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マインドフル・マムズ、マインドフル・ミールズ(MMMM)研究 (MMMM)

2026年9月23日 更新者:Maryam Kebbe、University of New Brunswick

マインドフル・ママ、マインドフル・ミールズ(MMMM):マインドフル・イーティング介入が乳幼児の授乳習慣に与える影響を検証する患者志向ランダム化比較試験

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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

72

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Dr. Maryam Kebbe, PhD, CLC
  • 電話番号:+1-506-451-6872
  • メール:maryam.kebbe@unb.ca

研究連絡先のバックアップ

  • 名前:Jasleen Kaur Dev, PhD Candidate
  • 電話番号:+1-778-385-6814
  • メール:jasleen.dev@unb.ca

研究場所

    • New Brunswick
      • Fredericton、New Brunswick、カナダ、E3B 4J9
        • 募集
        • University of New Brunswick
        • コンタクト:
        • 主任研究者:
          • Dr. Maryam Kebbe, PhD, CLC

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

19年~45年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Infant Responsive Feeding
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Dietary Quality
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Dr. Maryam Kebbe, PhD, CLC、University of New Brunswick

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年9月30日

一次修了 (推定)

2027年8月1日

研究の完了 (推定)

2028年8月1日

試験登録日

最初に提出

2025年9月12日

QC基準を満たした最初の提出物

2025年12月10日

最初の投稿 (実際)

2025年12月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月25日

QC基準を満たした最後の更新が送信されました

2026年9月23日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 2025-126

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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