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
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...
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| Format: | Article |
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BMJ Publishing Group
2019-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/11/e031327.full |
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| author | Jesus Montero-Marin Mayte Navarro-Gil Paola Herrera-Mercadal Alberto Barcelo-Soler Javier Garcia-Campayo Hector Morillo Sarto Bianca Pantilie |
| author_facet | Jesus Montero-Marin Mayte Navarro-Gil Paola Herrera-Mercadal Alberto Barcelo-Soler Javier Garcia-Campayo Hector Morillo Sarto Bianca Pantilie |
| author_sort | Jesus Montero-Marin |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-2d97774d17004853a7816fa34d068f17 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-2d97774d17004853a7816fa34d068f172024-12-12T22:25:10ZengBMJ Publishing GroupBMJ Open2044-60552019-11-0191110.1136/bmjopen-2019-031327Efficacy of a mindful-eating programme to reduce emotional eating in patients suffering from overweight or obesity in primary care settings: a cluster-randomised trial protocolJesus Montero-Marin0Mayte Navarro-Gil1Paola Herrera-Mercadal2Alberto Barcelo-Soler3Javier Garcia-Campayo4Hector Morillo Sarto5Bianca Pantilie65 Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Spain1 Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain3 Institute of Health Research of Aragon (IIS), Zaragoza, Spain1 Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain1 Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain1 Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain4 Oral and Maxillofacial Surgery Department, Miguel Servet University Hospital, Zaragoza, Aragón, SpainIntroduction 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).https://bmjopen.bmj.com/content/9/11/e031327.full |
| spellingShingle | Jesus Montero-Marin Mayte Navarro-Gil Paola Herrera-Mercadal Alberto Barcelo-Soler Javier Garcia-Campayo Hector Morillo Sarto Bianca Pantilie 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/9/11/e031327.full |
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