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Completed

NCT Number: NCT04414696

Postpartum Wellness

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.

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Key information

Conditions

Postpartum Depression Behavior Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Motor Activity Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Division of Research

Oakland, California, 94612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention

Behavioral

eHealth exercise intervention for postpartum women at increased risk of depression

Primary outcomes

  1. Depression Symptoms

    Time frame: 3 months

    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.

  2. Device-Measured Physical Activity

    Time frame: 3 months

    Actigraph-measured minutes of moderate/vigorous physical activity

Secondary outcomes

  1. Self-reported Physical Activity

    Time frame: 3 months

    Self-reported moderate/vigorous physical activity

  2. Device-measured Physical Activity

    Time frame: 6 months

    Actigraph-measured minutes of moderate/vigorous physical

  3. Depressive Symptoms

    Time frame: 6 months

    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.

  4. Self-reported Physical Activity

    Time frame: 6 months

    Self-reported moderate/vigorous physical activity

Other outcomes

  1. Sleep

    Time frame: 3 months

    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.

  2. Mother-infant Bonding

    Time frame: 3 months

    The Mother Infant Bonding Scale will be used to assess mother-infant bonding.

    Mother Infant Bonding Scale scores range from 0-24. Higher scores indicate worse mother-infant bonding.

  3. Anxiety

    Time frame: 3 months

    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.

  4. Stress

    Time frame: 3 months

    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.

  5. Infant Development

    Time frame: At 12 months old

    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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

Preventing Postpartum Depression: Exercise as Medicine

Acronym: POW

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 4, 2020
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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