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Исследование «Внимательные мамы, внимательное питание» (MMMM) (MMMM)

23 сентября 2026 г. обновлено: Maryam Kebbe, University of New Brunswick

Осознанные мамы, осознанное питание (MMMM): Ориентированное на пациента рандомизированное контролируемое исследование, проверяющее влияние интервенции осознанного питания на практики кормления младенцев

The goal of this clinical trial is to learn whether a Mindfulness-Based Eating Awareness Training Postpartum (MB-EAT-P) program can improve infant feeding practices and maternal eating behaviors. Researchers will compare participants who receive the MB-EAT-P program immediately to those who receive it after an 8-week waitlist period. Participants in the intervention group will attend weekly 2-hour MB-EAT-P sessions for 8 weeks and practice mindfulness and mindful eating at home. Participants in both groups will participate in a recorded mealtime observations with their infant and complete surveys and dietary recalls at baseline, midpoint, and post-intervention. This study is patient-oriented and co-developed with a Parent Advisory Committee to ensure relevance to postpartum individuals.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

Background. Postpartum life may lead to suboptimal nutrition behaviors/habits. Mothers have reported an unbalanced diet postpartum, defined as insufficient intake of key food groups i.e., fruits, veggies, grain foods, dairy and meat, which is directly linked to obesity, diabetes, and cancer. Maternal eating behaviours also contribute to child feeding practices, which in turn shape their lifelong eating patterns. Mindful eating can help struggling mothers to re-balance their nutrition by increasing awareness of choices, reducing stress, and fostering a greater connection to bodily cues, such as hunger and fullness cues. Previous literature on mindful eating has focused on the pregnant population and found that mindfulness-based interventions are feasible and acceptable, can reduce stress and overeating during pregnancy, and may support healthier postpartum weight outcomes through intuitive eating practices. The effects of postpartum mindful eating interventions on mothers' diet and feeding of infants remain unknown.

Objectives. The Mindful Moms, Mindful Meals (MMMM) study aims to evaluate the effects of a Mindfulness-Based Eating Awareness Training Postpartum (MB-EAT-P) intervention on infant feeding practices and maternal eating behaviors.

Research Questions.

  • Does MB-EAT-P improve mothers' recognition of infant hunger and satiety cues?
  • Does MB-EAT-P enhance maternal mindful eating?
  • Does MB-EAT-P improve dietary quality of mother and infant?
  • Does MB-EAT-P improve behaviour change constructs (e.g., knowledge, confidence, self-efficacy?)
  • Does MB-EAT-P improve sleep quality, weight control, and anxiety symptoms?
  • Does MB-EAT-P promote sustainable mindful eating and responsive feeding behaviours 3-months post-intervention?

Methodological Approach. This parallel, waitlist-control randomized controlled trial will adapt an 8-week mindful eating intervention for postpartum participants. Approximately 72 participants, aged 19-45 years, with infants aged 6-12 months who have started solid foods, will be recruited from social media, community outreach, and local health clinics in Fredericton, NB. Exclusion criteria include active eating disorders, substance use disorders, unmanaged medical/mental health conditions such as diagnosed postpartum depression or anxiety, cognitive impairments, recent trauma or untreated post-traumatic stress disorder, participation in a similar program within 12 months, strict dietary regimens, recent major surgery that affects nutritional intake, preterm infants, or no English proficiency.

Mothers will be randomized to either the intervention group or a control group using REDCap®. The intervention group will begin the MB-EAT-P program immediately upon enrollment, participating in 2-hour weekly group sessions over eight weeks, guided by MB-EAT certified instructor, with supplemental at-home mindfulness practices. Sessions will cover topics such as transitioning from breastfeeding and formula-feeding to solid foods, hunger and satiety awareness, recognition and management of emotional and mindless eating, and mindful eating strategies tailored for the postpartum period, including infancy. Meanwhile, the control group will be waitlisted for eight weeks. After the waitlist period, the control group will receive the intervention materials via the MMMM website, including recordings of guided mindful eating meditations, session worksheets, and responsive feeding infographics.

