Resources-Oriented Intervention for Pre-diabetes

Efficacy of the Resources-Oriented Salutogenic (ROS) Intervention on Sense of Coherence Among Pre-diabetes Population: A Pilot Randomized Controlled Trial

This study is testing a new program to help people with pre-diabetes in China manage their condition better by improving their coping skills and health knowledge.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Hong Kong Polytechnic University (other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT06515119 on ClinicalTrials.gov

What this trial studies

This pilot randomized control trial assesses the feasibility and acceptability of a newly developed resources-oriented intervention for individuals with pre-diabetes in China. The study aims to explore key components of the intervention, evaluate its preliminary efficacy on improving sense of coherence, coping strategies, perceived stress, health literacy, and HbA1c levels. It includes qualitative interviews to understand the experiences of coping with pre-diabetes and the utilization of available resources. The intervention is designed to empower participants to better manage their condition through a salutogenic approach.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old diagnosed with pre-diabetes and exhibiting low to moderate levels of sense of coherence.

Not a fit: Patients with a history of diabetes, serious health complications, or those currently participating in similar intervention programs may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could enhance coping strategies and overall health outcomes for patients with pre-diabetes.

How similar studies have performed: While salutogenesis-oriented interventions have been effective for diabetes, this specific approach for pre-diabetes is novel and has not been previously tested.

Eligibility criteria

Inclusion Criteria: Subjects are those with pre-diabetes and low or moderate level of sense of coherence.

1. prediabetes diagnosis: Pre-diabetes app score \>= 8, considered as 'pre-diabetes' or 'at high-risk of diabetes'; then, HbA1c test result within 5.7% to 6.4% will be diagnosed as prediabetes.
2. low or moderate SoC level: SoC-13 scale score \<= 74.
3. Chinese (Mandarin or Cantonese) or English and live in China,
4. could use Facebook and Zoom meeting app.

Exclusion Criteria:

Participants will be excluded if they:

1. have a history of diabetes, using hypoglycemic drugs, pregnancy, lactation, disability, or other physical limitations;
2. presence of serious health complications might affect the HbA1c level such as anemia, renal failure, liver disease;
3. participation in a similar intervention program within 3 months focusing on diabetes prevention in the past three months including educational workshops or courses, nutritional program, exercise program or mental health intervention.

Where this trial is running

Hong Kong

• The Hong Kong Polytechnic University — Hong Kong, Hong Kong (RECRUITING)

Study contacts

• Principal investigator: Angela Leung, PhD — The Hong Kong Polytechnic University
• Study coordinator: Angela Leung, PhD

Conditions: Sense of Coherence, Salutogenesis, PreDiabetes, sense of coherence, resources, prediabetes