Effects of an APN-Led Intensive Individualized Lifestyle Modification Program in Adults with Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

A Feasibility Study of an APN-Led Intensive Individualized Lifestyle Modification Program on Body Composition and Metabolic Control Among Adults with Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260731003

Enrollment

Registered

2026-07-31

Start date

2025-01-15

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus Metabolic Dysfunction-Associated Steatotic Liver Disease Type 2 Diabetes Mellitus Metabolic Dysfunction-Associated Steatotic Liver Disease Lifestyle Modification Diabetes Self-Management Education and Support Advanced Practice Nursing Motivational Interviewing Telehealth Body Composition Glycated Hemoglobin A

Interventions

Participants receive a 12-week Advanced Practice Nurse (APN)-led intensive individualized lifestyle modification program. The intervention includes diabetes self-management education and support (DSME

Experimental Behavioral

APN-led Intensive Individualized Lifestyle Modification Program

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 60 years, 2. Diagnosed with type 2 diabetes mellitus, 3. Body mass index (BMI) of 23 kg/m2 or higher, 4. Diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD) confirmed by FibroScan (controlled attenuation parameter 215 dB/m or higher) or liver ultrasonography, 5. Able to read and understand the Thai language, 6. Own and are able to use a smartphone for telehealth communication and self-monitoring, 7. In the Preparation stage of behavior change, 8. Willing to participate, provide written informed consent, and comply with all study procedures.

Exclusion criteria

Exclusion criteria: 1. Excessive alcohol consumption (more than 420 g per week for men or more than 350 g per week for women, 2. History of malignancy or decompensated liver cirrhosis, 3. Heart failure or acute coronary syndrome, 4. Chronic kidney disease stage 4 or higher, 5. Pregnant or breastfeeding women, 6. Currently participating in another lifestyle intervention or weight management program, 7. Currently receiving weight-loss medications or dietary supplements intended for weight reduction, 8. Presence of a pacemaker or implanted metallic device that may interfere with body composition measurement by bioelectrical impedance analysis, 9. Any medical or psychological condition that, in the opinion of the investigator, may interfere with study participation, adherence to the intervention, or completion of the study.

Design outcomes

Primary

Measure	Time frame
Program feasibility and acceptability Week 12 Measured by participant recruitment rate, retention rate, intervention adherence, completion rate, and participant satisfaction using a structured questionnaire.	—

Secondary

Measure	Time frame
Program feasibility and acceptability Week 12 Measured by participant recruitment rate, retention rate, intervention adherence, completion rate, and participant satisfaction.,Body weight Baseline and Week 12 Body weight (kg) measured using a calibrated digital scale.	—

Countries

Thailand

Contacts

Public ContactNatphassorn Dermkhuntod

Faculty of Medicine Vajira Hospital, Navamindradhiraj University

natphassorn.der@gmail.com0924291924

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026