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Clinical Trials/ChiCTR2400081193
ChiCTR2400081193
Not yet recruiting
Phase 1

Health Coaching with Physical Monitoring using Health Wearable (HCHW) to prevent noncommunicable diseases (NCDs) in the middle-aged: a 4-arms randomized controlled trial

Not provided4 sites in 1 countryStarted: March 1, 2024Last updated:
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Overview

Phase
Phase 1
Status
Not yet recruiting
Locations
4
Primary Endpoint
Blood biochemical (FBG, TC, HDL, LDL, TG)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The primary objectives of this RCT are to confirm:

  1. The effectiveness of health coaching (HC) + health watch (HW) intervention versus waitlist group on lipid profiles, glucose level, and blood pressures, and risk of having CVD (defined by QRisk)
  2. The effectiveness of the effect of HC-only intervention versus waitlist group and the effect of HW-only versus waitlist group on lipid, glucose, blood pressure, and risk of having CVD (defined by QRisk) The secondary objectives are exploratorily basis:
  3. The effectiveness of the interventions listed in the primary objectives on secondary outcomes (lifestyle measures such as physical activities, food consumption, and alcohol and smoking consumptions)
  4. To compare the effectiveness of combined interventions (HC + HW) versus HC-only and HW-only respectively.
  5. To compare the effectiveness of HC-only vs HW-only intervention.

Study Design

Study Type
干预性研究
Primary Purpose
随机平行对照
Masking
None

Eligibility Criteria

Ages
35 to 59 (—)
Sex
All

Inclusion Criteria

  • •Aged between 35 – 59.

Exclusion Criteria

  • •With doctor-diagnosed chronic diseases and require medication (including diabetes, hypertension, cardiovascular diseases, chronic obstructive pulmonary diseases, depression, autoimmune diseases, and cancer). 2) In the waiting list for follow-up healthcare services in the public or private sector because of the listed chronic diseases above. 3) A member of district health centre. 4) Those who cannot provide consent. 5) Pregnant woman. 6) Does not understand Cantonese.

Arms & Interventions

Health coaching + Smart watch intervention group

Health coaching intervention group

Smart watch intervention group

Waitlist control group

Outcomes

Primary Outcomes

Blood biochemical (FBG, TC, HDL, LDL, TG)

Time Frame: Baseline and 6 months

Blood pressure

Time Frame: Baseline and 6 months

Heart rate, Steps count, Frequency of Physical activity, Sleeping quality score

Time Frame: Baseline and 6 months

Secondary Outcomes

  • Alcohol use (by AUDIT-C)(Baseline and 6 months)
  • Diet(Baseline, 3 months and 6 months after intervention)
  • Physical activity level (by IPAQ-SF)(Baseline, 3 months and 6 months after intervention)
  • Health-related Quality of life (By EQ5D)(Baseline, 3 months and 6 months after intervention)
  • Sleep quality and disturbances (By PSQI)(Baseline, 3 months and 6 months after intervention)
  • Perceived stress (By PSS-10)(Baseline, 3 months and 6 months after intervention)
  • Anxiety (By GAD-7)(Baseline, 3 months and 6 months after intervention)
  • Depression (By PHQ-9)(Baseline, 3 months and 6 months after intervention)
  • Satisfactory of life(Baseline, 3 months and 6 months after intervention)
  • Social media addiction (BSMAS)(Baseline, 3 months and 6 months after intervention)
  • Loneliness (By 6-item De Jong Gierveld Loneliness Scale)(Baseline, 3 months and 6 months after intervention)
  • Self-efficacy (By 10-item General Self Efficacy Scale)(Baseline, 3 months and 6 months after intervention)
  • e-health literacy (By 8-item eHealth Literacy Scale)(Baseline, 3 months and 6 months after intervention)
  • Body composition(Baseline and 6 months)
  • Demographic and CVD risk exposure data(Baseline, 3 months and 6 months after intervention)

Investigators

Sponsor
Not provided

Study Sites (4)

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