Single session CBT-Informed Treatment for Loss of Control Eating during Pregnancy: A Pilot Feasibility Study

Affecting 50% of pregnant women in the US, excess gestational weight gain (eGWG) has broad and lasting adverse impacts on both maternal and child health. A potentially key modifiable target for the prevention of eGWG is loss-of-control (LOC) eating, a disordered eating behavior characterized by the perceived experience of being unable to control what or how much one is eating, regardless of the amount of food consumed. There is a strong evidence base supporting cognitive-behavioral therapy (CBT) approaches for reducing LOC eating, yet there are currently no pregnancy-focused interventions that target LOC eating. However, CBT can be resource-intensive, costly, lasts several months in duration, and often requires providers with specialized training. Given these critical challenges, developing novel, brief, and evidence-based approaches to targeting LOC eating during pregnancy is a crucial step towards addressing eGWG. Virtual single-session interventions (SSI) that deliver the central theory-driven components of longer interventions represent an innovative approach that balances time and resources with public health impact, yet have not been adapted for LOC eating or pregnancy. To fill this gap, I desire to become a leading independent investigator with a research program focused on the development, implementation, and evaluation of interventions to prevent and treat eating and weight behaviors, but require additional training. The NIH Mentored-Patient Oriented Career Development Award will provide protected time to seek this training and further my skills and ability to implement the proposed research. My short-term training goals are to develop advanced expertise in (1) mixed-methods and qualitative research design, (2) implementation science theory and methods, (3) clinical trial design and implementation. I have developed a strong training plan and mentoring team, led by Drs. Marian Tanofsky-Kraff (co-primary mentor), Jason Lavender (co-primary mentor), Jessica Schleider (mentor), and Paige McDonald (mentor), and a team of expert consultants. RESEARCH STRATEGY: The objective of the study is to design and evaluate the acceptability and preliminary efficacy of a virtual CBT-informed SSI for LOC eating during pregnancy. The study will follow the Knowledge-to-Action Framework that guides implementation science to conduct a two study proposal. Study 1: I will engage pregnant women who experience LOC eating to identify barriers and facilitators to detecting and treating LOC eating, and use their input to design a virtual SSI. Study 2: Participants will be randomized to either the SSI or an information-only condition. This training and research plan will form the basis for a future clinical trial testing the efficacy of the SSI for improving LOC eating and weight outcomes during pregnancy, to be proposed in an R01 grant application before the end of the K23 award. Project Number: 1K23HD118249-01 | Fiscal Year: 2025 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: Katherine Thompson | Institution: METIS FOUNDATION, San Antonio, TX | Award Amount: $161,735 | Activity Code: K23 | Study Section: Health, Behavior, and Context Study Section[CHHD-M] View on NIH RePORTER: https://reporter.nih.gov/project-details/1K23HD11824901