ClinicalTrials.gg
CompletedNCT05729087Updated Feb 15, 2023

Development of a Blended Lifestyle Intervention to Promote Physical Activity, Diet, and Health in Hong Kong Older Adults

An interventional study of Blended intervention group in Health Behavior, Physical Activity and Healthy Diet, sponsored by Hong Kong Baptist University. Completed at 1 site in Hong Kong. Open to participants aged 65 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-15.

Sponsored by Hong Kong Baptist University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jun 2022, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
65 Years to 79 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies in Health Behavior with a site in Hong Kong — none open to participants now, none under way, none of them phase 3. Health Behavior · Hong Kong.

Enrollment
13th of 14
80 · median 434
Started
2022
the only one that year
No phase
14 of 14
none open now
Registered
12th of 14
by date
Lead sponsor
2 of 14
Hong Kong Baptist University

Among the 14 studies in Health Behavior with a site in Hong Kong, this one is the 13th largest by enrollment, is the only one that started in 2022, is one of 14 with no phase, and was the 12th registered.

Health Behavior

967 studies on the registry are indexed under Health Behavior; 165 are open to participants now.

Browse Health Behavior studies →

Open to participants now

None of the 14 studies in Health Behavior with a site in Hong Kong is open now.

Who these studies take

Of the 93 Health Behavior studies recruiting now, 39 (42%) set no upper age limit and 37 (40%) stop at 75 or younger; 25 take children under 18; 58 take healthy volunteers.

This study: 65 Years to 79 Years · all sexes · healthy volunteers too.

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Download CSVNarrow it in search →With an account: the 14 studies in Health Behavior with a site in Hong Kong as a file.
02

Study 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.

Read the detailed description

Project Objectives

  1. To review and meta-analyze lifestyle interventions for promotion of physical activity, diet and health among older adults.
  2. To assess the feasibility of the pilot study.
  3. To assess acceptability of the pilot study.
  4. To examine between-group differences in changes of physical activity (min/week), diet (portion/day), physical health-related outcomes (physical fitness, blood pressure, fasting blood sugar, and blood lipids), mental health-related outcomes (depression, loneliness) and health-related quality of life (QoL) among the sample.

A series of generalized linear mixed models (GLMM) will be applied to evaluate the intervention effects on outcome measures at T2, with time, groups, and their interaction as fixed effects. Per-protocol analyses will be used for primary analyses, while intention-to-treat approach will be used for sensitivity tests.

03

Conditions studied

  • Health Behavior
  • Physical Activity
  • Healthy Diet

Keywords

  • face-to-face intervention
  • eHealth intervention
  • health behavior change
  • old adults
04

Who can participate

Ages eligible
65 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • no cognitive disorders or impairments;
  • unable to engage in physical activity;
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Blended Intervention Group

    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

  • No intervention
    Control Group

    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

  • BehavioralBlended intervention group

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline to10 week follow-up

  2. 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.

    Time frame: Change from baseline to10 week follow-up

  3. 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.

    Time frame: Change from baseline to10 week follow-up

Secondary outcomes

  1. Change of Blood pressure (mmHg)

    The Blood pressure will be measured by an automated portable device . If there is a change, and the follow-up result is below 120, the result is better.

    Time frame: Change from baseline to10 week follow-up

  2. Change of the Glycosylated Hemoglobin (HbA1c; %)

    The Glycosylated Hemoglobin (HbA1c) will be tested by the Point of Care Cobas b 101 system. If there is a change, and the follow-up result is below 6.5, the result is better.

    Time frame: Change from baseline to10 week follow-up

  3. Change of the lipid (mmol/L)

    The lipid, including total cholesterol (CHOL; mmol/L), triglycerides (TG; mmol/L); high-density lipoprotein (HDL; mmol/L); and low-density lipoprotein (LDL; mmol/L)will be tested by Point of Care (POC) Cobas b 101 system.

    Time frame: Change from baseline to10 week follow-up

  4. Change of Agility and dynamic balance

    8 Foot Up-and-Go Test (second)

    Time frame: Change from baseline to10 week follow-up

  5. Change of Upper body flexibility

    Back Scratch Test (upper body; +/- cm)

    Time frame: Change from baseline to10 week follow-up

  6. Change of Lower body flexibility

    Chair Sit and Reach Test (lower body; +/- cm)

    Time frame: Change from baseline to10 week follow-up

  7. Change of Aerobic endurance

    2-Minute Step Test (times in two minutes)

    Time frame: Change from baseline to10 week follow-up

  8. Change of Upper body strength

    30-Second Arm Curl test (upper body; times per 30 seconds)

    Time frame: Change from baseline to10 week follow-up

  9. Change of Lower body strength

    30-Second Chair Stand test (lower body; times per 30 seconds);

    Time frame: Change from baseline to10 week follow-up

  10. Change of Body mass index (kg/m2)

    Body mass index (kg/m2).

