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Estudio MMMM: Mamás Conscientes, Comidas Conscientes (MMMM)

23 de septiembre de 2026 actualizado por: Maryam Kebbe, University of New Brunswick

Mindful Moms, Mindful Meals (MMMM): Un ensayo controlado aleatorizado centrado en el paciente que evalúa los efectos de una intervención de alimentación consciente en las prácticas de alimentación infantil

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

72

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Dr. Maryam Kebbe, PhD, CLC
  • Número de teléfono: +1-506-451-6872
  • Correo electrónico: maryam.kebbe@unb.ca

Copia de seguridad de contactos de estudio

  • Nombre: Jasleen Kaur Dev, PhD Candidate
  • Número de teléfono: +1-778-385-6814
  • Correo electrónico: jasleen.dev@unb.ca

Ubicaciones de estudio

    • New Brunswick
      • Fredericton, New Brunswick, Canadá, E3B 4J9
        • Reclutamiento
        • University of New Brunswick
        • Contacto:
          • Dr. Maryam Kebbe, PhD, CLC
          • Número de teléfono: 506-451-6872
          • Correo electrónico: maryam.kebbe@unb.ca
        • Investigador principal:
          • Dr. Maryam Kebbe, PhD, CLC

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

19 años a 45 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Femenino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

Comparador activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Infant Responsive Feeding
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dietary Quality
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Dr. Maryam Kebbe, PhD, CLC, University of New Brunswick

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de septiembre de 2025

Finalización primaria (Estimado)

1 de agosto de 2027

Finalización del estudio (Estimado)

1 de agosto de 2028

Fechas de registro del estudio

Enviado por primera vez

12 de septiembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

10 de diciembre de 2025

Publicado por primera vez (Actual)

15 de diciembre de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2025-126

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .