Kg-Free: an Acceptance, Mindfulness and Compassionate-based Intervention for Women Struggling With Their Weight
Kg-Free: an Acceptance, Mindfulness and Compassionate-based Intervention for Women Struggling With Their Weight
This study aims to test the efficacy and feasibility of an acceptance, mindfulness and
 compassionate-based intervention for women with overweight and obesity without binge-eating
 disorder (Kg-Free). Kg-Free intervention comprises 10 weekly group sessions plus 2 booster
 fortnightly sessions (31/2months) 2h30 hours each, run in small groups at Coimbra's
 University Hospital. The main goal of Kg-Free intervention is to reduce weight self-stigma
 and unhealthy eating behaviours and promote quality-of-life by targeting weight-related
 experiential avoidance and self-criticism patterns. The intervention focuses on fostering a
 greater awareness and ability to be in contact, tolerate and accept all internal experiences
 (even the unwanted ones, such as craving for food, fatigue, stigma and shame), rather than
 trying to avoid, control or change them. Additionally, the intervention intents for
 participant's to develop a compassionate attitude towards themselves, especially during
 challenging times in order to decrease shame and self-criticism.
This project aims to develop and test the efficacy of an integrated intervention (Kg-FREE),
 based on different and complementary approaches from the 3rd generation therapies (Acceptance
 and commitment therapies - ACT, Mindfulness and Compassion Focused Therapy) that have been
 showing promising results individually, but that were never tested simultaneously in
 intervention for people struggling with their eating and weight. Moreover, the intervention
 aims to act specifically on patients' self-criticism and experiential avoidance patterns in
 order to reduce weight-self-stigma and promote healthy behaviours and quality-of-life.
 Indeed, several studies have been suggesting the crucial role of these emotional regulation
 processes on behavioural modification. This study will investigate the impact of the changes
 in several psychological processes in different obesity dimensions, such as body mass and
 biochemical parameters associated with health risks, eating behaviours, stigma, health and
 quality of life.

 The Kg-FREE intervention encloses 10 weekly group sessions (2, 5 hours/ each), highly
 experiential followed by two 2 booster fortnightly sessions. The intervention is divided into
 several modules, that are applied in a structured way: a) psycho education related to eating
 and physical exercise healthy habits; b) how our brain works and how does this relate to our
 eating and weight; c) Life values identifications to enhance intrinsic motivation; d)
 cognitive fusion and experiential avoidance as maladaptive strategies that underlie the
 psychological suffering, the negative affect (e.g. shame) and self-criticism; e) mindfulness
 exercises as a more adaptive strategy for emotional regulation; f) development of
 self-compassion as an antidote for shame and self-criticism, activating the soothing system
 and deactivating the threat system.

 Kg-Free sessions were carried out by a clinical psychologist with previous training in
 contextual-behavioral therapies and one clinical psychology master student. The intervention
 protocol was built upon pre-existent ACT and mindfulness-based protocols for people with
 eating and weight issues (e.g., Forman et al., 2013; Kristeller & Wolever, 2011; Lillis et
 al., 2009; Tapper et al., 2009). Additionally, and because it has been recognized the
 importance of integrating compassion in behavioural interventions (e.g., Luoma & Platt,
 2015), specially to deal with shame and self-criticism (Gilbert, 2010) a compassion component
 was added. This component aimed at training participants to develop a more accepting and kind
 relationship with themselves, particularly when things go wrong or when facing errors or
 failures.

 All session followed the same basic structure, starting with 30 minutes of shared experience,
 followed by a five-minute mindfulness practice. Then the session content was delivered,
 followed by an eating mindfulness practice to train the ability to pay attention to food and
 eating physical sensations. Finally, the session content was briefly revised and practices
 for the week were established (e.g., mindfulness or compassion exercises). A participants'
 manual was provided, which included the targeted constructs, examples and exercise sheets.
 Audio files were given to the participants to ensure the practice of mindfulness and
 compassion exercises between sessions. Moreover, a Portuguese therapist manual was also
 assembled and is available upon request.

 Previously to data collection, ethical approval was obtained from Clinical Trials Unit from
 Coimbra's University Hospital. Participants were adult women, aged between 18 and 55 years
 old, with overweight or obesity (BMI ≥ 25) without binge-eating, enrolled in nutritional
 treatment for weight loss in primary care units and Hospitals from Coimbra's district,
 Portugal. Participants were recruited directly at the medical care units in the day of their
 appointment. Participants were informed about the voluntary and confidential nature of the
 data. Also, a brief overview of the treatment program was presented and participants were
 required to sign the informed consent. In order to assure confidentiality a numerical unique
 code was assigned to each participant.

 After eligibility assessment, participants that meet inclusion criteria were randomly
 assigned into one of the two study conditions - experimental group that will receive the
 Kg-Free intervention and a control group that will maintain Treatment as usual (which
 consisted in dietary and physical activity support), using a using a computer-based random
 allocation. The study followed the principle of treatment received.

 The study comprised four different assessment moments (M0, M1, M2 e M3), namely before
 intervention (M0), at the end of the intervention (M1) and two follow-up moments at three
 (M2) and six months (M3) after the intervention. In all assessments data regarding
 participants' biochemical (lipid profile) and body mass parameters, eating behaviours,
 health, stigma and quality of life as well as psychological processes was collected.
 Regarding biochemical data, the blood samples were collected and analysed by the clinical
 analysis laboratory from the Pharmacy department. Confidentiality was assured hence only the
 research code for each participant was provided to the laboratory. All participants were
 weighted with their street clothes (without shoes) using the same Body Composition Analyzer
 (Tanita TBF-300) accurate to 0.1kg. Waist circumference was measured using a tape measure at
 the umbilicus. The remaining data collection was carried out by clinical psychologists from
 the research team (blinded to participant's treatment condition).

 Statistical analysis All data analyses were performed using Statistical Package for the
 Social Sciences (SPSS, V.20) and alpha level was set at .05. Independent sample t tests were
 used in order to compare intervention and control groups at baseline. Power analysis for
 ANCOVA was calculated at priori. Using a significance level of p<.05 and a power of 80%, a
 sample size of 31 per group (N = 62) was needed to detect a standardized effect size of f =
 0.40.

 To test between-group differences at post-treatment ANCOVA with baseline as covariate and
 condition as a fixed factor were performed. Paired samples t-tests were performed to explore
 within-group differences from pre to post test, for each group separately. All effect sizes
 were calculated using Cohen's d.

 In a second study, Repeated Measures ANOVA was performed to test differences between
 pre-treatment, post- treatment and 3month follow-up assessments for all participant's that
 completed Kg-Free intervention (N = 53). Whenever sphericity assumption was violated, the
 Greenhouse-Geisser correction was used to produce a valid F-ratio. Post-Hoc analyses using
 Bonferroni adjustment for multiple comparisons was used to explore pairwise differences
 (pre-to-post treatment; pre-to-3 months and post-to-3 months). Effect sizes were calculated
 using partial eta square (ƞ2). Finally, to explore the psychological processes that underlie
 the changes in health and weight and eating-related outcomes after the Kg-Free intervention
 MEMORE macro (Mediation and Moderation analysis for Repeated measures designs) was used.
 MEMORE allows for the estimation of total, direct, and indirect effects of independent
 variable (X) on dependent variable (Y) through one or more mediators (M) simultaneously
 two-occasion within-subjects design.
Inclusion Criteria:

 -  Women with overweight or obesity (BMI above 25);

 -  Enrolled in nutritional treatment for weight loss in primary care units and Hospitals
 from Coimbra

 Exclusion Criteria:

 -  Binge Eating Disorder assessed through Eating Disorders Examination Interview;

 -  Severe psychiatric problems (severe depressive episode, substance abuse, Bipolar
 disorder and Borderline Personality Disorder) assessed through Structured Clinical
 Interview for DSM Disorders (SCDI-I and SCID-II);

 -  medical conditions that affect weight;

 -  medication that can cause significant weight or appetite changes.