Postpartum Wellness

NCT04414696 | Completed Results

• 1 other identifier: 1548855
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Keywords

Exercise; Postpartum Depression; Physical activity; eHealth intervention

Outcome Measures

Primary Outcomes (2)

• Depression Symptoms

  Continuous measure of depressive symptoms as assessed using the Patient Health Questionnaire (PHQ-8). PHQ-8 scores range from 0-24. A score of 1-4 suggests minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-24 severe depression.

  3 months

• Device-Measured Physical Activity

  Actigraph-measured minutes of moderate/vigorous physical activity

  3 months

Secondary Outcomes (4)

• Self-reported Physical Activity

  3 months

• Device-measured Physical Activity

  6 months

• Depressive Symptoms

  6 months

• Self-reported Physical Activity

  6 months

Other Outcomes (5)

• Sleep

  3 months

• Mother-infant Bonding

  3 months

• Anxiety

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Exercise intervention

Usual Care

NO INTERVENTION

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.

Interventions

Exercise intervention BEHAVIORAL

eHealth exercise intervention for postpartum women at increased risk of depression

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Division of Research

Oakland, California, 94612, United States

Location

Related Publications (1)

• 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.

  PMID: 39470705 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Motor Activity

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Lyndsay Avalos
• Organization: Kaiser Permanente

lyndsay.a.avalos@kp.org

5108210300

Study Officials

• Lyndsay Avalos, PhD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The Investigators and programmers/analysts will be blinded to the intervention assignment. The participants, project manager and research assistant will not be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: November 19, 2020
• Primary Completion: December 13, 2022
• Study Completion: May 1, 2023
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)