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

NCT03718728 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2023-02-09

No results posted yet for this study

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

Interventions

BEHAVIORAL

Mind&Life

Acceptance and mindfulness-based group intervention program.

BEHAVIORAL

Standard

Personalized diet and physical exercise recommendations.

Sponsors & Collaborators

  • Ministerio de Economía y Competitividad, Spain

    collaborator OTHER_GOV
  • Basque Health Service

    collaborator OTHER_GOV
  • University of the Basque Country (UPV/EHU)

    lead OTHER

Principal Investigators

  • 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)

  • 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)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-03
Primary Completion
2022-10-01
Completion
2022-10-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03718728 on ClinicalTrials.gov