MedPath

Postpartum Wellness

Not Applicable
Completed
Conditions
Postpartum Depression
Interventions
Behavioral: Exercise intervention
Registration Number
NCT04414696
Lead Sponsor
Kaiser Permanente
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
134
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionExercise interventionParticipants 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.
Primary Outcome Measures
NameTimeMethod
Physical Activity0-3 months

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

Depression symptoms0-3 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.

Secondary Outcome Measures
NameTimeMethod
Depressive symptoms3-6 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.

Physical Activity3-6 months

Device-based (Actigraph-measured) minutes of moderate/vigorous physical

Trial Locations

Locations (1)

Division of Research

🇺🇸

Oakland, California, United States

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