Resources-Oriented Salutogenic (ROS) Intervention for Pre-diabetes
NCT Number: NCT06515119
Acronym: ROS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sense of Coherence|Salutogenesis|PreDiabetes
Interventions: BEHAVIORAL: Resources-Oriented Salutogenic (ROS) intervention
Sponsor: The Hong Kong Polytechnic University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2023-03-20
Completion Date: 2025-08-31
Locations: The Hong Kong Polytechnic University, Hong Kong, 999077, Hong Kong

Summary:
This pilot randomized control trial (RCT) is to assess whether the newly developed resources-oriented intervention is feasible and acceptable to people with pre-diabetes and has preliminary efficacy on sense of coherence (SoC).

The research questions are:

1. What are the key components (available resources and their utilization skills) of Resources-Oriented Salutogenic intervention in Chinese pre-diabetes population?
2. What are the feasibility and acceptability of ROS intervention among pre-diabetes population in China?
3. What is the preliminary efficacy of ROS intervention on improving sense of coherence, coping strategies, perceived stress, health literacy, and HbA1c on Chinese pre-diabetes population?

Primary Outcome Measures: Sense of Coherence, SoC level of pre-diabetes population will be measured by 13-item Sense of Coherence Scale (SoC-13). It includes consists of 13 items in three domains: comprehensibility (item: 2,6,8,9,11), manageability (item: 3,5,10,13), and meaningfulness (item: 1,4,7,12). The 7-point Likert scale was used along with five reverse scoring items (item: 1,2,3,7,10). Higher scores indicate a higher level of SoC; a low level of SoC corresponded to SoC scores of 13-57, medium level referred to 58-74, and high SoC was 75-91., Baseline; 8 weeks; 20 weeks
Secondary Outcome Measures: Diabetes risk, The pre-diabetes App is a convenient, non-invasive and straightforward tool for measuring diabetes risk. It includes the Chinese version of Finnish Diabetes Risk Score (FINDRISC) as well as the questions related to potential factors of diabetes like diabetes history, smoking, drinking, dietary pattern and physical activity engagement. The overall scores range from 0 to 26. The score of pre-diabetes app is greater than 8 in Chinese population indicating high-risk of diabetes., Baseline; 8 weeks; 20 weeks|Coping styles, The Simplified Copying Style Questionnaire (SCSQ) will be used to measure the pre-diabetes population's coping styles after diagnosed with high-risk of diabetes.This scale consisted of 20 items and two subscales: positive (12 items) and negative coping style (8 items), with a 4-point Likert scale from 0 (never) to 3 (frequently). Higher scores in subscales indicated that the respondents are to adopt positive or negative coping styles., Baseline; 8 weeks; 20 weeks|Perceived stress, The Perceived Stress Scale (PSS) will be used to measure the perception of stress in pre-diabetes population. The PSS-10 is a 10-item instrument with negative aspect (items 1,2,3,6,9,10) and positive aspect (items 4,5,7,8). This scale used a five-point Likert scale with scores ranging from 0 (never) to 4 (very often), with total scores from 0 to 20. Higher scores indicate higher perceived stress., Baseline; 8 weeks; 20 weeks|Diabetes literacy, The Chinese Health Literacy Scale for diabetes (CHLSD) will be used to measure the level of health literacy related to prediabetes. This scale consisted of 34 items and four sub-scales: remembering (18 items), understanding (7 items), applying (5 items) , analyzing (4 items). Two scores are given to the correct answer of each item. The CHLSD ranged from 0 to 68, with the total scores less than 48 indicating inadequate health literacy; the higher scores indicate the better health literacy. The Cronbach's alpha of four sub-scales in Chinese population is from 0.65 to 0.88., Baseline; 8 weeks; 20 weeks|Health promotion behaviors, The health promotion lifestyle profile-II (HPLP-II) will be used to measure health promotion behaviours of pre-diabetes population. A total of 52 items were measured using four-point Likert scale, with total score ranging from 52 to 208. The higher scores indicate better engagement in health-promoting behaviours. The total scores of low, moderate, high level correspond 52-104, 205-156, 157-208, respectively., Baseline; 8 weeks; 20 weeks|The glycated hemoglobin (HbA1c) test, A portable HbAc1 test system by point-of-care testing (Cobas b101 system) will be used to measure HbAc1 levels., Baseline; 20 weeks