Ohio State University
The purpose of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of a 16-week, fully remote, multimodal intervention combining exogenous ketone supplementation (Qitone™) with group-mediated cognitive behavioral (GMCB) counseling with structured exercise for women diagnosed with postpartum depression (PPD). The study aims to determine whether integrating biochemical, behavioral, and physical activity strategies can improve depressive symptoms, metabolic health, and psychosocial functioning during the postpartum period.
Inclusion Criteria: * Participants must meet all of the following criteria to be eligible for enrollment: Identify as female and are between 18-45 years of age. Are within 12 months postpartum following a live birth. Have a clinical diagnosis of Postpartum Depression (PPD) confirmed by a healthcare provider and/or an EPDS score ≥10 at screening. Are medically cleared by their healthcare provider for light-to-moderate physical activity. Are willing and able to participate in virtual group exercise sessions (2× weekly) and behavioral counseling sessions (1× weekly) for 16 weeks. Are willing to…
Participants will consume Qitone exogenous ketone supplement orally twice daily for 16 weeks. Supplements will be pre-packaged and labeled with identification codes to maintain blinding. Adherence will be monitored through self-report logs and returned packaging counts.
Participants will consume an inert placebo beverage orally twice daily for 16 weeks. The placebo will be matched to the Qitone supplement in appearance and taste. It will be pre-packaged and labeled with identification codes to maintain blinding. Adherence will be monitored through self-report logs and returned packaging counts.
Participants will attend one 30-45-minute virtual Group-Mediated Cognitive Behavioral counseling session per week for 16 weeks. Sessions will be led by trained behavioral specialists and emphasize group support, cognitive reframing, self-regulation, motivation, and adherence to exercise and nutrition recommendations. Content will progress through intensive, transition, and maintenance phases.
Participants will attend two 30-minute virtual group exercise sessions per week for 16 weeks. Sessions will combine resistance and interval-based training led by certified instructors. Exercise intensity and progression will be individualized based on perceived exertion and postpartum safety. Participants will also be encouraged to achieve at least 150 minutes of moderate-to-vigorous physical activity per week.
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