Phenotypic assessments will occur at the University of New Brunswick by telephone and/or online. Data will be collected at baseline, 4 weeks (midpoint), 8 weeks (post-intervention) and 3-months post-intervention. Infant feeding practices will be observed, using the validated Responsiveness to Child Feeding Cues Scale, during a recorded individual mealtime session in the PEADS Lab Metabolic Kitchen. The Mindful Eating Scale (MES) and Mindful Eating Behavior Scale (MEBS) will measure maternal mindful eating. Other questionnaires will measure maternal and infant feeding, weight control strategies, sleep, and mental health. Dietary quality of mothers and infants will be measured using the Healthy Eating Food Index and the WHO Infant and Young Child Feeding Indicators, respectively, derived from a 24-hour dietary recall.

Infant feeding practices, maternal eating behaviours, and dietary quality are among the top priorities for mothers. Our outcomes draw from this literature, as well as the priorities identified by moms in our Parent Advisory Committee (PAC). Specifically, the investigators established a PAC consisting of five diverse postpartum mothers from across Canada following the Canadian Institutes for Health Research recommendations for patient engagement. PAC mothers have collaborated (level 4 of 5 of the IAP2) with the research team by contributing to the development of MB-EAT-P session materials as well as informed session timings, postpartum specific programming, MMMM website and child-minding volunteer program.

Statistical Analysis. A repeated measures analysis of covariance (ANCOVA) will be conducted to evaluate the interaction between time (three measurements) and group (intervention vs. control). Based on a repeated measures within-between group interaction (ie. whether the pattern of change over time differs between groups), and assuming a small-to-medium effect size (f = 0.2), α = 0.05, and 95% power, 66 participants (28 per group) are required; to account for an anticipated ~10% drop-out rate, 72 participants (36 per group) will be recruited. A comprehensive analysis of 32 studies reported pooled effect sizes ranging approximately from f = 0.11 to f = 0.35, indicating small to moderate improvements in mindless eating behaviors such as controlled eating, fullness awareness, and impulsive food choices. The effects on stress-related eating behaviors, including emotional and binge eating, were generally smaller and less consistent across studies. However, an effect size of f = 0.32 for fullness awareness and f = 0.25 for long-term improvements in hunger eating were reported in adults, reflecting a medium-sized effect in the context of mindful eating interventions, suggesting an f = 0.20 for MMMM is appropriate yet conservative for an infant population.

Expected Outcomes. This study will generate evidence on how mindful eating interventions, like MB-EAT-P, may enhance maternal and infant feeding practices. Our findings may inform the development of public health programs to promote lifelong mindful eating and feeding habits.

Тип исследования

Интервенционный

Регистрация (Оцененный)

72

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Dr. Maryam Kebbe, PhD, CLC
  • Номер телефона: +1-506-451-6872
  • Электронная почта: maryam.kebbe@unb.ca

Учебное резервное копирование контактов

  • Имя: Jasleen Kaur Dev, PhD Candidate
  • Номер телефона: +1-778-385-6814
  • Электронная почта: jasleen.dev@unb.ca

Места учебы

    • New Brunswick
      • Fredericton, New Brunswick, Канада, E3B 4J9
        • Рекрутинг
        • University of New Brunswick
        • Контакт:
          • Dr. Maryam Kebbe, PhD, CLC
          • Номер телефона: 506-451-6872
          • Электронная почта: maryam.kebbe@unb.ca
        • Главный следователь:
          • Dr. Maryam Kebbe, PhD, CLC

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 19 лет до 45 лет (Взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Женский

Описание

Inclusion Criteria:

  • Age between 19 and 45 years.
  • Have started or plan to start solid foods for their baby by the time of enrollment
  • Have an infant aged 6 to 12 months
  • Willing to participate in a recorded mealtime observation for the study
  • Willing to complete an 8-week MB-EAT-P intervention, including homework assignments
  • Have an infant born at or after 37 weeks of gestation.

Exclusion Criteria:

General

  • Planning to move in the next two months
  • Medically diagnosed with an active eating disorder (e.g., Anorexia, Bulimia, Binge Eating Disorder)
  • Diagnosed with an unmanaged chronic medical condition affecting diet (e.g., uncontrolled diabetes, celiac disease, severe GI disorders, kidney disease, sleep apnea, PCOS)
  • Diagnosed with unmanaged postpartum depression or anxiety
  • Diagnosed with iron-deficiency anemia with extreme fatigue or weakness
  • Substance use disorder (e.g., alcohol or drug addiction)
  • Cognitive impairments affecting memory, attention, or comprehension (e.g., dementia, brain injury)
  • Following a strict formal diet or weight loss program
  • Enrolled in a weight loss or mindfulness-based program in the past 12 months
  • Recovering from major surgery or experiencing an acute medical crisis (e.g., bariatric surgery)
  • Experiencing recent trauma or untreated PTSD

