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

9 juli 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

120

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / 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.
Beteende: 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.
Experimentell: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Anthropometric measures
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Glycaemic control
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Hong Kong Polytechnic University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

31 augusti 2029

Avslutad studie (Beräknad)

31 augusti 2029

Studieregistreringsdatum

Först inskickad

29 juni 2026

Först inskickad som uppfyllde QC-kriterierna

7 juli 2026

Första postat (Faktisk)

9 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 juli 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 23241041

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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