Postpartum Wellness (POW)

Preventing Postpartum Depression: Exercise as Medicine

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Depression
• Intervention / Treatment: Behavioral: Exercise intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Division of Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Exercise intervention; eHealth exercise intervention for postpartum women at increased risk of depression
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-3 months
Physical Activity	Device-based (Actigraph-measured) minutes of moderate/vigorous physical activity	0-3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	Self-report measured minutes of moderate/vigorous physical activity	0-3 months and 3-6 months
Physical Activity	Device-based (Actigraph-measured) minutes of moderate/vigorous physical	3-6 months
Depressive symptoms	Continuous measure of depressive symptoms as assessed in 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.	3-6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep	Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) asks about sleep quality during the past month, including questions on sleep duration, sleep disturbance, and use of sleep-inducing medications. A global score, ranging from 0 to 21, is calculated using seven components of sleep. Higher scores indicate poorer sleep quality.	0-3 months and 3-6 months
Mother-infant bonding	The Mother Infant Bonding Scale by Taylor et al will be used to assess mother-infant bonding. Mother Infant Bonding Scale scores range from 0-24. Higher scores indicate worse mother-infant bonding.	0-3 months and 3-6 months
Anxiety	The General Anxiety Disorder Scale (GAD-7) will be used to assess anxiety. GAD-7 scores range from 0-21. A score of 1-4 suggests minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.	0-3 months and 3-6 months
Stress	Perceived stress will be measured using the Perceived Stress Scale (PSS-10). PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. A score of 0-13 suggests low stress, 14-26 moderate stress, and 27-40 high perceived stress.	0-3 months and 3-6 months
Infant development	Ages and Stages questionnaire for 12-month-old infants. The ASQ-3 screens for delays in infant and child development in five domains: communication, gross motor, fine motor, problem-solving, and personal adaptive skills. Scores for each of the five domains range from 0-60 with higher scores indicating typical development.	At 12 months old

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Lyndsay Avalos, PhD, MPH, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Postpartum Depression; Physical activity; eHealth intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 1548855

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No