Health BehaviorNCT05729087
Development of a Blended Lifestyle Intervention to Promote Physical Activity, Diet, and Health in Hong Kong Older Adults
A study testing Blended intervention group in people with Health Behavior and Physical Activity, run by Hong Kong Baptist University at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Physical Activity, Healthy Diet
- What is being tested?
- Blended intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Jun 2022to 22 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 79 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- no cognitive disorders or impairments;
- unable to engage in physical activity;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Acceptability, and Potential Effectiveness of a Web and Center-based Blended Lifestyle Intervention to Promote Physical Activity, Diet, and Health in Hong Kong Community-dwelling Older Adults: A Pilot Study.
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
- To review and meta-analyze lifestyle interventions for promotion of physical activity, diet and health among older adults.
- To assess the feasibility of the pilot study.
- To assess acceptability of the pilot study.
- 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.
- Conditions
- Health Behavior, Physical Activity, Healthy Diet
- Being tested
- Blended intervention group
- Keywords
- face-to-face intervention, eHealth intervention, health behavior change, old adults
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blended intervention groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to10 week follow-up
Secondary outcomes (18)
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.
Measured: Change from baseline to10 week follow-up
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.
Measured: Change from baseline to10 week follow-up
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.
Measured: Change from baseline to10 week follow-up
Change of Agility and dynamic balance
8 Foot Up-and-Go Test (second)
Measured: Change from baseline to10 week follow-up
Change of Upper body flexibility
Back Scratch Test (upper body; +/- cm)
Measured: Change from baseline to10 week follow-up
Change of Lower body flexibility
Chair Sit and Reach Test (lower body; +/- cm)
Measured: Change from baseline to10 week follow-up
Change of Aerobic endurance
2-Minute Step Test (times in two minutes)
Measured: Change from baseline to10 week follow-up
Change of Upper body strength
30-Second Arm Curl test (upper body; times per 30 seconds)
Measured: Change from baseline to10 week follow-up
Change of Lower body strength
30-Second Chair Stand test (lower body; times per 30 seconds);
Measured: Change from baseline to10 week follow-up
Change of Body mass index (kg/m2)
Body mass index (kg/m2).
Measured: Change from baseline to10 week follow-up
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.
Measured: Change from baseline to10 week follow-up
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.
Measured: Change from baseline to10 week follow-up
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.
Measured: Change from baseline to10 week follow-up
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.
Measured: Change from baseline to10 week follow-up
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.
Measured: baseline, 10 week follow-up
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.
Measured: Change from baseline to10 week follow-up
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.
Measured: Change from baseline to10 week follow-up
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.
Measured: baseline, 10 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start14 Jun 2022
- Primary completion19 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanping DUAN, Hong Kong Baptist University
- Investigators
- Yanping Duan, Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729087
- Sponsor's protocol ID
- REC/21-22/0485
- Status last verified
- Feb 2023
- First submitted
- 15 Nov 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Potential Effectiveness of a Web and Center-based Blended Lifestyle Intervention to Promote Physical Activity, Diet, and Health in Hong Kong Community-dwelling Older Adults: A Pilot Study.
- ClinicalTrials.gov ID
- NCT05729087
- Acronym / sponsor ID
- REC/21-22/0485
- Conditions
- Health Behavior, Physical Activity, Healthy Diet
- Keywords
- face-to-face intervention, eHealth intervention, health behavior change, old adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Project Objectives
- To review and meta-analyze lifestyle interventions for promotion of physical activity, diet and health among older adults.
- To assess the feasibility of the pilot study.
- To assess acceptability of the pilot study.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blended Intervention Group | Experimental | Behavioral: Blended intervention groupA 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. |
| 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. |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- no cognitive disorders or impairments;
- unable to engage in physical activity;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blended intervention groupFace-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. | Behavioural | Blended Intervention Group |
Primary outcome
Change of weekly Physical activity (minutes per week)
Time frame: Change from baseline to10 week follow-up
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 of Fruit and Vegetable Intake (portions/day)
Time frame: Change from baseline to10 week follow-up
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 of Meat, Fish, Egg & Alternatives (MFEA) (taels/day)
Time frame: Change from baseline to10 week follow-up
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.
18 secondary outcomes
Change of Blood pressure (mmHg)
Time frame: Change from baseline to10 week follow-up
Change of the Glycosylated Hemoglobin (HbA1c; %)
Time frame: Change from baseline to10 week follow-up
Change of the lipid (mmol/L)
Time frame: Change from baseline to10 week follow-up
Change of Agility and dynamic balance
Time frame: Change from baseline to10 week follow-up
Change of Upper body flexibility
Time frame: Change from baseline to10 week follow-up
Change of Lower body flexibility
Time frame: Change from baseline to10 week follow-up
Change of Aerobic endurance
Time frame: Change from baseline to10 week follow-up
Change of Upper body strength
Time frame: Change from baseline to10 week follow-up
Change of Lower body strength
Time frame: Change from baseline to10 week follow-up
Change of Body mass index (kg/m2)
Time frame: Change from baseline to10 week follow-up
Change of Health-Related Quality of life (HRQoL)
Time frame: Change from baseline to10 week follow-up
Change of Depression level (score)
Time frame: Change from baseline to10 week follow-up
Change of Loneliness (score)
Time frame: Change from baseline to10 week follow-up
Change of Self-efficacy of PA and diet
Time frame: Change from baseline to10 week follow-up
Action control of PA and diet
Time frame: baseline, 10 week follow-up
Change of Planning of PA and diet
Time frame: Change from baseline to10 week follow-up
Change of Social support of PA and diet
Time frame: Change from baseline to10 week follow-up
Demographic information
Time frame: baseline, 10 week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanping Duan principal investigator
Hong Kong Baptist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blended intervention group in people with Health Behavior and Physical Activity, run by Hong Kong Baptist University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of weekly Physical activity (minutes per week) (time frame: Change from baseline to10 week follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.