Efficacy of the Resources-Oriented Salutogenic (ROS) Intervention on Sense of Coherence Among Pre-diabetes Population: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Sense of Coherence
研究概览
简要总结
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:
- What are the key components (available resources and their utilization skills) of Resources-Oriented Salutogenic intervention in Chinese pre-diabetes population?
- What are the feasibility and acceptability of ROS intervention among pre-diabetes population in China?
- 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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors who are uninvolved in other study phases will be unaware of group allocation. Participants will be advised not to disclose their group assignment to outcome assessors during the data collection.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are those with pre-diabetes and low or moderate level of sense of coherence.
- •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.
- •low or moderate SoC level: SoC-13 scale score <=
- •Chinese (Mandarin or Cantonese) or English and live in China,
- •could use Facebook and Zoom meeting app.
排除标准
- •Participants will be excluded if they:
- •have a history of diabetes, using hypoglycemic drugs, pregnancy, lactation, disability, or other physical limitations;
- •presence of serious health complications might affect the HbA1c level such as anemia, renal failure, liver disease;
- •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.
结局指标
主要结局
Sense of Coherence
时间窗: Baseline; 8 weeks; 20 weeks
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.
次要结局
- Diabetes risk(Baseline; 8 weeks; 20 weeks)
- Health promotion behaviors(Baseline; 8 weeks; 20 weeks)
- The glycated hemoglobin (HbA1c) test(Baseline; 20 weeks)
- Perceived stress(Baseline; 8 weeks; 20 weeks)
- Coping styles(Baseline; 8 weeks; 20 weeks)
- Diabetes literacy(Baseline; 8 weeks; 20 weeks)