Clinical trial NCT03718728: Effect of a Group Intervention Program Based on Acceptance and Mindfulness on the Physical and Emotional Well-being of Overweight and Obese Individuals
Official title: The Effect of a Group Intervention Program Based on Acceptance and Mindfulness on the Physical and Emotional Well-being of Overweight and Obese Individuals; Mind&Life Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Overweight
Obesity
Adults
Mindfulness
Acceptance
Emotional eating
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
name: Basque Health Service
First posted: 2018-10-24
Enrollment: 142
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the present study is to evaluate the effect of a 20-week group intervention program based on acceptance and mindfulness in emotional eating, weight loss, physiological parameters and the level of physical exercise, as well as in the quality-of-life and weight self-stigma of overweight and obese people on the short- and medium-term.

Design, participants, and method: A randomized clinical trial comprising a total of 110 overweight or obese (BMI ≥ 25) participants that are receiving medical treatment at Primary Care Centers, 20-65 years, will be included and randomly assigned to standard program (N=55) or standard + intervention program (N=55). The standard program group will receive the treatment as usual (TAU) that comprises 5 sessions (on a monthly basis) that will include a personalized diet and physical exercise recommendations, while the standard + intervention program group will receive the same TAU plus the acceptance and mindfulness-based group intervention program.

At baseline prior to randomization, after the intervention, and seven months after the program has finished anthropometric and body composition data, biochemical data in blood, waist circumference, blood pressure, eating habits, level of physical exercise, general health, emotional eating, quality-of-life, weight self-stigma, experiential avoidance, self-compassion level and mindfulness abilities will be evaluated.

It is hypothesized that the integrated treatment of obesity implementing a group intervention program based on acceptance and mindfulness could help to reduce the emotional eating, enhance weight loss, improve physiological parameters, increase the level of physical exercise, improve the quality of life and reduce the weight self-stigma of overweight and obese individuals.

Detailed description: The standard program group will receive the TAU that comprises 5 monthly sessions of 30 minutes that will include a personalized diet and physical exercise recommendations.

The standard + intervention program group will receive the same TAU plus the acceptance and mindfulness-based group intervention program. The first ten sessions will be held weekly and the last five, biweekly. The duration of sessions will be 2 hours and will include a mindfulness practice, the session content (i.e. control as the problem, willingness, etc.), followed by a mindful eating practice to train the ability to pay attention to food and eating physical sensations. Finally, the session content will be briefly revised and practices for the week will be established.

The following measurements will be evaluated at baseline prior to randomization, after the intervention, and seven months after the program has finished: anthropometric and body composition data, that is, weight and fat and muscle mass percentage (Bio-electrical Impedance Analysis, TANITA) and height (SECA 227); biochemical data in blood; waist circumference (Holtain inelastic tape); blood pressure; eating habits (24h recall and PREDIMED); level of physical exercise (IPAQ); general health (GHQ-28); emotional eating (DEBQ); quality-of-life (IWQOL-Lite); weight self-stigma (WSSQ); experiential avoidance (AAQ-II); self-compassion level (SCS) and mindfulness abilities (FFMQ).

Eligibility criteria: Inclusion Criteria:

* Adults with overweight or obesity (estimated by BMI ≥ 25 and classified by the International Obesity Task Force, IOTF);
* Have asked for enrollment in nutritional treatment for weight loss in primary care units from Donostia-San Sebastian;
* Willingness to participate in the study.

Exclusion Criteria:

* Diagnosed with eating disorders; such as, Binge Eating Disorder, Anorexia or Bulimia;
* Diagnosed with any psychiatric disorder or intellectual disability that doesn't allow to carry out the intervention;
* Not to know sufficiently the language the intervention is carried out.

Primary outcomes:
measure: Changes in Body Mass Index (BMI) measured by Bio-electrical Impedance Analysis (TANITA)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in eating habits estimated by 24h recall and PREDIMED questionnaire
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in the level of physical exercise estimated by the International Physical Activity Questionnaire (IPAQ)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in emotional eating estimated by the Dutch Eating Behaviour Questionnaire (DEBQ)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in the quality of life estimated by the Impact of Weight in the Quality of Life-Lite Questionnaire (IWQOL-Lite)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in weight self-stigma estimated by the Weight Self-Stigma Questionnaire (WSSQ)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Secondary outcomes:
measure: Changes in fat percentage measured by Bio-electrical Impedance Analysis (TANITA)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in muscle mass percentage measured by Bio-electrical Impedance Analysis (TANITA)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in insulin sensitivity measured by homeostasis model assessment (HOMA)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in serum lipid profile
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in glucose profile measured by a spectrophotometry
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in waist circumference measured by an inelastic tape (Holtain)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in blood pressure measured by a sphygmomanometer
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in general health estimated by the General Health Questionnaire-28 (GHQ-28)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in eating attitudes estimated by the Eating Attitudes Test-12 (EAT-12)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in body image's self-perception estimated by the Figure Rating Scale (FRS)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Other outcomes:
measure: Changes in experiential avoidance estimated by the Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in self-compassion level estimated by the Self-Compassion Scale (SCS)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in mindfulness abilities measured by the Five Facets Mindfulness Questionnaire (FFMQ)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in avoidance and inflexibility in relation to difficult weight-related thoughts and feelings estimated by the Acceptance and Action Questionnaire for Weight-Related Problems (AAQ-W)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in body image flexibility estimated by the Body Image-Acceptance and Action Questionnaire (BI-AAQ)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in the fit between participant's actual activities and the valued behavioral pattern measured by Valued Living Questionnaire (VLQ)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
measure: Changes in cognitive fusion measured by the Cognitive Fusion Questionnaire (CFQ)
timeFrame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Locations:
city: Donostia-San Sebastian
country: Spain
facility: Department of Personality Assesment and Psychological Treatments of the Faculty of Psychology of the Basque Country University (UPV/EHU)
state: Gipuzkoa
Study officials:
affiliation: Assistant teacher in the Department of Personality, Assessment and Psychological Treatments of the Faculty of Psychology of the Basque Country University (EHU/UPV)
name: Edurne Maiz Aldalur, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor in Clinical Psychology in the Department of Personality, Assessment and Psychological Treatments of the Faculty of Psychology of the Basque Country University (EHU/UPV)
name: Enrique Echeburúa Odriozola, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iturbe I, Pereda-Pereda E, Echeburua E, Maiz E. The Effectiveness of an Acceptance and Commitment Therapy and Mindfulness Group Intervention for Enhancing the Psychological and Physical Well-Being of Adults with Overweight or Obesity Seeking Treatment: The Mind&Life Randomized Control Trial Study Protocol. Int J Environ Res Public Health. 2021 Apr 21;18(9):4396. doi: 10.3390/ijerph18094396.