Protocol and data overview for the POstpartum Wellness study (POW): A Randomized controlled trial of a tailored postpartum eHealth physical activity intervention for individuals at high risk of postpartum depression (Preprint)

Abstract

Postpartum depression (PPD) is associated with significant health consequences for the parent and child. The current recommendations for PPD prevention require intense healthcare system resources. Strong evidence-based interventions for PPD prevention that do not put additional burden on the health care system are needed. In the general population, strong evidence suggests that physical activity (PA) can reduce depressive symptoms. Additionally, technology-based health interventions are a promising approach for decreasing common barriers to PA.

Here we report the protocol and provide a data overview of the POstpartum Wellness study (POW), an effectiveness trial to evaluate whether an eHealth PA intervention tailored for postpartum individuals increased PA and decreased depressive symptoms among postpartum individuals at high risk of PPD.

We conducted a remote parallel-group randomized controlled trial. We recruited postpartum individuals with a history of depression or at least moderate current depressive symptoms that did not meet the diagnostic threshold for PPD and with low PA levels, from an integrated health care delivery system. Participants were randomized to an eHealth PA intervention or usual care. The eHealth intervention group received access to a library of online workout videos specifically designed for postpartum individuals that included interaction with their infant. At baseline and follow-up at 3 and 6 months, moderate/vigorous intensity PA was measured using questionnaires and a wrist-worn accelerometer. Participants’ depressive symptoms were measured using the Patient Health Questionnaire (PHQ-8). Additional data was collected to assess exploratory outcomes of postpartum sleep, perceived stress, anxiety symptoms, parent-infant bonding, and infant development.

Participants were enrolled online or by phone between November 2020 - September 2022; follow-up data collection ended in April 2023. Randomized participants (N=99) were 4 months postpartum at baseline with moderately severe depressive symptoms (mean [SD] PHQ-8 score=12.6 [2.2]). The intervention (n=50) and usual care (n=49) groups were similar in sociodemographic characteristics, months postpartum, baseline depressive symptoms, number of children at home, and pre-pregnancy PA level. Overall, retention in trial assessments was ≥66% for questionnaires and ≥48% for accelerometry, with some modest differences by condition. At the 3-month follow-up, 73.6% of participants (70% in the intervention, 77.6% in usual care) completed questionnaires; 58.6% returned the accelerometer after wearing it for 7 days (60% intervention, 57.2% usual care). At the 6-month follow-up, 66.7% of participants (60% intervention, 73.5% usual care) completed questionnaires and 48.4% returned the accelerometer after wearing it for 7 days (46% intervention, 51.0% usual care).

The POW trial was designed to evaluate the effectiveness of an eHealth PA intervention for improving depressive symptoms and increasing PA among postpartum individuals at high risk for PPD. Results have implications for the design and delivery of behavioral interventions in a vulnerable patient population.