Postpartum Wellness

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preventing Postpartum Depression: Exercise as Medicine

Conditions
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Postpartum Depression

Intervention / Treatment
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* Behavioral: Exercise intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* eHealth exercise intervention for postpartum women at increased risk of depression<br>|
| No Intervention: Usual Care<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Postpartum Depression, Physical activity, eHealth intervention