Health Support Project for Persons With Disabilities

NCT07346040 | Not Yet Recruiting DMC

• 1 other identifier: P0045968
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate the health status of people with disabilities, to improve their health outcomes by providing support on nutrition, physical activity, and self-management of chronic conditions, and to strengthen sectors' capacity to deliver health management services and support for people with disabilities through a train-the-trainer program.

Conditions

Disabilities

Keywords

People with disabilities; Chronic diseases; Nutrition; Physical activity; Self-management

Outcome Measures

Primary Outcomes (1)

• Comprehensive health literacy

  Comprehensive health literacy will be measured as general knowledge of nutrition, physical exercise, and self-management of chronic diseases using a self-designed, closed-ended questionnaire. Responses will be scored as follows: 1 point for the correct answer, and 0 points for the incorrect answer or for the "Not sure" response. The dichotomized scores for each item in each area will be summed, with results ranging from 0 to 30 for knowledge of nutrition, 0 to15 for knowledge of physical activity, and 0 to 27 for knowledge of self-management of chronic diseases. For participants with intellectual disabilities, the number of items will be reduced. The results will range from 0 to 21 for knowledge of nutrition, 0 to15 for knowledge of physical activity, and 0 to 27 for knowledge of self-management of chronic diseases. Higher scores indicate better health literacy regarding nutrition, physical exercise, and self-management of chronic diseases, separately.

  Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

Secondary Outcomes (11)

• Dietary intake

  Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

• Achievement of physical activity goals

  Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

• Self-efficacy for physical activity

  Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

• Body mass index (BMI)

  Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

• Blood pressure

  Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

Study Arms (2)

Control group

NO INTERVENTION

We will use a waiting-list control group. People with disabilities in the control group will receive care as usual at study sites, be free to seek any health services during the study period, and be invited to join the HSP program for 24 weeks after the study ends

Intervention group

EXPERIMENTAL

The intervention will last for 24 weeks.

Behavioral: Health Support Program

Interventions

Health Support Program BEHAVIORAL

The Health Support Program (HSP) is a structured, multi-component intervention. The nutrition component will consist of one 45-minute \[for those without intellectual disability (ID)\] or 30-minute \[for ID participants\] group-based healthy eating education session per week, led by registered dietitians. The physical activity component will consist of three 30-minute sessions per week led by registered physiotherapists, together with the encouragement of community exercise and walk every day. Self-management of chronic conditions component will be implemented weekly in a 45-minute \[for non-ID participants\] or 30-minute \[for ID participants\] education session in a group format, which will be led by occupational therapists and nurses. To accommodate cognitive deficits in participants with ID and maximize their learning outcomes, additional support will be provided in terms of the structure (e.g., interactive format) of the intervention.

Intervention group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• People with disabilities in sheltered workshops and integrated vocational rehabilitation services centers who had at least one of the following physician-diagnosed chronic conditions: diabetes, hypertension, hyperlipidaemia, cardiovascular disease, or obesity

You may not qualify if:

• Those with severe intellectual disabilities (IQ below 35) or at imminent risk of suicide

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Chronic Disease; Motor Activity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Jiali Dr. He, PhD

CONTACT

+852 95218090; stacy.he@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking strategies will be included.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 16, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 1 year after publication with no end date