Clinical trial NCT04414696: Postpartum Wellness
Official title: Preventing Postpartum Depression: Exercise as Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Keywords: Exercise
Postpartum Depression
Physical activity
eHealth intervention
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Depression symptoms
timeFrame: 0-3 months
measure: Physical Activity
timeFrame: 0-3 months
Secondary outcomes:
measure: Physical Activity
timeFrame: 0-3 months and 3-6 months
measure: Physical Activity
timeFrame: 3-6 months
measure: Depressive symptoms
timeFrame: 3-6 months
Other outcomes:
measure: Sleep
timeFrame: 0-3 months and 3-6 months
measure: Mother-infant bonding
timeFrame: 0-3 months and 3-6 months
measure: Anxiety
timeFrame: 0-3 months and 3-6 months
measure: Stress
timeFrame: 0-3 months and 3-6 months
measure: Infant development
timeFrame: At 12 months old
Locations:
city: Oakland
country: United States
facility: Division of Research
state: California
Study officials:
affiliation: Kaiser Permanente
name: Lyndsay Avalos, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: