CompletedNot Applicable

Feasibility and Preliminary Efficacy of a Theory-driven BALANCE Dietary Program Among Patients With Type 2 Diabetes

China30 participantsStarted 2025-06-01

Plain-language summary

This study explores the effect of an individualized dietary intervention program based on COM-B theory on improving health outcomes in patients with T2DM, improvement in metabolic health indicators and an increased diabetes remission rate, as well as changes in dietary adherence, self-management ability, and self-efficacy.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meet 1999 WHO diagnostic criteria for type 2 diabetes mellitus (diabetes symptoms plus random plasma glucose ≥11.1 mmol/L, or fasting plasma glucose ≥7.0 mmol/L, or 2-hour plasma glucose ≥11.1 mmol/L after OGTT) Glycated hemoglobin (HbA1c) between 7% and 10%； * Stable glucose-lowering medication regimen as assessed by physician； * Age 18-60 years； * Light physical labor in the past 6 months (work mainly involving standing or small amount of walking)； * Willing to participate voluntarily, understand study content, and able to attend regular follow-up； Exclusion Criteria: * Currently using weight-loss medications； * Significant renal insufficiency (creatinine ≥1.5 mg/dL or 133 μmol/L)； * Significant liver dysfunction (ALT more than 2 times the upper limit of normal)； * History of stroke or myocardial infarction； * Other serious diseases including malignant tumors, psychiatric disorders, anorexia, or gastrointestinal diseases； * Pregnancy, planning pregnancy, postpartum status, or breastfeeding；

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

HbA1c

Timeframe: before the intervention and from enrollment to the end of treatment at 12 and 24 weeks

Trial details

NCT IDNCT07472855

SponsorCapital Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.