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Postpartum Wellness (POW)

Primary Purpose

Postpartum Depression

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise intervention
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression focused on measuring Exercise, Postpartum Depression, Physical activity, eHealth intervention

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Physical Activity
Device-based (Actigraph-measured) minutes of moderate/vigorous physical activity

Secondary Outcome Measures

Physical Activity
Self-report measured minutes of moderate/vigorous physical activity
Physical Activity
Device-based (Actigraph-measured) minutes of moderate/vigorous physical
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.

Full Information

First Posted
June 1, 2020
Last Updated
August 4, 2022
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT04414696
Brief Title
Postpartum Wellness
Acronym
POW
Official Title
Preventing Postpartum Depression: Exercise as Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Exercise, Postpartum Depression, Physical activity, eHealth intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The Investigators and programmers/analysts will be blinded to the intervention assignment. The participants, project manager and research assistant will not be masked.
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise intervention
Intervention Description
eHealth exercise intervention for postpartum women at increased risk of depression
Primary Outcome Measure Information:
Title
Depression symptoms
Description
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.
Time Frame
0-3 months
Title
Physical Activity
Description
Device-based (Actigraph-measured) minutes of moderate/vigorous physical activity
Time Frame
0-3 months
Secondary Outcome Measure Information:
Title
Physical Activity
Description
Self-report measured minutes of moderate/vigorous physical activity
Time Frame
0-3 months and 3-6 months
Title
Physical Activity
Description
Device-based (Actigraph-measured) minutes of moderate/vigorous physical
Time Frame
3-6 months
Title
Depressive symptoms
Description
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.
Time Frame
3-6 months
Other Pre-specified Outcome Measures:
Title
Sleep
Description
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.
Time Frame
0-3 months and 3-6 months
Title
Mother-infant bonding
Description
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.
Time Frame
0-3 months and 3-6 months
Title
Anxiety
Description
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.
Time Frame
0-3 months and 3-6 months
Title
Stress
Description
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.
Time Frame
0-3 months and 3-6 months
Title
Infant development
Description
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.
Time Frame
At 12 months old

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndsay Avalos, PhD, MPH
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Research
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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