Clinical trial NCT06515119: Resources-Oriented Salutogenic (ROS) Intervention for Pre-diabetes
Official title: Efficacy of the Resources-Oriented Salutogenic (ROS) Intervention on Sense of Coherence Among Pre-diabetes Population: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sense of Coherence
Salutogenesis
PreDiabetes
Keywords: Salutogenesis
sense of coherence
resources
prediabetes
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 66 prediabetes participants will be randomized into the intervention group and control group. Randomization will be conducted using the Research Randomizer Software and performed by a research team member who will not contact participants. Allocation will be concealed in sealed envelopes and revealed until trials commence, that is, after participants' submission of consent forms and completion of baseline assessments.
Primary purpose: PREVENTION

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?

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.

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.

Primary outcomes:
measure: Sense of Coherence
timeFrame: Baseline; 8 weeks; 20 weeks
Secondary outcomes:
measure: Diabetes risk
timeFrame: Baseline; 8 weeks; 20 weeks
measure: Coping styles
timeFrame: Baseline; 8 weeks; 20 weeks
measure: Perceived stress
timeFrame: Baseline; 8 weeks; 20 weeks
measure: Diabetes literacy
timeFrame: Baseline; 8 weeks; 20 weeks
measure: Health promotion behaviors
timeFrame: Baseline; 8 weeks; 20 weeks
measure: The glycated hemoglobin (HbA1c) test
timeFrame: Baseline; 20 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Angela Leung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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