Mindfulness Intervention for Overweight Primary Care Patients
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

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).
    

Intervention name(s): TAU; TAU+MBHP; TAU+MB-EAT
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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 (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 (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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Mindful Eating; Overweight; Primary Care; Randomized Clinical Trial