NCT03718728: Mind&Life

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

Completed NA Last updated 9 February 2023

What this trial tests

NA trial testing Mind&Life in Overweight and Obesity in 142 participants. Completed in 1 October 2022.

Timeline

3 November 2018

Primary endpoint
1 October 2022

1 October 2022

Quick facts

Lead sponsor	University of the Basque Country (UPV/EHU)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	142
Start date	3 November 2018
Primary completion	1 October 2022
Estimated completion	1 October 2022
Sites	1 location across Spain

Drugs / interventions tested

• Mind&Life
• Standard

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →

Sponsor

University of the Basque Country (UPV/EHU)

Who can join

Adults 20 to 70, any sex, with Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.