NCT05729087

Brief Summary

This pilot study will provide a theory-based low-cost and easy-to-operate program in the area of healthy lifestyle promotion among community dwelling older adults. The blended intervention product will be helpful for health professionals, social workers and practitioners working in the elderly centers and health centers to promote older adults' PA, healthy diet and wellness. Furthermore, this study would initiate advocacy for policymakers to disseminate cost-saving, time-efficient and effective healthy lifestyle programs to the communities for healthy aging promotion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

November 15, 2022

Last Update Submit

February 6, 2023

Conditions

Keywords

face-to-face interventioneHealth interventionhealth behavior changeold adults

Outcome Measures

Primary Outcomes (3)

  • Change of weekly Physical activity (minutes per week)

    Walking; moderate physical activity; vigorous physical activity The waist-worn accelerometer will be used to objectively assess PA (GT3X+, ActiGraph Inc, Pensacola, FL, USA). The Chinese version of the International Physical Activity Questionnaire-short form (IPAQ-C). If there is an increase, the result means a better outcome.

    Change from baseline to10 week follow-up

  • Change of Fruit and Vegetable Intake (portions/day)

    To assess the fruit and vegetable intake during the past seven days, participants will be asked "how many portions of fruit they have today" and "how many portions of vegetables they have today". Participants were asked to keep a record for seven days, then to get an average for each day. If there is an increase, the result means a better outcome.

    Change from baseline to10 week follow-up

  • Change of Meat, Fish, Egg & Alternatives (MFEA) (taels/day)

    To assess the Meat, Fish, Egg \& Alternatives consumption, individuals will be asked to answer three items. To assess the Meat, Fish, Egg \& Alternatives during the past seven days, participants will be asked "how many taels of meat do they have today", "how many taels of eggs do they have today" and "how many taels of Alternatives do they have today". Participants were asked to keep a record for seven days, then to get an average intake of Meat, Fish, Egg \& Alternatives for each day. If there is a change, and the follow-up result is between 5 and 6, the result is better.

    Change from baseline to10 week follow-up

Secondary Outcomes (18)

  • Change of Blood pressure (mmHg)

    Change from baseline to10 week follow-up

  • Change of the Glycosylated Hemoglobin (HbA1c; %)

    Change from baseline to10 week follow-up

  • Change of the lipid (mmol/L)

    Change from baseline to10 week follow-up

  • Change of Agility and dynamic balance

    Change from baseline to10 week follow-up

  • Change of Upper body flexibility

    Change from baseline to10 week follow-up

  • +13 more secondary outcomes

Study Arms (2)

Blended Intervention Group

EXPERIMENTAL

A 10-week lifestyle intervention will be provided, addressing physical activity (PA) and healthy diet simultaneously. The program mode is a web- and center-based blended intervention. The web-based lifestyle behavior intervention will be developed based on the Health Action Process Approach.

Behavioral: Blended intervention group

Control Group

NO INTERVENTION

No treatment will be provided during the intervention period. Relevant intervention materials are accessible and available for all participants in the control group after the completion of data collection.

Interventions

Face-to-face workshops will be delivered in the neighborhood elderly center every week. Each workshop will consist of two sections (a) a 60-minute PA session, including a Health talk (20 minutes), and a physical exercise training (40 minutes); and (b) a 60-minute healthy diet promotion, including group discussion and sharing (30 minutes), and knowledge of diet and nutrition (30 minutes). In addition, a 15-minute online psychological session will be implemented following the PA and diet session.

Blended Intervention Group

Eligibility Criteria

Age65 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • aged 65-79 years;
  • have access to the internet and smartphone;
  • speak Cantonese;
  • pass the Physical Activity Readiness-Questionnaire (PAR-Q) screening or have the physician's approval prior to participation.

You may not qualify if:

  • no cognitive disorders or impairments;
  • unable to engage in physical activity;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Baptist University

Kowloon Tong, Hong Kong

Location

MeSH Terms

Conditions

Health BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Yanping Duan

    Hong Kong Baptist University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Yanping Duan

Study Record Dates

First Submitted

November 15, 2022

First Posted

February 15, 2023

Study Start

June 14, 2022

Primary Completion

August 19, 2022

Study Completion

August 22, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations