Resources-Oriented Salutogenic (ROS) Intervention for Pre-diabetes

NCT06515119 | Recruiting

• 1 other identifier: HSEARS20231206006
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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. 1.What are the key components (available resources and their utilization skills) of Resources-Oriented Salutogenic intervention in Chinese pre-diabetes population?
2. 2.What are the feasibility and acceptability of ROS intervention among pre-diabetes population in China?
3. 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?

Conditions

Sense of Coherence; Salutogenesis; PreDiabetes

Keywords

Salutogenesis; sense of coherence; resources; prediabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Diabetes risk

  Baseline; 8 weeks; 20 weeks

• Coping styles

  Baseline; 8 weeks; 20 weeks

• Perceived stress

  Baseline; 8 weeks; 20 weeks

• Diabetes literacy

  Baseline; 8 weeks; 20 weeks

• Health promotion behaviors

  Baseline; 8 weeks; 20 weeks

Study Arms (2)

Resources-oriented Salutogenic Intervention

EXPERIMENTAL

Intervention contents: Participants in the intervention group (IG) will receive online Resources-oriented Salutogenic intervention in the form of group lectures and in-session activity via Zoom meetings, and home activity via Facebook. Each group will have 7-8 participants. The intervention contents will provide information about resources and their utilization skills on health literacy related to prediabetes, healthy diet, exercise training, stress management, social support, and peer support. They will receive a) a resources booklet, b) "My Salutogenic Diary" for daily life recording, c) receive monthly telephone follow-ups. Intervention form: online group courses via Zoom meetings and Facebook. Intervention frequency and duration: 90 minutes per week, 8 weeks and two telephone follow-ups, once a month.

Behavioral: Resources-Oriented Salutogenic (ROS) intervention

Usual Care

NO INTERVENTION

The control group (CG) will receive usual care (that is, general health education about lifestyle) on Facebook and undergo monthly educational follow-ups via Facebook messages to check the practical application of healthy lifestyle.

Interventions

Resources-Oriented Salutogenic (ROS) intervention BEHAVIORAL

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.

Resources-oriented Salutogenic Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<= 74.
• Chinese (Mandarin or Cantonese) or English and live in China,
• could use Facebook and Zoom meeting app.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, 999077, Hong Kong

RECRUITING

Related Publications (9)

• Antonovsky, A. Health, stress, and coping: New perspectives on mental and physical well-being. San Francisco: 1979.

  BACKGROUND

• Eriksson M. The Sense of Coherence: The Concept and Its Relationship to Health. 2022 Jan 1. In: Mittelmark MB, Bauer GF, Vaandrager L, Pelikan JM, Sagy S, Eriksson M, Lindstrom B, Meier Magistretti C, editors. The Handbook of Salutogenesis [Internet]. 2nd edition. Cham (CH): Springer; 2022. Chapter 9. Available from http://www.ncbi.nlm.nih.gov/books/NBK584067/

  PMID: 36121981 BACKGROUND

• Eriksson M, Lindstrom B. Validity of Antonovsky's sense of coherence scale: a systematic review. J Epidemiol Community Health. 2005 Jun;59(6):460-6. doi: 10.1136/jech.2003.018085.

  PMID: 15911640 BACKGROUND

• Leung AY, Lou VW, Cheung MK, Chan SS, Chi I. Development and validation of Chinese Health Literacy Scale for Diabetes. J Clin Nurs. 2013 Aug;22(15-16):2090-9. doi: 10.1111/jocn.12018. Epub 2012 Nov 27.

  PMID: 23186320 BACKGROUND

• Leung AY, Xu XY, Chau PH, Yu YTE, Cheung MK, Wong CK, Fong DY, Wong JY, Lam CL. A Mobile App for Identifying Individuals With Undiagnosed Diabetes and Prediabetes and for Promoting Behavior Change: 2-Year Prospective Study. JMIR Mhealth Uhealth. 2018 May 24;6(5):e10662. doi: 10.2196/10662.

  PMID: 29793901 BACKGROUND

• Terry G, Hayfield N, Clarke V, et al. Thematic analysis. The SAGE handbook of qualitative research in psychology, 2017, 2(17-37): 25.

  BACKGROUND

• Xie, Y. Reliability and validity of the simplified Coping Style Questionnaire. Chinese Journal of Clinical Psychology, 1998; 6(2), 114-115.

  BACKGROUND

• Antonovsky A. Unraveling the mystery of health: How people manage stress and stay well. San Francisco. 1987;175.

  BACKGROUND

• Leung DY, Lam TH, Chan SS. Three versions of Perceived Stress Scale: validation in a sample of Chinese cardiac patients who smoke. BMC Public Health. 2010 Aug 25;10:513. doi: 10.1186/1471-2458-10-513.

  PMID: 20735860 BACKGROUND

MeSH Terms

Conditions

Prediabetic State

Interventions

Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Angela Leung, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Leung, PhD

CONTACT

+852 2766 5587; angela.ym.leung@polyu.edu.hk

Yaqian Liu, Msc

CONTACT

+852 4639 5744; yaqian.liu@connect.polyu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: July 23, 2024
• Study Start: March 20, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)