Mindfulness Intervention for Overweight Primary Care Patients (MindEat)

Centro Mente Aberta de Mindfulness

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: TAU; Behavioral: TAU+MB-EAT; Behavioral: TAU+MBHP

Study type: Interventional

Funder types: Other

Identifiers

NCT02893150

Mindful Eating

Details and patient eligibility

About

Mindfulness has been applied in the United States and Europe to improve both physical and psychological health, however, it is still poorly studied in Brazil. Mindfulness, or its lack, may also have particular relevance to obesity and eating disorders, reducing the episodes of "binge eating", which are partly responsible for weight regain for many people, and improving the eating behavior in order to promote awareness of emotional states which distort the physiological signals generated by the process. The hypothesis is that Mindfulness-based Interventions (MBI) as well as specific programmes focused on conscious eating, as Mindfulness Based Eating Awareness Training (MB-EAT) can, in short time, and in a sustainable fashion, improve biochemical, psychometric and anthropometric parameters in primary care patients with overweight.

Full description

A randomized-controlled trial will be conducted to compare treatment-as-usual (TAU) in Primary Care combined a generic MBI (with 8 sessions) developed by our research group, called "Mindfulness-Based Health Promotion" (MBHP) program versus TAU plus MB-EAT. It will be included women aged ≥18 and < 60, literate , with a BMI (body mass index) ≥ 25 kg/m2. The primary outcome is the improvement of the eating behaviour measured by DEBQ. Secondary outcomes are: It is expected improvement of nutritional status (reduction of body weight by at least 5% of the weight) along the intervention, as well as maintenance of this (without weight regain) which could lead to the prevention of multiple morbidities related to excess body weight. Will be assessed the levels of Mindfulness, stress, anxiety (psychometric scale and serum cortisol) and self-compassion. There will be performed basal (baseline), at post-intervention, 3 and 6 months follow-up measurements. The control group will receive the intervention that has been shown to be more effective at the end of the study (MBHP or MB-EAT).

Enrollment: 284 patients

Sex: Female

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• women aged 18-59 years old, literate;
• Primary Care patients who have the body mass index (BMI) ≥25kgm2 and < 40kg/m2
• People who have an interest in the objectives of this study and consented to be randomized to one of three arms.
• Those who have participated in 75% of sessions or only two absences in the program

Exclusion criteria

• those who are under pharmacological treatment for overweight;
• pregnant women;
• those who have problems with substance use (drugs and alcohol);
• untreated hypothyroidism or hyperthyroidism;
• those who are in acute phase of depression (less than 6 months in depression); schizophrenia or psychotic disorders or who are using drugs that cause cognitive attentional and concentration losses (such as powerful anti-anxiety drugs);
• current practitioners of Mindfulness, meditation, yoga, or the like, in the last 6 months (with formal practice at least once a week);
• those who have undergone any type of Bariatric Surgery.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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284 participants in 3 patient groups

TAU (treatment as usual)

Active Comparator group

Description:

The Treatment as Usual (TAU) will be considered as following: 1) In the cases of individuals presenting overweight (BMI of 25 kg/m ² to 29.9 kg/m ²), but without comorbidities, primary care teams propose the improvement of the life style (more physically active, and with a better eating behaviour) in order to return to the track of normal BMI (BMI of 18.5 kg/m ² to 24.9 kg/m ²). 2) For those who have comorbidities such as hypertension and diabetes, in addition to including individuals in group activities (psycho-education), it is evaluated the need for individual dietary prescription by a nutritionist.

Treatment:

Behavioral: TAU

TAU+MBHP

Active Comparator group

Description:

The Mindfulness-based Health Promotion (MBHP) developed by our research group (generic protocol) will be adapted from the Mindfulness-based Stress Reduction program (MBSR), It is based on the original model developed by Jon Kabat-Zinn and colleagues (MBSR), and subsequently adapted by our research group in order to fit it better into the context and needs of Primary Care (PC) and national and local Health Systems\], which has been applied by the Center "Mente Aberta" in Brazil (www.mindfulnessbrasil.com), and by the University of Zaragoza, in Spain (www.webmindfulness.com). One of the sessions (the sixth one) is developed in silence, with the goal of deepening the mindfulness practice.

Treatment:

Behavioral: TAU+MBHP

TAU+MB-EAT

Experimental group

Description:

The Mindfulness-based Eating Awareness (MB-EAT) protocol consists in ten weekly sessions of 2,5 hour to improve compulsive eating, and to promote conscious eating.

Treatment:

Behavioral: TAU+MB-EAT