Clinical trial NCT03927534: Efficacy of a Mindful-eating Program to Reduce Emotional Eating
Official title: Efficacy of a Mindful Eating Program to Reduce Emotional Eating in Patients Suffering From Overweight or Obesity in Primary Care Settings: a Cluster Randomized Controlled Clinical Trial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Obesity
Overweight
Mindful Eating
Primary Care
Randomized controlled trial (RCT)
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
Collaborators: name: Dharamsala Institute of Mindfulness and Psychotherapy of Zaragoza
First posted: 2019-04-25
Enrollment: 76
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mindfulness-Based Interventions have been applied in different fields to improve physical and psychological health. However, little is known about its applicability and effectiveness in Spanish adults with overweight and obesity. The aim of the present study protocol is to evaluate the feasibility and efficacy of an adapted MBI programme to reduce emotional eating in adults with overweight and obesity in primary care (PC) settings.

Detailed description: This study is a multi-centre, two-armed randomized controlled trial (RCT), with pre-treatment, post-treatment and 1-year follow-up measures, and a 1:1 allocation rate between groups. Patients from four mental health units in Zaragoza (Spain) will be randomly assigned to two different parallel conditions, with one psychological intervention group ('ME + TAU') and usual treatment ('TAU alone') managed by their general practitioner (GP), to test the superiority of 'ME + TAU' provision compared with 'TAU alone' provision. For ethical reasons, those patients allocated to 'TAU alone' will be offered the ME programme after finishing the trial at 1-year follow-up.

Eligibility criteria: Inclusion Criteria:

* Age between 45-75 years
* Have overweight or obesity condition based in BMI (Body Mass Index). Individuals with BMI of 25 or more.
* Have two of these three risk: sedentary lifestyle, poor diet and binge episodes.
* Ability to understand oral and written Spanish.
* Willingness to participate in the study and signing informed consent.

Exclusion Criteria:

* Any diagnosis of a disease that may affect the central nervous system (brain condition, traumatic brain injury, dementia, etc).
* Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, etc.), except for anxiety disorder or personality disorders.
* Presence of delusional ideas or hallucinations whether consistent or not with mood.
* Suicide risk.

