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

Study Overview
=================
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.

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.

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.

Conditions
-----------------
Health Behavior, Physical Activity, Healthy Diet

Intervention / Treatment
-----------------
* Behavioral: Blended intervention group


Participation Criteria
=================
Eligibility Criteria
-----------------
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: no cognitive disorders or impairments; unable to engage in physical activity;

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blended Intervention Group<br>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<br>* 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.<br>|
| No Intervention: Control Group<br>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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Change from baseline to10 week follow-up | 
| Change of Agility and dynamic balance | 8 Foot Up-and-Go Test (second) | Change from baseline to10 week follow-up | 
| Change of Upper body flexibility | Back Scratch Test (upper body; +/- cm) | Change from baseline to10 week follow-up | 
| Change of Lower body flexibility | Chair Sit and Reach Test (lower body; +/- cm) | Change from baseline to10 week follow-up | 
| Change of Aerobic endurance | 2-Minute Step Test (times in two minutes) | Change from baseline to10 week follow-up | 
| Change of Upper body strength | 30-Second Arm Curl test (upper body; times per 30 seconds) | Change from baseline to10 week follow-up | 
| Change of Lower body strength | 30-Second Chair Stand test (lower body; times per 30 seconds); | Change from baseline to10 week follow-up | 
| Change of Body mass index (kg/m2) | Body mass index (kg/m2). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | baseline, 10 week follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eHealth intervention, health behavior change, face-to-face intervention, old adults