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

NCT07472855 | Completed DMC

• 1 other identifier: LHYY2025-YJZ010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

COM-B theory, type 2 diabetes, behaviour change technique

Outcome Measures

Primary Outcomes (1)

• HbA1c

  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.

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

Secondary Outcomes (23)

• 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

Study Arms (2)

The BALANCE dietary intervention

EXPERIMENTAL

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.

Behavioral: Psychological capability education; Behavioral: Physical capability education; Behavioral: motivation management; Behavioral: support and supervision

usual care

ACTIVE COMPARATOR

A routine dietary management will be implemented, including health guidance, WeChat group management, and supervision and management

Behavioral: A standardized diabetes care

Interventions

Psychological capability education BEHAVIORAL

Intensified education on diabetes knowledge

The BALANCE dietary intervention

Physical capability education BEHAVIORAL

Intensified training in practical skills for dietary management

The BALANCE dietary intervention

motivation management BEHAVIORAL

action planning, behavior goal setting, problem solving, reward mechanisms, and establishing role models

The BALANCE dietary intervention

support and supervision BEHAVIORAL

empowerment management via a WeChat group, social support, and guidance based on indicator monitoring on the clinician side of a mini-program

The BALANCE dietary intervention

A standardized diabetes care BEHAVIORAL

a routine dietary management model will be implemented, including health guidance, WeChat group management, and supervision and management

usual care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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；

Sponsors & Collaborators

• Capital Medical University: lead
• The Luhe Teaching Hospital of the Capital Medical University: collaborator

Study Sites (1)

Beijing Luhe Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Palliative Care; Organization and Administration

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Health Services Administration

Study Officials

• Ji Meihua

  Capital Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: For the control group, a routine dietary management model will be implemented, including health guidance, WeChat group management, and supervision and management; on the basis of the control group, 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. At 3 and 6 months after the intervention, we will observe dietary-related glycaemic control, improvement in metabolic health indicators, and diabetes remission, as well as changes in dieta

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 16, 2026
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)