, and Racial/Ethnic-specific Distribution)
timeFrame: Assessed at birth
measure: Infant Growth (BMI Z-score)
timeFrame: From birth to 12 months of age
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Oakland
state: California
city: Redwood City
country: United States
facility: Kaiser Permanente Redwood City
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara
state: California
Study officials:
References:
citation: 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.