Postpartum Wellness

NCT ID: NCT04414696

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-19
• Study Completion Date: 2023-05-01

Brief Summary

The purpose of this study is to test whether a web-based (eHealth) exercise intervention for new moms at increased risk for postpartum depression increases physical activity and decreases postpartum depression symptoms.

Detailed Description

Postpartum depression is a debilitating and costly condition that is associated with significant health consequences for mothers and children. Counseling for prevention of postpartum depression is currently recommended in women at high risk of postpartum depression; however, there is a shortage of mental health care providers. There is a need for effective interventions to prevent postpartum depression that can be easily integrated into health care systems, yet do not involve intense health care system resources. eHealth interventions are promising in this regard.

Strong evidence suggests physical activity can reduce depression risk. This study will assess the effectiveness of an eHealth exercise intervention tailored to postpartum mothers for increasing physical activity levels and improving depressive symptoms in women at increased risk of postpartum depression. This intervention addresses several identified barriers to physical activity in postpartum women. The study will randomize 200 women to receive an eHealth exercise intervention for postpartum women or usual postpartum care. Device-based physical activity and depressive symptoms will be measured at 3 and 6 months after randomization.

Conditions

Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.

Group Type: EXPERIMENTAL

Exercise intervention

Intervention Type: BEHAVIORAL

eHealth exercise intervention for postpartum women at increased risk of depression

Usual Care

Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise intervention

eHealth exercise intervention for postpartum women at increased risk of depression

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• KPNC member between 2 and 6 months postpartum
• Current PHQ-8 score between 10-20 and no current depression diagnosis
• Delivered baby in KPNC
• English-speaking
• Own a smartphone, computer, or TV with internet access
• Free of a heart condition and a physician recommending medically supervised physical activity
• Body Mass Index (BMI) between 18.5 and 40 (kg/m2)
• A baby weighing between 11-22 lbs

Exclusion Criteria

• Engaged in regular, moderate or vigorous physical activity >90 minutes or more per week
• Pregnant or planning to become pregnant in the ensuing three months
• A baby with chronic illness/disorder(s) that prevent participant from holding or lifting him/her
• Chest pain during physical activity, or has had chest pain within the prior month
• Taking medication for hypertension or a heart condition
• Tendency to fall due to syncope or dizziness
• Orthopedic problems that might be aggravated by physical activity
• Has exercise-induced asthma

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lyndsay Avalos, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Division of Research

Oakland, California, United States

Countries

United States

References

Ramsey M, Oberman N, Quesenberry CP Jr, Kurtovich E, Gomez Chavez L, Chess A, Brown SD, Albright CL, Bhalala M, Badon SE, Avalos LA. A Tailored Postpartum eHealth Physical Activity Intervention for Individuals at High Risk of Postpartum Depression-the POstpartum Wellness Study (POW): Protocol and Data Overview for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 29;13:e56882. doi: 10.2196/56882.

Reference Type: DERIVED

PMID: 39470705 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1548855

Identifier Type: -

Identifier Source: org_study_id