Mindfulness Intervention for Overweight Primary Care Patients

Obesity Clinical Trial

— MindEat  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02893150
• Other study ID #: Mindful Eating
• Status: Completed
• Phase: N/A
• Start date: April 5, 2018
• Est. completion date: December 18, 2019

Study information

• Verified date: October 2021
• Source: Centro Mente Aberta de Mindfulness
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: December 18, 2019
• Est. primary completion date: April 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Brazil	Centro Mente Aberta de Mindfulness e Promoção de Saúde	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Centro Mente Aberta de Mindfulness	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

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* Note: There are 66 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cholesterol and fractions, triglycerides	It is expected reduction in cholesterol and fractions level and triglycerides	Up to 3-month of follow-up
Other	C-reactive protein	It is expected reduction in PCR level	Up to 3-month of follow-up
Other	waist perimeter	It is expected reduction in waist perimeter	Up to 3-month of follow-up
Other	food consumption	It is expected improve quality of food consumption (questionaire)	Up to 3-month of follow-up
Other	Body fat	It is expected to reduce the body fat percentage (bioimpedance)	Up to 3-month of follow-up
Other	Basal metabolism rate	It is expected to increase the basal metabolic rate-calorimeter	Up to 3-month of follow-up
Other	Physical Activity	It is expected to increase the physical activity (Brief Physical Activity Assessment Tool	Up to 3-month of follow-up
Other	Risk of eating Disorder	It is expected to reduce the risk score of eating disorder (questionaire EAT 26)	Up to 3-month of follow-up
Primary	Feeding Behaviour	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	Fasting blood glucose	It is expected the improvement of Fasting blood glucose level	Up to 3-month of follow-up
Secondary	levels of mindfulness,	It expected to increase the levels of Mindfulness-psychometric scale	Up to 3-month of follow-up
Secondary	Levels of depression	It expected to reduce the levels of Depression-psychometric scale	Up to 3-month of follow-up
Secondary	Levels of anxiety	It expected to reduce the levels of anxiety -psychometric scale and serum cortisol	Up to 3-month of follow-up
Secondary	Serum cortisol	It expected to reduce the levels of cortisol	Up to 3-month of follow-up
Secondary	Self-compassion	It expected to improve the levels of self-compassion scale	Up to 3-month of follow-up
Secondary	HBA1C (glycated hemoglobina)	It is expected the improvement of glycated hemoglobina level	Up to 3-month of follow-up
Secondary	Insulin	It is expected reduction in insulin level	Up to 3-month of follow-up