Effect of a Group Intervention Program Based on Acceptance and Mindfulness on the Physical and Emotional Well-being of Overweight and Obese Individuals

NCT03718728 | Completed

• 1 other identifier: PSI2017-88583-R
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Overweight; Obesity; Adults; Mindfulness; Acceptance; Emotional eating

Outcome Measures

Primary Outcomes (6)

• Changes in Body Mass Index (BMI) measured by Bio-electrical Impedance Analysis (TANITA)

  Changes in Body Mass Index (BMI - kg/m2) will be measured by Bio-electrical Impedance Analysis (TANITA).

  Pretreatment-Posttreatment (5 months)-7 months follow-up

• Changes in eating habits estimated by 24h recall and PREDIMED questionnaire

  Changes in eating habits will be estimated by 24h recall and PREDIMED questionnaire which is a questionnaire to assess the adherence to the Mediterranean diet, 0 being the minimum total score and 14 the maximum total score. Higher values represent a higher adherence to the Mediterranean diet.

  Pretreatment-Posttreatment (5 months)-7 months follow-up

• Changes in the level of physical exercise estimated by the International Physical Activity Questionnaire (IPAQ)

  Changes in the level of physical exercise will be estimated by the International Physical Activity Questionnaire (IPAQ) which is a questionnaire to assess the level of physical activity. This questionnaire obtains the subject's Metabolic Equivalent of Task (MET) of the last week adding up the MET values of the different types of physical activities the subject has done in the last week. Higher values represent a higher level of physical activity.

  Pretreatment-Posttreatment (5 months)-7 months follow-up

• Changes in emotional eating estimated by the Dutch Eating Behaviour Questionnaire (DEBQ)

  Changes in emotional eating will be estimated by the Dutch Eating Behaviour Questionnaire (DEBQ) which is a questionnaire that comprises three scales that measure emotional, external and restrained eating; being 0 the minimum score and 52 the maximum score of the emotional eating scale, 0 the minimum score and 40 the maximum score of the external eating scale and 0 the minimum score and 40 the maximum score of the restrained eating scale. Higher values represent a higher emotional, external or restrained eating.

  Pretreatment-Posttreatment (5 months)-7 months follow-up

• Changes in the quality of life estimated by the Impact of Weight in the Quality of Life-Lite Questionnaire (IWQOL-Lite)

  Changes in the quality of life will be estimated by the Impact of Weight in the Quality of Life-Lite Questionnaire (IWQOL-Lite) which is a questionnaire to assess quality of life in obesity. It comprises five subscales that measure weight-related concerns across five domains: Physical Function, Self-Esteem, Sexual Life, Public Distress and Work. The minimum score of the total punctuation is 31 and the maximum punctuation is 155; the minimum score of the Physical Function scale is 11 and the maximum score is 55; the minimum score of the Self-Esteem scale is 7 and the maximum score is 35; the minimum score of the Sexual Life scale is 4 and the maximum score is 20; the minimum score of the Public Distress scale is 5 and the maximum score is 25 and the minimum score of the Work scale is 4 and the maximum is 20. Higher values represent a higher impact of weight in the quality of life of the individual, in the total score and in each of the domains assessed.

  Pretreatment-Posttreatment (5 months)-7 months follow-up

• Changes in weight self-stigma estimated by the Weight Self-Stigma Questionnaire (WSSQ)

  Changes in weight self-stigma will be estimated by the Weight Self-Stigma Questionnaire (WSSQ) which is a questionnaire to assess weight-related self-stigma that comprises two subscales apart from the total punctuation: self-devaluation and fear of enacted stigma. The minimum score of the total punctuation is 0 and the maximum is 72; the minimum score of the Self-Devaluation subscale is 0 and the maximum is 36; the minimum score of the Fear of Enacted-Stigma subscale is 0 and the maximum is 36. Higher values represent a higher weight-related self-stigma, in the total score and in each of the subscales.

  Pretreatment-Posttreatment (5 months)-7 months follow-up

Secondary Outcomes (10)

• Changes in fat percentage measured by Bio-electrical Impedance Analysis (TANITA)

  Pretreatment-Posttreatment (5 months)-7 months follow-up

• Changes in muscle mass percentage measured by Bio-electrical Impedance Analysis (TANITA)

  Pretreatment-Posttreatment (5 months)-7 months follow-up

• Changes in insulin sensitivity measured by homeostasis model assessment (HOMA)

  Pretreatment-Posttreatment (5 months)-7 months follow-up

• Changes in serum lipid profile

  Pretreatment-Posttreatment (5 months)-7 months follow-up

• Changes in glucose profile measured by a spectrophotometry

  Pretreatment-Posttreatment (5 months)-7 months follow-up

Other Outcomes (7)

• Changes in experiential avoidance estimated by the Acceptance and Action Questionnaire-II (AAQ-II)

  Pretreatment-Posttreatment (5 months)-7 months follow-up

• Changes in self-compassion level estimated by the Self-Compassion Scale (SCS)

  Pretreatment-Posttreatment (5 months)-7 months follow-up

• Changes in mindfulness abilities measured by the Five Facets Mindfulness Questionnaire (FFMQ)

  Pretreatment-Posttreatment (5 months)-7 months follow-up

Study Arms (2)

Standard group

ACTIVE COMPARATOR

A personalized diet and physical exercise recommendations.

Behavioral: Standard

Mind&Life (standard + intervention) group

EXPERIMENTAL

A personalized diet and physical exercise recommendations plus the acceptance and mindfulness-based group intervention program.

Behavioral: Mind&Life; Behavioral: Standard

Interventions

Mind&Life BEHAVIORAL

Acceptance and mindfulness-based group intervention program.

Mind&Life (standard + intervention) group

Standard BEHAVIORAL

Personalized diet and physical exercise recommendations.

Mind&Life (standard + intervention) group; Standard group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead
• Ministerio de Economía y Competitividad, Spain: collaborator
• Basque Health Service: collaborator

Study Sites (1)

Department of Personality Assesment and Psychological Treatments of the Faculty of Psychology of the Basque Country University (UPV/EHU)

Donostia / San Sebastian, Gipuzkoa, 20018, Spain

Location

Related Publications (1)

• 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.

  PMID: 33919059 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Emotional Eating

Condition Hierarchy (Ancestors)

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

Study Officials

• Edurne Maiz Aldalur, PhD

  Assistant teacher in the Department of Personality, Assessment and Psychological Treatments of the Faculty of Psychology of the Basque Country University (EHU/UPV)

  PRINCIPAL INVESTIGATOR

• Enrique Echeburúa Odriozola, Professor

  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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Lecturer of School Psychology

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 24, 2018
• Study Start: November 3, 2018
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)