    Time frame: Change from baseline to10 week follow-up

  11. Change of Health-Related Quality of life (HRQoL)

    The Hong Kong brief version of the World Health Organization's Quality of Life questionnaire. We measured general quality of life with the question "How would you rate your quality of life?" with a 5-point scale (1=very poor; 5=very good). We also used the physical health subdomain with 7 items, such as "How satisfied are you with your ability to perform your daily living activities?" (1=very dissatisfied; 5=very satisfied). If there is an increase, the result means a better outcome.

    Time frame: Change from baseline to10 week follow-up

  12. Change of Depression level (score)

    Geriatric Depression Scale 15-item - Cantonese Version. Participants were asked to indicate the frequency of symptoms on a yes/no questionnaire (yes=1; no=0; except items 1,5,7,9,11: yes=0; no=1) within the last week. Positively formulated items were reversed. The total score consisted of the sum of all 15 items and ranged from 0 to 15. A total score of 5 or greater indicated the likelihood of depression symptoms. If there is an increase, the result means a worse outcome.

    Time frame: Change from baseline to10 week follow-up

  13. Change of Loneliness (score)

    The Chinese translation of the 6-item De Jong Gierveld Loneliness Scale. The emotional loneliness was measured by 3 items (yes=1, moderate=1, no=0), such as "I experience a general sense of emptiness". Social loneliness was measured by 3 items (yes=0, moderate=1, no=1). A total score of 2 or greater indicated the likelihood of loneliness. If there is an increase, the result means a better outcome.

    Time frame: Change from baseline to10 week follow-up

  14. Change of Self-efficacy of PA and diet

    We assessed self-efficacy for PA with 5 items on a 5-point scale (1=don't agree at all; 5=totally agree), such as "I am certain that I can permanently be physically active for at least 5 days a week for 30 minutes each day". We assessed self-efficacy for fruit and vegetable by 5 items on the basis of the PA scale, such as "I am certain that I can eat 5 portions of fruit and vegetables a day even if it is sometimes difficult". We assessed self-efficacy for MFEA by 5 items on the basis of the PA scale, such as "I am certain that I can eat moderate MFEA a day even if it is sometimes difficult". If there is an increase, the result means a better outcome.

    Time frame: Change from baseline to10 week follow-up

  15. Action control of PA and diet

    We assessed action control for PA with 6 items on a 5-point scale (1=don't agree at all; 5=totally agree), such as "I consistently monitored when, where, and how long I exercise". We assessed action control for FVI/MFEA with 6 items separately on a 5-point scale (1=don't agree at all; 5=totally agree), such as "I consistently monitored whether I ate enough fruit and vegetable /moderate meat". If there is an increase, the result means a better outcome.

    Time frame: baseline, 10 week follow-up

  16. Change of Planning of PA and diet

    We distinguished planning as action planning and coping planning. We assessed action planning by the stem "For the next month I have carefully planned..." followed by 3 items for PA, such as "which PA I will pursue," and followed by 1 item for FVI and 1 item for MFEA, such as "what I will eat". We assessed coping planning by the stem "For the next month I have carefully planned..." followed by 3 items for PA, such as "what I can do in difficult situations to stick to my intentions," or followed by 3 items for FVI and 3 items for MFEA, such as "how I can eat healthy, even if something happened" . Answers were given on a 5-point scale ranging from 1=totally disagree to 5=totally agree. If there is an increase, the result means a better outcome.

    Time frame: Change from baseline to10 week follow-up

  17. Change of Social support of PA and diet

    We assessed social support with 3 items for PA and with 3 items for FVI and 3 items for MFEA, such as "My partner helps me/my family helps me/my classmates and friends help me to stay physically active," or "My partner helps me/my family helps me/my classmates and friends help me to eat healthily." Answers were measured with a 5-point scale (1=not at all true; 5=exactly true). If there is an increase, the result means a better outcome.

    Time frame: Change from baseline to10 week follow-up

  18. Demographic information

    Items will include gender, year of birth, marital status, educational level, household income, professional status, living status, number of children, and history of chronic diseases.

    Time frame: baseline, 10 week follow-up

07

Study locations

1 site
  • Hong Kong Baptist University
    Kowloon Tong, Hong Kong
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2022 to primary completion in Aug 2022, 2 months.

Of 567 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's 2 months is below that.

Counting every sponsor, half of 585 studies reached it within 15 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2022
First posted
Feb 15, 2023
StartActual
Jun 14, 2022
Primary completionActual
Aug 19, 2022
CompletionActual
Aug 22, 2022
Last update
Feb 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05729087
Lead sponsor
Hong Kong Baptist University
Responsible party
Yanping DUAN (Dr. Yanping Duan, Hong Kong Baptist University) — Principal investigator
First posted
Feb 15, 2023
Start date
Jun 14, 2022
Primary completion
Aug 19, 2022
Completion
Aug 22, 2022
Last update
Feb 15, 2023

Study contacts

Yanping Duan
principal investigator · Hong Kong Baptist University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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