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OverweightMindEatNCT02893150

Mindfulness Intervention for Overweight Primary Care Patients

A study testing TAU, TAU+MBHP and TAU+MB-EAT in people with Overweight and Obesity, run by Centro Mente Aberta de Mindfulness at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 59 years, women onlyHealthy volunteers can take part
Conditions the study is for
Overweight, Obesity
What is being tested?
TAU, TAU+MBHP and TAU+MB-EAT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
284 participants
Where
1 siteBrazil
Study dates
5 Apr 2018to 18 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Centro Mente Aberta de Mindfulness e Promoção de Saúde

    São Paulo, São Paulo

Other trials in Brazil

About this study

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

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.

Read the 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).

Conditions
Overweight, Obesity
Being tested
TAU, TAU+MBHP, TAU+MB-EAT
Keywords
Mindful Eating, Overweight, Primary Care, Randomized Clinical Trial
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAUBehavioural

    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+MBHPBehavioural

    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-EATBehavioural

    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

Study groups in NCT02893150
Study groupRoleWhat they receive
TAU (treatment as usual)Active comparatorThe 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.
Receives: Behavioral: TAU
TAU+MBHPActive comparatorThe 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.
Receives: Behavioral: TAU+MBHP
TAU+MB-EATExperimentalThe 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.
Receives: Behavioral: TAU+MB-EAT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 3-month of follow-up

Secondary outcomes (8)

  1. Fasting blood glucose

    It is expected the improvement of Fasting blood glucose level

    Measured: Up to 3-month of follow-up

  2. levels of mindfulness,

    It expected to increase the levels of Mindfulness-psychometric scale

    Measured: Up to 3-month of follow-up

  3. Levels of depression

    It expected to reduce the levels of Depression-psychometric scale

    Measured: Up to 3-month of follow-up

  4. Levels of anxiety

    It expected to reduce the levels of anxiety -psychometric scale and serum cortisol

    Measured: Up to 3-month of follow-up

  5. Serum cortisol

    It expected to reduce the levels of cortisol

    Measured: Up to 3-month of follow-up

  6. Self-compassion

    It expected to improve the levels of self-compassion scale

    Measured: Up to 3-month of follow-up

  7. HBA1C (glycated hemoglobina)

    It is expected the improvement of glycated hemoglobina level

    Measured: Up to 3-month of follow-up

  8. Insulin

    It is expected reduction in insulin level

    Measured: Up to 3-month of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2016 (estimated)
  2. Study start5 Apr 2018
  3. Primary completion5 Apr 2018
  4. Study completion18 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
284 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02893150
Sponsor's protocol ID
Mindful Eating
Acronym
MindEat
Status last verified
Oct 2021
First submitted
29 Aug 2016
Last updated
15 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Brasil. Ministério da Saúde. Secretaria de Atenção à Saúde. Departamento de Atenção Básica. Estratégias para o cuidado da pessoa com doença crônica : obesidade / Ministério da Saúde, Secretaria de Atenção à Saúde, Departamento de Atenção Básica. - Brasília : Ministério da Saúde, 2014. 212 p. : il. - (Cadernos de Atenção Básica, n. 38)- Academy of Nutrition and Dietetics. Weight Management Matters, 7 (4), Spring; 2010

  • IBGE. Pesquisa de Orçamentos Familiares 2008-2009: análise do consumo alimentar pessoal no Brasil. Rio de Janeiro: Instituto Brasileiro de Geografia e Estatística, 2011

  • Moura EC, Silva SA, Malta DC, Morais Neto OL. [Risk and protective factors for chronic non-communicable diseases: the VIGITEL telephone disease surveillance system, Brazil, 2007]. Cad Saude Publica. 2011 Mar;27(3):486-96. doi: 10.1590/s0102-311x2011000300009. Portuguese.

    PubMed 21519699

  • ______. Pesquisa de Orçamentos Familiares 2008-2009: análise do consumo alimentar pessoal no Brasil. Rio de Janeiro: Instituto Brasileiro de Geografia e Estatística, 2011.

  • Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38.

    PubMed 10170434

  • Glanz K. Review of nutritional attitudes and counseling practices of primary care physicians. Am J Clin Nutr. 1997 Jun;65(6 Suppl):2016S-2019S. doi: 10.1093/ajcn/65.6.2016S.

    PubMed 9174514

  • De Nooijer J, Van Assema P, De Vet E, Brug J. How stable are stages of change for nutrition behaviors in the Netherlands? Health Promot Int. 2005 Mar;20(1):27-32. doi: 10.1093/heapro/dah504. Epub 2005 Jan 24.

    PubMed 15668216

  • Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.

    PubMed 11234459

  • Byrne S, Cooper Z, Fairburn C. Weight maintenance and relapse in obesity: a qualitative study. Int J Obes Relat Metab Disord. 2003 Aug;27(8):955-62. doi: 10.1038/sj.ijo.0802305.

    PubMed 12861237

  • Gusmão, J. L. et al. Adesão ao tratamento em hipertensão arterial sistólica isolada. Revista Brasileira de Hipertensão. 2009. 16(1): p. 38-43.

  • Santos, A. C. A inserção do nutricionista na estratégia da saúde da família: o olhar de diferentes trabalhadores da saúde. Fam. Saúde Desenv. 2005.7(3): p.257-265.

  • Oliveira DC, Sa CP, Gomes AM, Ramos Rde S, Pereira NA, Santos WC. [Brazilian National Health Policy: health professionals' social representations]. Cad Saude Publica. 2008 Jan;24(1):197-206. doi: 10.1590/s0102-311x2008000100020. Portuguese.

    PubMed 18209848

  • ______. Secretaria de Atenção à Saúde. Departamento de Atenção Básica. Política Nacional de Atenção Básica. Brasília: Ministério da Saúde, 2006f. (Série A. Normas e Manuais Técnicos), (Série Pactos pela Saúde, v. 4).

  • Demarzo MMP. Mindfulness e Promoção da Saúde. RESC. 2015. 2(3): e82.

  • Keng SL, Smoski MJ, Robins CJ. Effects of mindfulness on psychological health: a review of empirical studies. Clin Psychol Rev. 2011 Aug;31(6):1041-56. doi: 10.1016/j.cpr.2011.04.006. Epub 2011 May 13.

    PubMed 21802619

Questions about this trial

What is this clinical trial studying?

A study testing TAU, TAU+MBHP and TAU+MB-EAT in people with Overweight and Obesity, run by Centro Mente Aberta de Mindfulness at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feeding Behaviour (time frame: Up to 3-month of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02893150, which also lists 68 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.

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