A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women

NCT03880461 | Completed Results DMC

• 1 other identifier: 1352535-1
• Study Type: interventional
• Target: 1,335
• Locations: 1 country
• Sites: 4

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.

Conditions

Gestational Weight Gain

Keywords

Gestational weight gain; Lifestyle; Intervention; Body weight; Overweight; Obesity; Signs and Symptoms; Body weight changes

Outcome Measures

Primary Outcomes (3)

• Total Gestational Weight Gain (GWG)

  Calculated as last measured pregnancy weight at the time of delivery minus measured weight at 10 gestational weeks

  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)

  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

  From 10 gestational weeks until time of delivery (duration of up to 9 months)

Secondary Outcomes (7)

• Trimester-specific Weekly Rate of GWG

  0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks

• GWG Trajectory Throughout Pregnancy

  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)

  Between 12 weeks and 33 weeks of pregnancy

• Overall Diet Quality According to the Healthy Eating Index-2015 (HEI-2015)

  Assessed at 12 weeks of pregnancy

• Postpartum Weight Retention

  Assessed at 6 weeks postpartum

Study Arms (2)

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.

Behavioral: Lifestyle Intervention

Usual Care - Control

NO INTERVENTION

Usual Medical Care

Interventions

Lifestyle Intervention BEHAVIORAL

Behavioral lifestyle intervention

Lifestyle Intervention

Eligibility Criteria

• Age: 21 Years - 45 Years
• Gender Eligibility Details: This study is only enrolling female participants.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (4)

Kaiser Permanente Oakland

Oakland, California, 94612, United States

Location

Kaiser Permanente Redwood City

Redwood City, California, 94063, United States

Location

Kaiser Permanente San Francisco

San Francisco, California, 94115, United States

Location

Kaiser Permanente Santa Clara

Santa Clara, California, 95051, United States

Location

Related Publications (1)

• 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.

  PMID: 39710337 BACKGROUND

MeSH Terms

Conditions

Gestational Weight Gain; Body Weight; Overweight; Obesity; Signs and Symptoms; Body Weight Changes

Condition Hierarchy (Ancestors)

Weight Gain; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Monique Hedderson, Ph.D.
• Organization: Kaiser Permanente Northern California

monique.m.hedderson@kp.org

925-520-0785

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 19, 2019
• Study Start: January 21, 2021
• Primary Completion: February 22, 2024
• Study Completion: March 31, 2025
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)