NCT07472855

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	Psychological capability education	Intensified education on diabetes knowledge
BEHAVIORAL	Physical capability education	Intensified training in practical skills for dietary management
BEHAVIORAL	motivation management	action planning, behavior goal setting, problem solving, reward mechanisms, and establishing role models
BEHAVIORAL	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	A standardized diabetes care	a routine dietary management model will be implemented, including health guidance, WeChat group management, and supervision and management

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: China