Feasibility and Preliminary Efficacy of a Theory-driven BALANCE Dietary Program Among Patients Wi… (NCT07472855) | Clinical Trial Compass
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
SexALL
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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 physicianï¼›
* Age 18-60 yearsï¼›
* Light physical labor in the past 6 months (work mainly involving standing or small amount of walking)ï¼›
* Willing to participate voluntarily, understand study content, and able to attend regular follow-upï¼›
Exclusion Criteria:
* Currently using weight-loss medicationsï¼›
* 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)ï¼›
* History of stroke or myocardial infarctionï¼›
* Other serious diseases including malignant tumors, psychiatric disorders, anorexia, or gastrointestinal diseasesï¼›
* Pregnancy, planning pregnancy, postpartum status, or breastfeedingï¼›
What they're measuring
1
HbA1c
Timeframe: before the intervention and from enrollment to the end of treatment at 12 and 24 weeks