Mindful Moms, Mindful Meals (MMMM): A Patient-Oriented Randomized Controlled Trial Testing the Effects of a Mindful Eating Intervention on Infant Feeding Practices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Infant Responsive Feeding
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Mindfulness-Based Eating Awareness Training Postpartum (Behavioral)
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.
干预措施: Waitlist Mindfulness-Based Eating Awareness Training Postpartum (Behavioral)
结局指标
主要结局
Infant Responsive Feeding
时间窗: 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.
Maternal Mindful Eating
时间窗: 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.
次要结局
- Sustainability of Mindful Eating(3 months post-intervention)
- Dietary Quality(Baseline, at 4 weeks, and at 8 weeks after enrollment.)
- Behaviour Change Constructs(Baseline, at 4 weeks, and at 8 weeks after enrollment.)
- Sleep Quality(Baseline, at 4 weeks, and at 8 weeks after enrollment.)
- Weight Control Strategies(Baseline, at 4 weeks, and at 8 weeks after enrollment.)
- Mental Health(Baseline, at 4 weeks, and at 8 weeks after enrollment.)
研究者
Maryam Kebbe
Associate Professor
University of New Brunswick