Mindfulness Intervention for Overweight Primary Care Patients

Not Applicable

Completed

• Conditions: Overweight; Obesity

• Registration Number: NCT02893150
• Lead Sponsor: Centro Mente Aberta de Mindfulness

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).

Study Timeline

• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-08
• Study Start: 2018-04-05
• Primary Completion: 2018-04-05
• Study Completion: 2019-12-18
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 284

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Fasting blood glucose	Up to 3-month of follow-up	It is expected the improvement of Fasting blood glucose level
Serum cortisol	Up to 3-month of follow-up	It expected to reduce the levels of cortisol
levels of mindfulness,	Up to 3-month of follow-up	It expected to increase the levels of Mindfulness-psychometric scale
Self-compassion	Up to 3-month of follow-up	It expected to improve the levels of self-compassion scale
Levels of depression	Up to 3-month of follow-up	It expected to reduce the levels of Depression-psychometric scale
Insulin	Up to 3-month of follow-up	It is expected reduction in insulin level
Levels of anxiety	Up to 3-month of follow-up	It expected to reduce the levels of anxiety -psychometric scale and serum cortisol
HBA1C (glycated hemoglobina)	Up to 3-month of follow-up	It is expected the improvement of glycated hemoglobina level

Trial Locations

Locations (1)

Centro Mente Aberta de Mindfulness e Promoção de Saúde; 🇧🇷 São Paulo, SP, Brazil