Obesity, Overweight
Conditions
Keywords
Mindful Eating, Overweight, Primary Care, Randomized Clinical Trial
Brief summary
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.
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).
Interventions
BEHAVIORALTAU
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
BEHAVIORALTAU+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
BEHAVIORALTAU+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
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Centro Mente Aberta de Mindfulness
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 59 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feeding Behaviour | 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
| Measure | Time frame | Description |
|---|---|---|
| Fasting blood glucose | Up to 3-month of follow-up | It is expected the improvement of Fasting blood glucose level |
| levels of mindfulness, | Up to 3-month of follow-up | It expected to increase the levels of Mindfulness-psychometric scale |
| Levels of depression | Up to 3-month of follow-up | It expected to reduce the levels of Depression-psychometric scale |
| Levels of anxiety | Up to 3-month of follow-up | It expected to reduce the levels of anxiety -psychometric scale and serum cortisol |
| Serum cortisol | Up to 3-month of follow-up | It expected to reduce the levels of cortisol |
| Self-compassion | Up to 3-month of follow-up | It expected to improve the levels of self-compassion scale |
| HBA1C (glycated hemoglobina) | Up to 3-month of follow-up | It is expected the improvement of glycated hemoglobina level |
| Insulin | Up to 3-month of follow-up | It is expected reduction in insulin level |
Other
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein | Up to 3-month of follow-up | It is expected reduction in PCR level |
| waist perimeter | Up to 3-month of follow-up | It is expected reduction in waist perimeter |
| food consumption | Up to 3-month of follow-up | It is expected improve quality of food consumption (questionaire) |
| Body fat | Up to 3-month of follow-up | It is expected to reduce the body fat percentage (bioimpedance) |
| Basal metabolism rate | Up to 3-month of follow-up | It is expected to increase the basal metabolic rate-calorimeter |
| Physical Activity | Up to 3-month of follow-up | It is expected to increase the physical activity (Brief Physical Activity Assessment Tool |
| Risk of eating Disorder | Up to 3-month of follow-up | It is expected to reduce the risk score of eating disorder (questionaire EAT 26) |
| Cholesterol and fractions, triglycerides | Up to 3-month of follow-up | It is expected reduction in cholesterol and fractions level and triglycerides |
Countries
Brazil
Outcome results
None listed