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Completed

NCT Number: NCT02893150

Mindfulness Intervention for Overweight Primary Care Patients

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centro Mente Aberta de Mindfulness e Promoção de Saúde

São Paulo, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TAU

Behavioral

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

TAU+MBHP

Behavioral

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

TAU+MB-EAT

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Fasting blood glucose

    Time frame: Up to 3-month of follow-up

    It is expected the improvement of Fasting blood glucose level

  2. levels of mindfulness,

    Time frame: Up to 3-month of follow-up

    It expected to increase the levels of Mindfulness-psychometric scale

  3. Levels of depression

    Time frame: Up to 3-month of follow-up

    It expected to reduce the levels of Depression-psychometric scale

  4. 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

  5. Serum cortisol

    Time frame: Up to 3-month of follow-up

    It expected to reduce the levels of cortisol

  6. Self-compassion

    Time frame: Up to 3-month of follow-up

    It expected to improve the levels of self-compassion scale

  7. HBA1C (glycated hemoglobina)

    Time frame: Up to 3-month of follow-up

    It is expected the improvement of glycated hemoglobina level

  8. Insulin

    Time frame: Up to 3-month of follow-up

    It is expected reduction in insulin level

Other outcomes

  1. Cholesterol and fractions, triglycerides

    Time frame: Up to 3-month of follow-up

    It is expected reduction in cholesterol and fractions level and triglycerides

  2. C-reactive protein

    Time frame: Up to 3-month of follow-up

    It is expected reduction in PCR level

  3. waist perimeter

    Time frame: Up to 3-month of follow-up

    It is expected reduction in waist perimeter

  4. food consumption

    Time frame: Up to 3-month of follow-up

    It is expected improve quality of food consumption (questionaire)

  5. Body fat

    Time frame: Up to 3-month of follow-up

    It is expected to reduce the body fat percentage (bioimpedance)

  6. Basal metabolism rate

    Time frame: Up to 3-month of follow-up

    It is expected to increase the basal metabolic rate-calorimeter

  7. Physical Activity

    Time frame: Up to 3-month of follow-up

    It is expected to increase the physical activity (Brief Physical Activity Assessment Tool

  8. 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)

Sponsors and collaborators

Lead sponsor

Centro Mente Aberta de Mindfulness

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

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

Acronym: MindEat

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 8, 2016
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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