NCT06515119

Resources-Oriented Salutogenic (ROS) 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Detailed description

Background: General advice on lifestyle modification is given to people with pre-diabetes, but low participation and limitation of education time and location is noted in diabetes prevention programs and low SoC level still exists among pre-diabetes population. Salutogenesis-oriented interventions are effective on people with diabetes but none of such interventions have been designed and applied to people with pre-diabetes in China. People with pre-diabetes has not been educated to identify and utilize their available resources to cope with their stressful and unhealthy condition (pre-diabetes). Objectives and methods: This study includes 3 phases: Phase 1: ROS intervention components exploration for Chinese Pre-diabetes population Objectives: to explore preferred available resources for improving SoC among Chinese Pre-diabetes population. Study design: A qualitative study. Individual in-depth semi-structured interviews guided by Salutogenic model will be conducted for approximately 40-60 min to explore the experience of coping with prediabetes, preferred General Resistance Resources (GRRs) and their utilizations after being diagnosed with prediabetes in Chinese pre-diabetes population. Method: Purposive sampling will be used to select targeted population. The targeted population will be included: adults above 18 years, who have been diagnosed with pre-diabetes by medical staff or by undergoing HbA1c testing (5.7-6.4%). Sample size will be determined by the principle of data saturation, that is when no new relevant information or themes are observed in the data. Phase 2: ROS intervention protocol development and refinement Objectives: 1. to confirm the proposed key components of ROS intervention to be in line with professionals' expectations; 2. to refine the ROS intervention protocol Study design: Content validity + qualitative study. Phase 2a: Six experts in diabetes prevention will be invited to assess the content validity of intervention protocol using a designed 10-item assessment form, aiming at achieving a satisfactory cut-off value of 0.83 in each item content validity index (i-CVI). Phase 2b: The semi-structured interviews with focus group (4 participants in each group) aim to evaluate the readability, acceptability, and feasibility of the intervention protocol among prediabetes population in Hong Kong. Method: For phase 2a, the inclusion criteria for experts will include: 1) have at least an expertise bachelor's degree; 2) have at least 3 years of working or research experience in their specialized area and be familiar with work in the field related to diabetes. Invitations will be extended via email, with a two-week response window for participation and form submission. For phase 2b, 12 prediabetes participants will be recruited from district health centers in Hong Kong. A doctoral student and a research assistant will conduct the 60-minute interview with participants via Zoom meeting to discuss words, sentences, or other specific contents with difficult to understand. All feedback from participants will help formulate the ROS intervention. The interview could be stopped until no new findings or information merged. Phase 3: Preliminary assessment in Pilot RCT Objectives: 1. to assess preliminary efficacy of ROS intervention on SoC, coping styles, perceived stress, health literacy, and HbA1c among prediabetes population in Hong Kong; 2. to explore their intervention experience. Study design: a pilot RCT + a qualitative study nested within the pilot trial Methods: For pilot RCT, 66 prediabetes participants will be randomized into the intervention group (IG) and control group (CG). Participants in IG will receive an online ROS course via Zoom meeting, post daily salutogenic recordings and comments on Facebook. While participants in CG will receive usual care (that is, general health education about lifestyle) in the Facebook and undergo monthly educational follow-ups via Facebook messages to check the practical application of healthy lifestyle. The primary outcome is SoC, and secondary outcomes include coping strategies, perceived stress, health literacy, and HbA1c, feasibility outcomes. For a nested qualitative study, 10 participants with extreme SoC level (low and high) will be purposely selected to participate in the semi-structured interview. The SoC level will be assessed by SoC-13 scale depending on the score differences between baseline and post-intervention tests. Data analysis: For qualitative data, a six-step inductive thematic analysis will be used in Phase 1, while content analysis will be used in Phase 2 and a nested qualitative study in Phase 3. For quantitative study, socio-demographic and feasibility data will be presented in absolute numbers and percentages for nominal (categorical) data, and Mean, and standard deviation for ratio (continuous) data or ordinal data. Homogeneity test for baseline will use Chi-square, Independent t-test, or Mann-Whitney U test. Generalized Estimating Equations will be used to analyze the efficacy differences in all primary and secondary outcomes.

Conditions

• Sense of Coherence
• Salutogenesis
• PreDiabetes

Interventions

Type	Name	Description
BEHAVIORAL	Resources-Oriented Salutogenic (ROS) intervention	Participants in intervention group will receive an online ROS course via Zoom meeting, post daily salutogenic recordings and comments on Facebook. A closed Facebook group will be created to deliver resources booklet, zoom meeting links, as well as encourage participants share their daily salutogenic recording, give comments and thumps-up by group members.

Timeline

• Start date: 2023-03-20
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2024-07-23
• Last updated: 2024-07-23

Locations

1 site across 1 country: Hong Kong