Mindfulness Intervention for Overweight Primary Care Patients (MindEat)

October 7, 2021 updated by: Marcelo Demarzo, MD, PhD, Centro Mente Aberta de Mindfulness

Mindfulness as a Complementary Intervention for Overweight Primary Care Patients: Study Protocol for a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

284

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil
        • Centro Mente Aberta de Mindfulness e Promoção de Saúde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TAU (treatment as usual)
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.
Behavioral: TAU

TAU (Treatment as Usual), individuals presenting with overweight (BMI of 25 kg/m ² to 29.9 kg/m ²), but without comorbidities, teams of primary care (PC) organized care plans to return to the track of normal BMI (BMI of 18.5 kg/m ² to 24.9 kg/m ²).

For those who have comorbidities such as hypertension and diabetes, in addition to including individuals in group activities, evaluates the need for individual dietary prescription by the nutritionist. This decision is discussed among the team of PC and Matrix support team
Active Comparator: TAU+MBHP
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.
Behavioral: TAU+MBHP
TAU (Treatment as Usual) + MBHP. We used a general (general vulnerability, not specific) mindfulness-based intervention (MBI) developed by our research group, an 8-week-group-based MBI called "Mindfulness-Based Health Promotion" (MBHP) program . 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; more feasible to be implement in health services and facilities
Experimental: TAU+MB-EAT
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.
Behavioral: TAU+MB-EAT
TAU (Treatment as Usual) + MB-EAT (mindfulness-based eating awareness training). Adapted from the MBSR, Mindfulness-based Eating Awareness Training (MB-EAT) or awareness training. This program was specially developed for the compulsive eating disorders and related problems[47]. In addition the four main techniques of meditation mentioned in the MBHP program includes modifications to these basic techniques, and include experimentation with different flavors, sweet and savory foods, etc. Has 10 weekly sessions of 2,5h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeding Behaviour
Time Frame: Up to 3-month of follow-up
It is expected the improvement of the feeding behaviour measured by Dutch Eating Behaviour Questionaire (DEBQ) in total score and in 3 subscales: Restriction , External Intake and Emotional Intake and with the scale EAT 26
Up to 3-month of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting blood glucose
Time Frame: Up to 3-month of follow-up
It is expected the improvement of Fasting blood glucose level
Up to 3-month of follow-up
levels of mindfulness,
Time Frame: Up to 3-month of follow-up
It expected to increase the levels of Mindfulness-psychometric scale
Up to 3-month of follow-up
Levels of depression
Time Frame: Up to 3-month of follow-up
It expected to reduce the levels of Depression-psychometric scale
Up to 3-month of follow-up
Levels of anxiety
Time Frame: Up to 3-month of follow-up
It expected to reduce the levels of anxiety -psychometric scale and serum cortisol
Up to 3-month of follow-up
Serum cortisol
Time Frame: Up to 3-month of follow-up
It expected to reduce the levels of cortisol
Up to 3-month of follow-up
Self-compassion
Time Frame: Up to 3-month of follow-up
It expected to improve the levels of self-compassion scale
Up to 3-month of follow-up
HBA1C (glycated hemoglobina)
Time Frame: Up to 3-month of follow-up
It is expected the improvement of glycated hemoglobina level
Up to 3-month of follow-up
Insulin
Time Frame: Up to 3-month of follow-up
It is expected reduction in insulin level
Up to 3-month of follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cholesterol and fractions, triglycerides
Time Frame: Up to 3-month of follow-up
It is expected reduction in cholesterol and fractions level and triglycerides
Up to 3-month of follow-up
C-reactive protein
Time Frame: Up to 3-month of follow-up
It is expected reduction in PCR level
Up to 3-month of follow-up
waist perimeter
Time Frame: Up to 3-month of follow-up
It is expected reduction in waist perimeter
Up to 3-month of follow-up
food consumption
Time Frame: Up to 3-month of follow-up
It is expected improve quality of food consumption (questionaire)
Up to 3-month of follow-up
Body fat
Time Frame: Up to 3-month of follow-up
It is expected to reduce the body fat percentage (bioimpedance)
Up to 3-month of follow-up
Basal metabolism rate
Time Frame: Up to 3-month of follow-up
It is expected to increase the basal metabolic rate-calorimeter
Up to 3-month of follow-up
Physical Activity
Time Frame: Up to 3-month of follow-up
It is expected to increase the physical activity (Brief Physical Activity Assessment Tool
Up to 3-month of follow-up
Risk of eating Disorder
Time Frame: Up to 3-month of follow-up
It is expected to reduce the risk score of eating disorder (questionaire EAT 26)
Up to 3-month of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Mente Aberta de Mindfulness

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Marcelo Demarzo, MD, PhD, UNIFESP - Federal University of Sao Paulo, Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2018

Primary Completion (Actual)

April 5, 2018

Study Completion (Actual)

December 18, 2019

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 7, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mindful Eating

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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