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Intervention

Participants in this group will take part in an 8-week, tailored Mindfulness-Based Eating Awareness Training Postpartum (MB-EAT-P) program. Weekly sessions will include mindfulness meditations, training in hunger and satiety awareness, responsive feeding education, light-intensity physical activity, and food tasting experiences. In addition to the group sessions, participants will be encouraged to engage in at-home practices, including mindfulness meditations, mindful eating, responsive feeding techniques, and journaling their experiences to support reflection and integration of the training into daily life.

Mindfulness-Based Eating Awareness Training Postpartum (MB-EAT-P) is an 8-week, patient-oriented intervention co-developed with a Parent Advisory Committee. Designed for postpartum individuals, it integrates mindfulness practices, responsive feeding education, and experiential learning. Weekly sessions include guided meditations, mindful eating exercises, infant feeding strategies, and reflective journaling. Activities cover hunger/satiety cues, emotional balance, cultural feeding practices, and light physical activity. MB-EAT-P stands out for its postpartum-specific design, parent-led development, and holistic approach to maternal-infant well-being.

The intervention group receives the full program following the baseline visit, in an in-person group setting.

Активный компаратор: Control

Participants in the control group will receive access to the Mindfulness-Based Eating Awareness Training Postpartum (MB-EAT-P) program following the initial 8-week period. This self-guided version of the program will be delivered through the MMMM website and will include recorded sessions, meditation scripts, worksheets, and all core components of the intervention. These components encompass mindfulness meditations, hunger and satiety awareness training, responsive feeding education, light-intensity physical activity guidelines, and food tasting guidance.

Mindfulness-Based Eating Awareness Training Postpartum (MB-EAT-P) is an 8-week, patient-oriented intervention co-developed with a Parent Advisory Committee. Designed for postpartum individuals, it integrates mindfulness practices, responsive feeding education, and experiential learning. Weekly sessions include guided meditations, mindful eating exercises, infant feeding strategies, and reflective journaling. Activities cover hunger/satiety cues, emotional balance, cultural feeding practices, and light physical activity. The control group will not receive any components of the intervention until after the final clinical visit. MB-EAT-P stands out for its postpartum-specific design, parent-led development, and holistic approach to maternal-infant well-being.

The control group will then receive the full program post-study via the MMMM website in a self-guided format with recorded sessions, scripts, and worksheets.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Infant Responsive Feeding
Временное ограничение: Baseline, at 4 weeks, at 8 weeks after enrollment and 3 months post-intervention

Responsive Feeding is defined as a caregiver's ability to recognize and appropriately respond to their infant's hunger and satiety cues in a timely, supportive, and developmentally appropriate manner. It includes offering food when the infant shows hunger, allowing self-regulation, and avoiding coercive feeding. Infant cues will be assessed using the Responsiveness to Child Feeding Cues Scale (RCFCS), an observational coding system rating hunger and satiety cues (early, active, late), engagement, affect, and physical disposition. Cue strength is rated 1-5, with late cues coded present (1), absent (0), or can't tell (6). Responsiveness reflects how accurately and promptly caregivers respond to these cues, rather than cue strength alone. Composite measures include infant receptiveness (balance of hunger vs. fullness cues) and feeding engagement (percentage of time engaged with feeding). Trained coders will code video-recorded meals using the standardized RCFCS manual.

Baseline, at 4 weeks, at 8 weeks after enrollment and 3 months post-intervention
Maternal Mindful Eating
Временное ограничение: Baseline, at 4 weeks, at 8 weeks after enrollment and 3 months post-intervention

Mindful Eating is defined as non-judgmental awareness of physical and emotional sensations during eating, including hunger, satiety, taste, and emotional triggers. In this study, maternal mindful eating will be assessed using two validated tools: the Mindful Eating Questionnaire (MEQ) and the Mindful Eating Behavior Scale (MEBS). The MEQ evaluates dimensions such as awareness, disinhibition, and emotional eating, with scores ranging from 1 to 4, where higher scores reflect more mindful eating. The MEBS measures behavioral engagement in mindful eating practices, with scores from 1 to 5, with higher scores indicating greater mindful eating behavior. Together, the MEQ and MEBS provide a multidimensional understanding of how postpartum individuals engage with food and feeding in a mindful, intentional way, capturing both attitudinal and behavioral aspects of mindful eating.

