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Mindful Eating Study for Adults With Diabetes and Weight Concerns in Hong Kong

9. juli 2026 oppdatert av: The Hong Kong Polytechnic University

Mindfulness-based Eating Awareness Training (MB-EAT) Intervention for Patients With Diabetes and Obesity: A Randomized Controlled Trial

Objectives: To assess the effect of a digital Mindfulness-Based Eating Awareness Training (MB-EAT) intervention on anthropometric measures, glycaemic control, eating behaviours, psychological health and hormones regulating stress and appetite in individuals with diabetes and obesity. Design: A randomized waitlist-controlled trial. Participants: A total of 120 participants (60 each in the intervention and control groups) with diabetes and obesity will be recruited via community partners and partnering endocrinology clinics. Interventions: The intervention group will be provided with an integrated programme of a 10-week digital MB-EAT course, alongside three individualized dietary consultations (scheduled at weeks 2, 5, and 10, each lasting one hour). This course will be delivered weekly through videos, audio tracks, and a series of mindfulness practice tasks to be completed at home. Outcome measures and data analysis: The primary outcomes will focus on changes in anthropometric measures, including weight loss, body mass index, waist circumference, and body fat percentage. Secondary outcomes will assess glycaemic control (measured by glycated haemoglobin), eating behaviours (including binge eating, eating control, mindful eating, food cravings, and dietary intake), psychological health (including diabetes-related distress, stress, anxiety, and depression), and hormones regulating stress and appetite (cortisol, ghrelin, leptin). The intervention's effects on these variables will be analysed at baseline, 3-month, and 6-month follow-ups using linear mixed model analysis. Expected results: It is anticipated that the MB-EAT group will demonstrate significant improvements in both primary and secondary outcomes compared to the waitlist group at both post-intervention and follow-up assessments.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Able to read and understand Chinese and/or Cantonese
  • With physician-diagnosed T2D for at least 1 year
  • Aged 45 to 64 years
  • Have a mobile phone or laptop
  • Having overweight/obesity (BMI ≥ 23.0 kg/m2) based on Asian criteria

Exclusion Criteria:

  • BMI < 23.0 kg/m2
  • Poor glycaemic control (HbA1c ≥9.0%)
  • Requiring insulin therapy, GLP-1 receptor agonists, or GLP-1 and GIP receptors dual agonist for glucose management
  • Have engaged in any form of mindfulness-based practice (e.g., meditation, yoga, etc.) within the past month before enrolment
  • With medical diagnosis of any neurological/psychiatric disorders (stroke, depression, generalized anxiety disorder, and epilepsy)
  • With active gastrointestinal diseases, renal failure, chronic kidney disease, undergoing renal replacement therapy, renal replacement therapy or cancer
  • With self-reported alcohol or drug addiction
  • Intake of medications (sedatives, antiepileptics, and antidepressants) that may affect cognition

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Control group
As an active control, participants in the control arm will receive three 1-hour personalized dietary consultations with a nutritionist/dietitian via Zoom or other online platforms at weeks 2, 5, and 10. Diabetes-specific dietary goals will be established according to clinical practice guidelines.
Atferdsmessig: control group
As an active control, participants in the control arm will receive three 1-hour personalized dietary consultations with a nutritionist/dietitian via Zoom or other online platforms at weeks 2, 5, and 10. Diabetes-specific dietary goals will be established according to clinical practice guidelines. Additionally, they will receive weekly general health information regarding diabetes-specific lifestyle modifications and will be instructed to refrain from engaging in any mindfulness-based practices during the study. To ensure they do not miss out on the benefits of the MB-EAT, participants will receive a training session on how to use MB-EAT and will gain full access to the program after completing the 12-month follow-up.
Eksperimentell: Intervention group
After randomisation, participants will be provided with an information sheet that contains information about the study, materials needed for the video-assisted practice (e.g., food for mindful eating exercises) and details of the contact person. In the orientation session, participants will be instructed on using REDCap, and an instruction video will be provided afterwards. The intervention will be delivered through 10 weekly videos (each ranged from 1-1.5 hours), audio tracks and a series of home mindfulness practice tasks to be completed within 10 weeks.
Atferdsmessig: MB-EAT
After randomisation, participants will be provided with an information sheet that contains information about the study, materials needed for the video-assisted practice (e.g., food for mindful eating exercises) and details of the contact person. In the orientation session, participants will be instructed on using REDCap, and an instruction video will be provided afterwards. The intervention will be delivered through 10 weekly videos (each ranged from 1-1.5 hours), audio tracks and a series of home mindfulness practice tasks to be completed within 10 weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Anthropometric measures
Tidsramme: At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline
Body weight, BMI and WC will be measured using calibrated equipment. Percentage body fat and muscle mass will be measured by using a multi-frequency segmental body composition analyzer (TANITA MC-780MA, Japan). Changes in muscle mass will be measured as a proxy for the safety of the intervention.
At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Glycaemic control
Tidsramme: At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline
HbA1c
At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline
Eating Behaviour
Tidsramme: At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline
Validated scales in Chinese will be used: 30-item Dutch Eating Behaviour Questionnaire; 16-item Binge Eating Scale; 20-item Salzburg Stress eating Scale; 23-item Mindful Eating Questionnaire; and 60-item Food Frequency Questionnaire
At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline
Psychological health
Tidsramme: At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline
Validated scales in Chinese will be used: 20-item Problem Areas in Diabetes Scale, the 21-item Beck Depression Inventory-II, the 21-item Beck Anxiety Inventory, and the 10-item Perceived Stress Scale
At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline
Hormones regulating stress and appetite
Tidsramme: At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline
serum concentrations of cortisol, ghrelin and leptin
At baseline (T0) and each follow-up assessment at 10-week (T1), 6-month (T2), and 12-month follow-up (T3) since baseline

Samarbeidspartnere og etterforskere

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Sponsor

The Hong Kong Polytechnic University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

31. august 2029

Studiet fullført (Antatt)

31. august 2029

Datoer for studieregistrering

Først innsendt

29. juni 2026

Først innsendt som oppfylte QC-kriteriene

7. juli 2026

Først lagt ut (Faktiske)

9. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 23241041

Plan for individuelle deltakerdata (IPD)

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NEI

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Nei

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