CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 284 enrolled
Drug / intervention
TAU +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02893150
NCT02893150N/ACompleted

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

Centro Mente Aberta de Mindfulness·interventional·Posted Sep 8, 2016·Updated Oct 15, 2021

In Brief

A clinical study evaluating TAU, TAU+MBHP, and 1 other intervention for Overweight and Obesity. Completed, enrolled 284 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight, Obesity
CountriesBrazil

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 8, 2016
Enrollment StartApr 5, 2018
Primary CompletionApr 5, 2018
Study CompletionDec 18, 2019
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 9.8 years ago

Interventions

TAUbehavioral

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+MBHPbehavioral

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-EATbehavioral

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