The ACTyourCHANGE study protocol: promoting a healthy lifestyle in patients with obesity with Acceptance and Commitment Therapy-a randomized controlled trial.

BACKGROUND: As treatment of choice in promoting psychological flexibility, Acceptance and Commitment Therapy (ACT) was found to be effective in several conditions, and among different populations, including weight management in individuals with obesity. However, the mechanism of action of psychological flexibility is less known. The aim of the present study is, within the context of a brief ACT intervention for behavioral change and behavioral maintenance of a healthy lifestyle in a sample of inpatients with obesity, to explore the effect of each subcomponent of the psychological flexibility model on treatment processes and outcomes. METHODS: A randomized controlled trial will be conducted. Ninety Italian adult inpatients with obesity attending a rehabilitation program for weight loss will be randomly allocated into three experimental conditions targeting respectively each subcomponent of the psychological flexibility model: group Engage focused on values-oriented behaviors, group Openness focused on acceptance and cognitive defusion, and group Awareness focused on being present and aware of thoughts, feelings, and behaviors at every moment. Weight, BMI (kg/m2), the Psychological General Well-Being Inventory (PGWBI), the Outcome Questionnaire-45.2 (OQ-45.2), the Depression Anxiety and Stress Scale (DASS-21), the Difficulties in Emotion Regulation Scale (DERS), the Dutch Eating Behaviors Questionnaire (DEBQ), the Brief Values Inventory (BVI), the Committed Action Questionnaire (CAQ), the Italian-Cognitive Fusion Questionnaire (I-CFQ), the Five Facet Mindfulness Questionnaire (FFMQ), and the Acceptance and Action Questionnaire (AAQ-II) will be assessed at the beginning (time 0), at the end of psychological intervention (time 1), and after 3 (time 2) and 6 months (time 3) and 9 months (time 4) from discharge. During the following month after discharge, outpatients will be monitored in their adherence to a healthy lifestyle, using a wearable device. To assess the effectiveness of the intervention, mixed between-within 3 (conditions) × 4 (times) repeated measure ANOVAs will be conducted to examine changes from time 0 to time 1, 2, 3, and 4 in means of weight, BMI, and means of scores PGWBI, OQ-45.2, DASS, DERS, DEBQ, AAQ-II, BVI, CAQ, I-CFQ, and FFMQ, between three groups. DISCUSSION: This study will contribute to clarify the mechanism of action of each subcomponent of the psychological flexibility model and understand its impact on the promotion of a healthy lifestyle. TRIAL REGISTRATION: ClinicalTrials.gov NCT04474509 . Registered on July 4, 2020.

ACTonHEALTH study protocol: promoting psychological flexibility with activity tracker and mHealth tools to foster healthful lifestyle for obesity and other chronic health conditions.

BACKGROUND: Obesity and the state of being overweight are increasing steadily and becoming a global epidemic. Recent research reports 64% of the adult population as overweight in Europe and the USA. The social and economic impacts are increasing, and most of the rehabilitation programs, while effective in the short term, do not produce long-lasting results. An explanatory model from a behavioral perspective can describe the phenomena with the lack of sources of reinforcement related to healthful habits in a daily life context. METHODS/DESIGN: A randomized clinical trial combining single-subject studies and a four-arm group design will be conducted to compare the effect of the current standard in obesity treatment to Acceptance and Commitment Therapy (ACT) and wearable technology at different times, before starting intervention, at the end, and at follow-up visits of 3, 6, and 12 months measuring changes over time of physical activity and psychological well-being. DISCUSSION: The goal of this project, combining ACT and wearable technology, is to develop an effective intervention, efficient and sustainable, which even after discharge can provide adequate contingencies of reinforcement in the natural environment, integrating systematic measurements, continuous feedback, and individualized, values-based objectives. The intervention is aimed to provide a contingent reinforcement for healthful behaviors instead of reinforcing only the achievement of a significant weight loss. The aim of the project, combining Acceptance and Commitment Therapy and Wearable Technology, is to develop an effective, efficient and sustainable intervention able to provide a contingent reinforcement for healthy behaviors. The intervention is aimed to promote adequate healthy behaviors in the natural environment, integrating systematic measurements, continuous feedback and individualized values-based objectives, instead of reinforcing only the achievement of a significant weight loss. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03351712 . Registered on 24 November 2017.