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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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Beijing Luhe Hospital, Capital Medical University
Beijing, China
Start Date
June 1, 2025
Primary Completion Date
December 1, 2025
Completion Date
December 1, 2025
Last Updated
March 16, 2026
30
ACTUAL participants
Psychological capability education
BEHAVIORAL
Physical capability education
BEHAVIORAL
motivation management
BEHAVIORAL
support and supervision
BEHAVIORAL
A standardized diabetes care
BEHAVIORAL
Lead Sponsor
Capital Medical University
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07433062