Feasibility and Preliminary Efficacy of a Theory-driven BALANCE Dietary Program Among Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
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.
详细描述
This study explores the effect of an individualized dietary intervention program based on the Capability, Opportunity, Motivation-Behavior (COM-B) theory on improving health outcomes in patients with type 2 diabetes mellitus (T2DM), including glycemic control, improvement in metabolic health indicators. The control group will implement a standardized diabetes management, including health guidance, WeChat group management, and supervision and management via a metabolic management center(MMC) mini-program. On the basis of the control group, the intervention group will implement a dietary intervention model based on the COM-B theory model and a TDF framework, including ① psychological capability education: intensified education on diabetes knowledge; ② physical capability education: intensified training in practical skills; ③ motivation management: action planning, behavior goal setting, reward mechanisms, and establishing role models; ④ support and supervision: empowerment management via a WeChat group, social support, problem solving, and guidance based on indicator monitoring on the clinician side of a health diet APP. We will observe dietary-related glycemic control, improvement in metabolic health indicators, as well as changes in dietary adherence, self-management ability, and self-efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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；
排除标准
- •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；
研究组 & 干预措施
The BALANCE dietary intervention
The intervention group will implement a BALANCE dietary intervention based on the COM-B theory model and a TDF framework, including ① psychological capability education: intensified education on diabetes knowledge; ② physical capability education: intensified training in practical skills for dietary management; ③ motivation management: action planning, behavior goal setting, problem solving, reward mechanisms, and establishing role models; ④ support and supervision: empowerment management via a WeChat group, social support, and guidance based on indicator monitoring on the clinician side of a mini-program.
干预措施: Psychological capability education (Behavioral)
The BALANCE dietary intervention
The intervention group will implement a BALANCE dietary intervention based on the COM-B theory model and a TDF framework, including ① psychological capability education: intensified education on diabetes knowledge; ② physical capability education: intensified training in practical skills for dietary management; ③ motivation management: action planning, behavior goal setting, problem solving, reward mechanisms, and establishing role models; ④ support and supervision: empowerment management via a WeChat group, social support, and guidance based on indicator monitoring on the clinician side of a mini-program.
干预措施: Physical capability education (Behavioral)
The BALANCE dietary intervention
The intervention group will implement a BALANCE dietary intervention based on the COM-B theory model and a TDF framework, including ① psychological capability education: intensified education on diabetes knowledge; ② physical capability education: intensified training in practical skills for dietary management; ③ motivation management: action planning, behavior goal setting, problem solving, reward mechanisms, and establishing role models; ④ support and supervision: empowerment management via a WeChat group, social support, and guidance based on indicator monitoring on the clinician side of a mini-program.
干预措施: motivation management (Behavioral)
The BALANCE dietary intervention
The intervention group will implement a BALANCE dietary intervention based on the COM-B theory model and a TDF framework, including ① psychological capability education: intensified education on diabetes knowledge; ② physical capability education: intensified training in practical skills for dietary management; ③ motivation management: action planning, behavior goal setting, problem solving, reward mechanisms, and establishing role models; ④ support and supervision: empowerment management via a WeChat group, social support, and guidance based on indicator monitoring on the clinician side of a mini-program.
干预措施: support and supervision (Behavioral)
usual care
A routine dietary management will be implemented, including health guidance, WeChat group management, and supervision and management
干预措施: A standardized diabetes care (Behavioral)
结局指标
主要结局
HbA1c
时间窗: before the intervention and from enrollment to the end of treatment at 12 and 24 weeks
HbA1c will be measured using High-Performance Liquid Chromatography (HPLC), the internationally recognized reference method for HbA1c quantification. Venous blood samples will be collected in EDTA-anticoagulated tubes and analyzed by ion-exchange HPLC, which separates hemoglobin fractions based on their interaction with a chromatography column. Results will be reported as a percentage (%) per NGSP/DCCT standards, with parallel reporting in mmol/mol per IFCC standards. All analyses will be performed in a certified laboratory participating in external quality assessment (EQA) programs to ensure inter-laboratory comparability and result accuracy.
次要结局
- FBG (Fasting Blood Glucose)(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- TG (Triglycerides)(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- TC (Total Cholesterol)(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- DKT (Diabetes Knowledge Test)(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- DSES (Diabetes Self-Efficacy Scale)(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- SDSCA (Summary of Diabetes Self-Care Activities)(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- Insulin Resistance Index(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- Insulin Sensitivity Index(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- Insulin C-peptide test(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- Oral Glucose Tolerance Test(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- High-Density Lipoprotein Cholesterol (HDL-C)(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- Low-Density Lipoprotein Cholesterol (LDL-C)(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- Weight(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- Height(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- BMI(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- Body fat percentage(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- Visceral fat area(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- Waist Circumference (WC)(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- Hip Circumference (HC)(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- Waist-hip ratio (WHR)(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- Dietary behaviour diary(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- Dietary adherence(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
- International Physical Activity Questionnaire-Short Form (IPAQ-SF)(before the intervention and from enrollment to the end of treatment at 12 and 24 weeks)
研究者
Meihua Ji
Associate Professor
Capital Medical University