Mindful Moms, Mindful Meals (MMMM) Study

University of New Brunswick

Status: Enrolling

Conditions: Nutrition in Early Infancy; Nutrition Habits; Mindful Eating Intervention; Postpartum Nutrition

Treatments: Behavioral: Waitlist Mindfulness-Based Eating Awareness Training Postpartum; Behavioral: Mindfulness-Based Eating Awareness Training Postpartum

Study type: Interventional

Funder types: Other

Identifiers

NCT07282964

REB 2025-126

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 72 estimated patients

Sex: Female

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-Based Eating Awareness Training Postpartum

Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Waitlist Mindfulness-Based Eating Awareness Training Postpartum