Primary outcomes:
measure: The Dutch Eating Behavior Questionnaire
timeFrame: Baseline in experimental and control groups.
measure: The Dutch Eating Behavior Questionnaire
timeFrame: Post-treatment 8 weeks from baseline in experimental and control groups
measure: The Dutch Eating Behavior Questionnaire
timeFrame: twelve-months follow-up in experimental and control groups
Secondary outcomes:
measure: Sociodemographic data Gender, age, marital status, education, occupation, economical level
timeFrame: Baseline in experimental and control groups
measure: Five Facet Mindfulness Questionnaire
timeFrame: Baseline in experimental and control groups
measure: Five Facet Mindfulness Questionnaire
timeFrame: Post-treatment 8 weeks from baseline in experimental and control groups
measure: Five Facet Mindfulness Questionnaire
timeFrame: twelve-months follow-up in experimental and control groups
measure: Self-Compassion Scale
timeFrame: Baseline in experimental and control groups
measure: Self-Compassion Scale
timeFrame: Post-treatment 8 weeks from baseline in experimental and control groups
measure: Self-Compassion Scale
timeFrame: twelve-months follow-up in experimental and control groups
measure: Mindful Eating Scale
timeFrame: Baseline in experimental and control groups
measure: Mindful Eating Scale
timeFrame: Post-treatment 8 weeks from baseline in experimental and control groups
measure: Mindful Eating Scale
timeFrame: twelve-months follow-up in experimental and control groups
measure: Bulimic Investigatory Test
timeFrame: Baseline in experimental and control groups
measure: Bulimic Investigatory Test
timeFrame: Post-treatment 8 weeks from baseline in experimental and control groups
measure: Bulimic Investigatory Test
timeFrame: twelve-months follow-up in experimental and control groups
measure: Eating Attitude test (EAT-26)
timeFrame: Baseline in experimental and control groups
measure: Eating Attitude test (EAT-26)
timeFrame: Post-treatment 8 weeks from baseline in experimental and control groups
measure: Eating Attitude test (EAT-26)
timeFrame: twelve-months follow-up in experimental and control groups
measure: Weight
timeFrame: Baseline in experimental and control groups
measure: Weight
timeFrame: twelve-months follow-up in experimental and control groups
measure: Abdominal perimeter
timeFrame: Baseline in experimental and control groupsw-up in experimental and control groups
measure: Abdominal perimeter
timeFrame: twelve-months follow-up in experimental and control groups
measure: Height
timeFrame: Baseline in experimental and control groups
measure: Height
timeFrame: twelve-months follow-up in experimental and control groups
measure: Cholesterol total
timeFrame: Baseline in experimental and control groups
measure: Cholesterol total
timeFrame: twelve-months follow-up in experimental and control groups
measure: LDL
timeFrame: Baseline in experimental and control groups
measure: LDL
timeFrame: twelve-months follow-up in experimental and control groups
measure: HDL
timeFrame: Baseline in experimental and control groups
measure: HDL
timeFrame: twelve-months follow-up in experimental and control groups
measure: Glucose
timeFrame: Baseline in experimental and control groups
measure: Glucose
timeFrame: twelve-months follow-up in experimental and control groups
measure: Alanine aminotransferase
timeFrame: Baseline in experimental and control groups
measure: Alanine aminotransferase
timeFrame: twelve-months follow-up in experimental and control groups
measure: Glycated haemoglobin
timeFrame: Baseline in experimental and control groups
measure: Glycated haemoglobin
timeFrame: twelve-months follow-up in experimental and control groups
measure: General Anxiety Disorder
timeFrame: Baseline in experimental and control groups
measure: General Anxiety Disorder
timeFrame: twelve-months follow-up in experimental and control groups
measure: Patient Health Questionnaire
timeFrame: Baseline in experimental and control groups
measure: Patient Health Questionnaire
timeFrame: twelve-months follow-up in experimental and control groups
measure: The diastolic blood pressure (DBP) and the systolic blood pressure (SBP)
timeFrame: Baseline in experimental and control groups
measure: The diastolic blood pressure (DBP) and the systolic blood pressure (SBP)
timeFrame: twelve-months follow-up in experimental and control groups
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Department of Psychiatry. Miguel Servet University Hospital
Study officials:
affiliation: Miguel Servet Hospital and University of Zaragoza
name: Javier García-Campayo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rossner S. Obesity: the disease of the twenty-first century. Int J Obes Relat Metab Disord. 2002 Dec;26 Suppl 4:S2-4. doi: 10.1038/sj.ijo.0802209.
citation: Mann T, Tomiyama AJ, Westling E, Lew AM, Samuels B, Chatman J. Medicare's search for effective obesity treatments: diets are not the answer. Am Psychol. 2007 Apr;62(3):220-33. doi: 10.1037/0003-066X.62.3.220.
citation: Holzel BK, Lazar SW, Gard T, Schuman-Olivier Z, Vago DR, Ott U. How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective. Perspect Psychol Sci. 2011 Nov;6(6):537-59. doi: 10.1177/1745691611419671.
citation: Kristeller JL, Hallett CB. An Exploratory Study of a Meditation-based Intervention for Binge Eating Disorder. J Health Psychol. 1999 May;4(3):357-63. doi: 10.1177/135910539900400305.
citation: Medina WL, Wilson D, de Salvo V, Vannucchi B, de Souza EL, Lucena L, Sarto HM, Modrego-Alarcon M, Garcia-Campayo J, Demarzo M. Effects of Mindfulness on Diabetes Mellitus: Rationale and Overview. Curr Diabetes Rev. 2017;13(2):141-147. doi: 10.2174/1573399812666160607074817.
citation: Rosenzweig S, Reibel DK, Greeson JM, Edman JS, Jasser SA, McMearty KD, Goldstein BJ. Mindfulness-based stress reduction is associated with improved glycemic control in type 2 diabetes mellitus: a pilot study. Altern Ther Health Med. 2007 Sep-Oct;13(5):36-8.
citation: Miller CK, Kristeller JL, Headings A, Nagaraja H, Miser WF. Comparative effectiveness of a mindful eating intervention to a diabetes self-management intervention among adults with type 2 diabetes: a pilot study. J Acad Nutr Diet. 2012 Nov;112(11):1835-42. doi: 10.1016/j.jand.2012.07.036.
citation: Fanning J, Osborn CY, Lagotte AE, Mayberry LS. Relationships between dispositional mindfulness, health behaviors, and hemoglobin A1c among adults with type 2 diabetes. J Behav Med. 2018 Dec;41(6):798-805. doi: 10.1007/s10865-018-9938-3. Epub 2018 May 25.
citation: Mantzios M, Wilson JC. Mindfulness, Eating Behaviours, and Obesity: A Review and Reflection on Current Findings. Curr Obes Rep. 2015 Mar;4(1):141-6. doi: 10.1007/s13679-014-0131-x.
citation: Godsey J. The role of mindfulness based interventions in the treatment of obesity and eating disorders: an integrative review. Complement Ther Med. 2013 Aug;21(4):430-9. doi: 10.1016/j.ctim.2013.06.003. Epub 2013 Jul 9.
citation: Mason AE, Epel ES, Kristeller J, Moran PJ, Dallman M, Lustig RH, Acree M, Bacchetti P, Laraia BA, Hecht FM, Daubenmier J. Effects of a mindfulness-based intervention on mindful eating, sweets consumption, and fasting glucose levels in obese adults: data from the SHINE randomized controlled trial. J Behav Med. 2016 Apr;39(2):201-13. doi: 10.1007/s10865-015-9692-8. Epub 2015 Nov 12.
citation: Morillo Sarto H, Barcelo-Soler A, Herrera-Mercadal P, Pantilie B, Navarro-Gil M, Garcia-Campayo J, Montero-Marin J. Efficacy of a mindful-eating programme to reduce emotional eating in patients suffering from overweight or obesity in primary care settings: a cluster-randomised trial protocol. BMJ Open. 2019 Nov 21;9(11):e031327. doi: 10.1136/bmjopen-2019-031327.