Kg-Free: an Acceptance, Mindfulness and Compassionate-based Intervention for Women Struggling With Their Weight

NCT02850796 | Completed

• 2 other identifiers: CINEICC-01-LPSFRH/BD/84452/2012
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Overweight and Obesity

Keywords

Mindfulness; self-compassion; Acceptance and Commitment Therapy; weight self-stigma; quality-of-life

Outcome Measures

Primary Outcomes (3)

• Changes in weight self-stigma

  Assessed by Weight self-stigma questionnaire (WSSQ)

  9 months (from Baseline to 6-months follow-up)

• Changes in eating behaviours

  Assessed by the Three Factor Eating Questionnaire (TFEQ-R21)

  9 months (from Baseline to 6-months follow-up)

• Changes in obesity-related quality-of-life

  Assessed by Obesity Related Well-Being Questionnaire (ORWELL)

  9 months (from Baseline to 6-months follow-up)

Secondary Outcomes (4)

• Changes in BMI

  9 months (from Baseline to 6-months follow-up)

• Changes in Lipidic Profile (Total, HDL, LDL Cholesterol and Triglycerides)

  9 months (from Baseline to 6-months follow-up)

• Changes in Physical exercise frequency

  9 months (from Baseline to 6-months follow-up)

• Changes in psychopathological symptoms

  9 months (from Baseline to 6-months follow-up)

Other Outcomes (4)

• Changes in Weight-related experiential avoidance

  9 months (from Baseline to 6-months follow-up)

• Changes in Self-criticism

  9 months (from Baseline to 6-months follow-up)

• Changes in Self-compassion

  9 months (from Baseline to 6-months follow-up)

Study Arms (2)

Kg-Free

EXPERIMENTAL

Kg-free is a manualized acceptance, mindfulness \& compassionate-based group intervention for women struggling with their weight. It comprises 10 weekly group sessions plus 2 booster fortnightly sessions (31/2months) 2h30 hours each, run in small groups (ranging from 10 to 12 participants).

Behavioral: Kg-Free; Other: Treatment as Usual

Treatment as Usual (TAU)

OTHER

nutritional treatment for weight loss in primary care units and Hospitals from Coimbra's district that includes dietary and physical activity support

Other: Treatment as Usual

Interventions

Kg-Free BEHAVIORAL

Cognitive-behavioral intervention based on promoting acceptance, mindfulness and self-compassion abilities

Kg-Free

Treatment as Usual OTHER

Standard nutritional treatment that involves dietary and physical activity support provided by the medical units Standard

Kg-Free; Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with overweight or obesity (BMI above 25);
• Enrolled in nutritional treatment for weight loss in primary care units and Hospitals from Coimbra

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Coimbra: lead

Related Publications (3)

• Palmeira L, Pinto-Gouveia J, Cunha M. The role of weight self-stigma on the quality of life of women with overweight and obesity: A multi-group comparison between binge eaters and non-binge eaters. Appetite. 2016 Oct 1;105:782-9. doi: 10.1016/j.appet.2016.07.015. Epub 2016 Jul 14.

  PMID: 27423819 BACKGROUND

• Palmeira,L.,Cunha, M.,Pinto-Gouveia, J., Carvalho, S., & Lillis, J. (2016) New developments in the assessment of weight-related experiential avoidance (AAQW-Revised). Journal of Contextual Behavioral Science, in press. http://dx.doi.org/10.1016/j.jcbs.2016.06.001i

  BACKGROUND

• Palmeira L, Pinto-Gouveia J, Cunha M. Exploring the efficacy of an acceptance, mindfulness & compassionate-based group intervention for women struggling with their weight (Kg-Free): A randomized controlled trial. Appetite. 2017 May 1;112:107-116. doi: 10.1016/j.appet.2017.01.027. Epub 2017 Jan 21.

  PMID: 28119138 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• José A. Pinto-Gouveia, PhD

  CINEICC's Coordinator, University of Coimbra

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mcs

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: August 1, 2016
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: August 1, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share