Baseline, at 4 weeks, at 8 weeks after enrollment and 3 months post-intervention

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Dietary Quality
Временное ограничение: Baseline, at 4 weeks, and at 8 weeks after enrollment.

Dietary quality is defined as the overall nutritional adequacy and alignment of food intake with dietary guidelines. Maternal dietary quality will be assessed using the Healthy Eating Food Index (HEFI) based on ASA24 dietary recalls, which evaluates intake across food groups and nutrients. HEFI scores range from 0 to 80, with higher scores reflecting better alignment with recommendations. Infant dietary quality will be assessed using the WHO Infant and Young Child Feeding (IYCF) Indicators, which capture dietary diversity (0-7 food groups), meal frequency, and breastfeeding status. Together, the HEFI and IYCF provide a comprehensive assessment of maternal and infant nutritional behaviors and adherence to recommended feeding standards.

Baseline, at 4 weeks, and at 8 weeks after enrollment.
Behaviour Change Constructs
Временное ограничение: Baseline, at 4 weeks, and at 8 weeks after enrollment.

The investigators will examine whether MB-EAT-P improves behaviour change constructs (e.g., knowledge, confidence, self-efficacy) assessed using the Maternal Self-Efficacy Questionnaire for Solid Feeding (MSEQ-SF) and the InFANT Program Questionnaire. The MSEQ-SF captures maternal confidence and self-efficacy across three domains: (1) responsive feeding (ability to recognize hunger/satiety cues; range 0-20), (2) capability to feed (providing healthy food and encouraging intake; range 5-25), and (3) food-related decisions (confidence in making appropriate feeding choices; range 0-8). The InFANT Program Questionnaire assesses nutrition knowledge (12 items scored on a 4-point agreement scale, dichotomized into correct/incorrect) and parental confidence in promoting healthy eating, limiting unhealthy foods, and providing healthy settings (scored on a 5-point confidence scale).

Baseline, at 4 weeks, and at 8 weeks after enrollment.
Sleep Quality
Временное ограничение: Baseline, at 4 weeks, and at 8 weeks after enrollment.

The investigators will examine whether MB-EAT-P improves sleep quality in mothers. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

Baseline, at 4 weeks, and at 8 weeks after enrollment.
Weight Control Strategies
Временное ограничение: Baseline, at 4 weeks, and at 8 weeks after enrollment.

The investigators will examine whether MB-EAT-P improves weight control strategies. Weight control strategies will be assessed using the Weight Control Strategies Scale (WCSS). The WCSS includes subscales for dietary choices, self-monitoring, and physical activity, with scores ranging from 0 to 4 per item; higher scores indicate more frequent use of weight control strategies.

Baseline, at 4 weeks, and at 8 weeks after enrollment.
Mental Health
Временное ограничение: Baseline, at 4 weeks, and at 8 weeks after enrollment.

The investigators will examine whether MB-EAT-P improves mental health symptoms such as postpartum anxiety. Mental health will be assessed using the Symptom Checklist-90 (SCL-90). The SCL-90 contains 90 items scored from 0 to 4, producing subscale scores (e.g., Depression, Anxiety, Somatization) and a Global Severity Index (GSI); higher scores indicate greater psychological distress.

Baseline, at 4 weeks, and at 8 weeks after enrollment.
Sustainability of Mindful Eating
Временное ограничение: 3 months post-intervention

Self-Regulation of Eating Behaviour Questionnaire (SREBQ) will be administered 3 months post intervention to assess sustainability of Mindful Eating behaviours. SREBQ is scored on a scale of 1-5 for five questions. The score ranges between 25-5 with higher score indicating better self-regulation of Mindful Eating Behaviour.

3 months post-intervention

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Следователи

  • Главный следователь: Dr. Maryam Kebbe, PhD, CLC, University of New Brunswick

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

30 сентября 2025 г.

Первичное завершение (Оцененный)

1 августа 2027 г.

Завершение исследования (Оцененный)

1 августа 2028 г.

Даты регистрации исследования

Первый отправленный

12 сентября 2025 г.

Впервые представлено, что соответствует критериям контроля качества

10 декабря 2025 г.

Первый опубликованный (Действительный)

15 декабря 2025 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

25 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

23 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 2025-126

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .