Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515119
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-09
Brief Title:
Resources-Oriented Salutogenic ROS Intervention for Pre-diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of the Resources-Oriented Salutogenic ROS Intervention on Sense of Coherence Among Pre-diabetes Population A Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROS
Brief 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
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 57-64 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 083 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 bachelors 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
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 57-64 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 083 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 bachelors 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None