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)

University of the Basque Country (UPV/EHU)

Status: Completed

Conditions: Overweight and Obesity

Treatments: Behavioral: Mind&Life; Behavioral: Standard

Study type: Interventional

Funder types: Other

Identifiers

NCT03718728

PSI2017-88583-R

Details and patient eligibility

About

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.

Full 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).

Enrollment: 142 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Standard group

Active Comparator group

Description:

A personalized diet and physical exercise recommendations.

Treatment:

Behavioral: Standard

Mind&Life (standard + intervention) group

Experimental group

Description:

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

Treatment:

Behavioral: Standard

Behavioral: Mind&Life