Rationale, design, and baseline data for the Healthy Mom II Trial: A randomized trial examining the efficacy of exercise and wellness interventions for the prevention of postpartum depression

Approximately 13–19% of women experience postpartum depression and approximately one-third of women who have a history of depression develop depression during the postpartum phase. Exercise is an efficacious intervention for depression among adults; however, few studies have examined the effect of exercise on postpartum depression. The purpose of this study was to conduct a randomized controlled trial examining the effect of exercise and wellness interventions on preventing postpartum depression among women at risk. Specifically, women (n = 450) who were on average 4.35 weeks postpartum and had a history of depression were randomly assigned to one of the following three conditions: (1) Telephone-based exercise intervention; (2) telephone-based wellness/support intervention (covered topics such as sleep, stress, and healthy eating); or (3) usual care. Both interventions lasted six months. The exercise intervention was based on social cognitive theory and the Transtheoretical model and was specifically designed to motivate postpartum women to exercise. The primary dependent variable was depression based on the Structured Clinical Diagnostic Interview (SCID). Secondary dependent variables included the Edinburgh Postnatal Depression Scale, PHQ-9, and Perceived Stress Scale. Potential mediator variables included quality of sleep, postpartum social support, fatigue, and exercise attitudes. Questionnaires were administered at baseline, six, and nine months. The purpose of this paper is to summarize the methodology, study design, and baseline data for this study. This trial will provide important information regarding the efficacy of exercise and wellness interventions for preventing postpartum depression.