Mindfulness Intervention for Overweight Primary Care Patients

NCT02893150 | Completed

• 1 other identifier: Mindful Eating
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Keywords

Mindful Eating; Overweight; Primary Care; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Fasting blood glucose

  Up to 3-month of follow-up

• levels of mindfulness,

  Up to 3-month of follow-up

• Levels of depression

  Up to 3-month of follow-up

• Levels of anxiety

  Up to 3-month of follow-up

• Serum cortisol

  Up to 3-month of follow-up

Other Outcomes (8)

• Cholesterol and fractions, triglycerides

  Up to 3-month of follow-up

• C-reactive protein

  Up to 3-month of follow-up

• waist perimeter

  Up to 3-month of follow-up

Study Arms (3)

TAU (treatment as usual)

ACTIVE COMPARATOR

The Treatment as Usual (TAU) will be considered as following: 1) In the cases of individuals presenting overweight (BMI of 25 kg/m ² to 29.9 kg/m ²), but without comorbidities, primary care teams propose the improvement of the life style (more physically active, and with a better eating behaviour) in order to return to the track of normal BMI (BMI of 18.5 kg/m ² to 24.9 kg/m ²). 2) For those who have comorbidities such as hypertension and diabetes, in addition to including individuals in group activities (psycho-education), it is evaluated the need for individual dietary prescription by a nutritionist.

Behavioral: TAU

TAU+MBHP

ACTIVE COMPARATOR

The Mindfulness-based Health Promotion (MBHP) developed by our research group (generic protocol) will be adapted from the Mindfulness-based Stress Reduction program (MBSR), 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.

Behavioral: TAU+MBHP

TAU+MB-EAT

EXPERIMENTAL

The Mindfulness-based Eating Awareness (MB-EAT) protocol consists in ten weekly sessions of 2,5 hour to improve compulsive eating, and to promote conscious eating.

Behavioral: TAU+MB-EAT

Interventions

TAU BEHAVIORAL

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)

TAU+MBHP BEHAVIORAL

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+MBHP

TAU+MB-EAT BEHAVIORAL

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

TAU+MB-EAT

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Mente Aberta de Mindfulness: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Centro Mente Aberta de Mindfulness e Promoção de Saúde

São Paulo, São Paulo, Brazil

Location

Related Publications (68)

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  RESULT

• Salvo V, Schveitzer MC, Sanudo A, Favarato ML, Demarzo M. Exploring perceptions about Mindfulness and Mindful Eating Programs for low-income women with overweight in primary health care. Nutr Health. 2023 Jun;29(2):319-329. doi: 10.1177/02601060221075537. Epub 2022 Feb 9.

  PMID: 35138182 DERIVED

• Salvo V, Kristeller J, Montero Marin J, Sanudo A, Lourenco BH, Schveitzer MC, D'Almeida V, Morillo H, Gimeno SGA, Garcia-Campayo J, Demarzo M. Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial. Trials. 2018 May 11;19(1):277. doi: 10.1186/s13063-018-2639-y.

  PMID: 29751819 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcelo Demarzo, MD, PhD

  UNIFESP - Federal University of Sao Paulo, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Phd.

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 8, 2016
• Study Start: April 5, 2018
• Primary Completion: April 5, 2018
• Study Completion: December 18, 2019
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

BR (1)