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Nutrition in Early InfancyMMMMNCT07282964

Mindful Moms, Mindful Meals (MMMM) Study

A study testing Mindfulness-Based Eating Awareness Training Postpartum and Waitlist Mindfulness-Based Eating Awareness Training Postpartum in people with Nutrition in Early Infancy and Nutrition Habits, run by University of New Brunswick at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Mindfulness-Based Eating Awareness Training Postpartum and Waitlist Mindfulness-Based Eating Awareness Training Postpartum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteCanada
Study dates
30 Sep 2025to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dr. Maryam Kebbe, PhD, CLC contact

+1-506-451-6872

maryam.kebbe@unb.ca

Jasleen Kaur Dev, PhD Candidate contact

+1-778-385-6814

jasleen.dev@unb.ca

Canada1 site, 1 recruiting
  • University of New Brunswick

    Fredericton, New Brunswick, E3B 4J9

    Dr. Maryam Kebbe, PhD, CLC, 506-451-6872, maryam.kebbe@unb.ca

    Dr. Maryam Kebbe, PhD, CLC

    Recruiting

Other trials in Canada

About this study

Official title: Mindful Moms, Mindful Meals (MMMM): A Patient-Oriented Randomized Controlled Trial Testing the Effects of a Mindful Eating Intervention on Infant Feeding Practices

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.

Read the detailed 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.

Being tested
Mindfulness-Based Eating Awareness Training Postpartum, Waitlist Mindfulness-Based Eating Awareness Training Postpartum
Keywords
Infant, Feeding Behavior, Postpartum Period, Diet, Mindful Eating, Nutrition
Medical subject headings
Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-Based Eating Awareness Training PostpartumBehavioural

    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.

  • Waitlist Mindfulness-Based Eating Awareness Training PostpartumBehavioural

    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.

Study groups in NCT07282964
Study groupRoleWhat they receive
InterventionExperimentalParticipants 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.
Receives: Behavioral: Mindfulness-Based Eating Awareness Training Postpartum
ControlActive comparatorParticipants 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.
Receives: Behavioral: Waitlist Mindfulness-Based Eating Awareness Training Postpartum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infant Responsive Feeding

    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.

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

  2. Maternal Mindful Eating

    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.

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

Secondary outcomes (6)
  1. Dietary Quality

    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.

    Measured: Baseline, at 4 weeks, and at 8 weeks after enrollment.

  2. Behaviour Change Constructs

    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).

    Measured: Baseline, at 4 weeks, and at 8 weeks after enrollment.

  3. Sleep Quality

    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.

    Measured: Baseline, at 4 weeks, and at 8 weeks after enrollment.

  4. Weight Control Strategies

    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.

    Measured: Baseline, at 4 weeks, and at 8 weeks after enrollment.

  5. Mental Health

    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.

    Measured: Baseline, at 4 weeks, and at 8 weeks after enrollment.

  6. Sustainability of Mindful Eating

    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.

    Measured: 3 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2025
  2. Study start30 Sep 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Waitlist-Control Randomized Controlled Trial
Masking
Single blind
Who is masked
Investigator
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07282964
Sponsor's protocol ID
2025-126
Acronym
MMMM
Status last verified
Sep 2026
First submitted
12 Sep 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kao TA, Ling J, Alanazi M, Atwa A, Liu S. Effects of mindfulness-based interventions on obesogenic eating behaviors: A systematic review and meta-analysis. Obes Rev. 2025 Mar;26(3):e13860. doi: 10.1111/obr.13860. Epub 2024 Nov 3.

    PubMed 39489689
  • Ayyala MS, Coughlin JW, Martin L, Henderson J, Ezekwe N, Clark JM, Appel LJ, Bennett WL. Perspectives of pregnant and postpartum women and obstetric providers to promote healthy lifestyle in pregnancy and after delivery: a qualitative in-depth interview study. BMC Womens Health. 2020 Mar 4;20(1):44. doi: 10.1186/s12905-020-0896-x.

    PubMed 32131832
  • Madray C, Richardson J, Hornsby P, Grello C, Drake E, Kellams A. Exploring the Unmet Needs of Postpartum Mothers: A Qualitative Study. J Perinat Educ. 2022 Apr 1;31(2):71-81. doi: 10.1891/JPE-2021-00009.

