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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
January 1, 1970
Hector Morillo Sarto et al. (7 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the effectiveness of a mindfulness eating (ME) program in reducing emotional eating among Spanish adults with overweight/obesity in primary care settings.

Results Summary

The study protocol outlines a planned evaluation of ME's impact on emotional eating, binge eating, anxiety, depression, and other outcomes, but results are not yet reported as it is a study protocol.

Population

Spanish adults with overweight/obesity from primary care health centers in Zaragoza, Spain.

Effective Dosage

Seven sessions delivered by a clinical psychologist (frequency not specified).

Duration

Not specified (follow-up measures planned at 1 year).

Interactions

None mentioned

Extracted Claims (12)
InterventionDirectionEndpointPopulationDosageImpactClaim #
mindfulness eating (ME) programme
decrease
emotional eating (EE)
adults with overweight/obesity in primary care (PC) settings
-
reduce
#1
mindfulness eating (ME) programme
neutral
external and restrained eating (DEBQ)
adults with overweight/obesity from four PC health centres
-
evaluate the effectiveness
#2
mindfulness eating (ME) programme
neutral
binge eating (Bulimic Investigatory Test Edinburgh)
adults with overweight/obesity from four PC health centres
-
evaluate the effectiveness
#3
mindfulness eating (ME) programme
neutral
eating disorder (Eating Attitude Test)
adults with overweight/obesity from four PC health centres
-
evaluate the effectiveness
#4
mindfulness eating (ME) programme
neutral
anxiety (General Anxiety Disorder-7)
adults with overweight/obesity from four PC health centres
-
evaluate the effectiveness
#5
mindfulness eating (ME) programme
neutral
depression (Patient Health Questionnaire-9)
adults with overweight/obesity from four PC health centres
-
evaluate the effectiveness
#6
mindfulness eating (ME) programme
neutral
mindful eating (Mindful Eating Scale)
adults with overweight/obesity from four PC health centres
-
evaluate the effectiveness
#7
mindfulness eating (ME) programme
neutral
dispositional mindfulness (Five Facet Mindfulness Questionnaire)
adults with overweight/obesity from four PC health centres
-
evaluate the effectiveness
#8
mindfulness eating (ME) programme
neutral
self-compassion (Self-Compassion Scale)
adults with overweight/obesity from four PC health centres
-
evaluate the effectiveness
#9
mindfulness eating (ME) programme
neutral
anthropometric measures
adults with overweight/obesity from four PC health centres
-
evaluate the effectiveness
#10
mindfulness eating (ME) programme
neutral
vital signs
adults with overweight/obesity from four PC health centres
-
evaluate the effectiveness
#11
mindfulness eating (ME) programme
neutral
blood tests
adults with overweight/obesity from four PC health centres
-
evaluate the effectiveness
#12
Abstract

INTRODUCTION: Little is known about the applicability of mindfulness-based interventions in Spanish adults with overweight/obesity. The objective of the present study protocol is to describe the methods that will be used in a cluster randomised trial (CRT) that aims to evaluate the effectiveness of a mindfulness eating (ME) programme to reduce emotional eating (EE) in adults with overweight/obesity in primary care (PC) settings. METHODS AND ANALYSIS: A CRT will be conducted with approximately 76 adults with overweight/obesity from four PC health centres (clusters) in the city of Zaragoza, Spain. Health centres matched to the average per capita income of the assigned population will be randomly allocated into two groups: 'ME +treatment as usual (TAU)' and 'TAU alone'. The ME programme will be composed of seven sessions delivered by a clinical psychologist, and TAU will be offered by general practitioners. The primary outcome will be EE measured by the Dutch Eating Behaviour Questionnaire (DEBQ) at post test as primary endpoint. Other outcomes will be external and restrained eating (DEBQ), binge eating (Bulimic Investigatory Test Edinburgh), eating disorder (Eating Attitude Test), anxiety (General Anxiety Disorder-7), depression (Patient Health Questionnaire-9), mindful eating (Mindful Eating Scale), dispositional mindfulness (Five Facet Mindfulness Questionnaire) and self-compassion (Self-Compassion Scale). Anthropometric measures, vital signs and blood tests will be taken. A primary intention-to-treat analysis on EE will be conducted using linear mixed models. Supplementary analyses will include secondary outcomes and 1-year follow-up measures; adjusted models controlling for sex, weight status and levels of anxiety and depression; the complier average causal effect of treatment; and the clinical significance of improvements. ETHICS AND DISSEMINATION: Positive results of this study may have a significant impact on one of the most important current health-related problems. Approval was obtained from the Ethics Committee of the Regional Authority. The results will be submitted to peer-reviewed journals, and reports will be sent to participants. TRIAL REGISTRATION NUMBER: NCT03927534 (5/2019).

Medical Subject Headings (MeSH)
AgedHumansMiddle AgedBulimiaEmotionsFeeding BehaviorMindfulnessObesityOverweightPrimary Health CareSpainRandomized Controlled Trials as Topic
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations14
Citations/Year2.3
Relative Citation Ratio1.27
NIH Percentile59.2%
Research Impact Scores
APT Score0.75
Weight Score1.76
Normalized Score0.67
Related Supplements
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