    PubMed 35386495
  • Brassard D, Elvidge Munene LA, St-Pierre S, Guenther PM, Kirkpatrick SI, Slater J, Lemieux S, Jessri M, Haines J, Prowse R, Olstad DL, Garriguet D, Vena J, Vatanpatast H, L'Abbe MR, Lamarche B. Development of the Healthy Eating Food Index (HEFI)-2019 measuring adherence to Canada's Food Guide 2019 recommendations on healthy food choices. Appl Physiol Nutr Metab. 2022 May;47(5):595-610. doi: 10.1139/apnm-2021-0415. Epub 2022 Jan 14.

    PubMed 35030038
  • Manafo E, Petermann L, Vandall-Walker V, Mason-Lai P. Patient and public engagement in priority setting: A systematic rapid review of the literature. PLoS One. 2018 Mar 2;13(3):e0193579. doi: 10.1371/journal.pone.0193579. eCollection 2018.

    PubMed 29499043
  • Leahy K, Berlin KS, Banks GG, Bachman J. The Relationship Between Intuitive Eating and Postpartum Weight Loss. Matern Child Health J. 2017 Aug;21(8):1591-1597. doi: 10.1007/s10995-017-2281-4.

    PubMed 28176035
  • Ward K, Herekar A, Wang P, Lindsay KL. Feasibility and Acceptability of a Mindfulness-Based Smartphone App among Pregnant Women with Obesity. Int J Environ Res Public Health. 2023 Apr 6;20(7):5421. doi: 10.3390/ijerph20075421.

    PubMed 37048035
  • Vieten C, Laraia BA, Kristeller J, Adler N, Coleman-Phox K, Bush NR, Wahbeh H, Duncan LG, Epel E. The mindful moms training: development of a mindfulness-based intervention to reduce stress and overeating during pregnancy. BMC Pregnancy Childbirth. 2018 Jun 1;18(1):201. doi: 10.1186/s12884-018-1757-6.

    PubMed 29859038
  • Tylka TL, Eneli IU, Kroon Van Diest AM, Lumeng JC. Which adaptive maternal eating behaviors predict child feeding practices? An examination with mothers of 2- to 5-year-old children. Eat Behav. 2013 Jan;14(1):57-63. doi: 10.1016/j.eatbeh.2012.10.014. Epub 2012 Nov 10.

    PubMed 23265403
  • Roberts LT, Carbonneau N, Goodman LC, Musher-Eizenman DR. Retrospective reports of childhood feeding in mother-daughter dyads. Appetite. 2020 Jun 1;149:104613. doi: 10.1016/j.appet.2020.104613. Epub 2020 Jan 24.

    PubMed 31987877
  • Furman D, Campisi J, Verdin E, Carrera-Bastos P, Targ S, Franceschi C, Ferrucci L, Gilroy DW, Fasano A, Miller GW, Miller AH, Mantovani A, Weyand CM, Barzilai N, Goronzy JJ, Rando TA, Effros RB, Lucia A, Kleinstreuer N, Slavich GM. Chronic inflammation in the etiology of disease across the life span. Nat Med. 2019 Dec;25(12):1822-1832. doi: 10.1038/s41591-019-0675-0. Epub 2019 Dec 5.

    PubMed 31806905
  • Faria-Schutzer DB, Surita FG, Rodrigues L, Turato ER. Eating Behaviors in Postpartum: A Qualitative Study of Women with Obesity. Nutrients. 2018 Jul 10;10(7):885. doi: 10.3390/nu10070885.

    PubMed 29996489

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-Based Eating Awareness Training Postpartum and Waitlist Mindfulness-Based Eating Awareness Training Postpartum in people with Nutrition in Early Infancy and Nutrition Habits, run by University of New Brunswick at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr. Maryam Kebbe, PhD, CLC (+1-506-451-6872, maryam.kebbe@unb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infant Responsive Feeding (time frame: Baseline, at 4 weeks, at 8 weeks after enrollment and 3 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07282964, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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