Mild Cognitive ImpairmentNCT06572748
Evaluation Study for the Chef Anchor 3.0 Program
A study testing 10-week programme in people with Mild Cognitive Impairment and Dementia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Objectives: 1. (Primary)To estimate the potential effects of the cooking program on the people with MCI/dementia and their informal caregivers; 2. To investigate if the potential effects can be maintained after the completion of the program. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Dementia
- What is being tested?
- 10-week programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60 or above;
- Diagnosed by medical doctor has having MCI/dementia as reported by the older adults or their informal caregivers, or with reported subjective decline of cognitive function and with 5-min MoCA score ≤7th age- and education-specific percentile (Wong et al., 2015);
- Ability to follow simple instructions;
- Adequate physical strength to attend cooking workshops.
Who cannot join
- Without caregiver
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Elderly community centre
Hong Kong
Pui Hing Chau, 3917 6626, phpchau@hku.hk
About this study
Official title: Evaluation Study for the Chef Anchor 3.0 Program for Older People With Mild Cognitive Impairment/Dementia and Their Informal Caregivers
Objectives:
- (Primary)To estimate the potential effects of the cooking program on the people with MCI/dementia and their informal caregivers;
- To investigate if the potential effects can be maintained after the completion of the program.
Read more
Study design and participants:
A convenience sample of 68 pair older adults with MCI/dementia and their informal caregivers from the Chef Anchor 3.0 Programme will be referred to the research team. Overall, participants will be assigned to intervention group and waitlist control group in a ratio of 1:1. Allocation will take into account the participants' availability and the programme capacity. Assessors of outcomes and data analyst will be blinded throughout the whole study.
During the first 10 weeks, the intervention group will undergo the 10-week programme in the "Chef Anchor 3.0", while no activity for the waitlist control group. Then, from week 10 to 20, the waitlist control group will attend the same 10-week programme.
Measurements:
Main outcome measures for people with MCI/dementia will include confidence in cooking (Primary), cooking capability, satisfaction with autonomy in cooking, Satisfaction with meal choices, Worried about future cooking ability and meal choices, cognitive function, self-reported appetite, psychological well-being, family harmony and satisfaction, as well as self-rated health.
Outcome measures for informal caregivers will include confidence in care recipient' s cooking, worried about future cooking ability and meal choices of care recipient, caregiver burden, psychological well-being, family harmony and satisfaction, as well as self-rated health.
Other measures will include attendance rate, home practice rate, drop-out rate, programme satisfaction, and recommendation to others.
Hypotheses
- The confidence in cooking, cooking capability, satisfaction with autonomy in cooking, satisfaction with meal choices, worried about future cooking ability and meal choices, cognitive function, self-reported appetite, psychological well-being, family satisfaction, and self-rated health of older adults with MCI/dementia would improve after the programme;
- The confidence in care recipient's cooking, worried about future cooking ability and meal choices of care recipient, psychological well-being, family satisfaction, caregiver burden, and self-rated health of informal caregivers would improve after the programme;
- The 10-week programme is acceptable for the most of older adults with MCI/dementia and their informal caregivers.
- Conditions
- Mild Cognitive Impairment, Dementia
- Being tested
- 10-week programme
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-week programmeOther
- 2-week health education (4 sessions, 60 minutes per session) Social workers and occupational therapists will explain the cognitive training elements of the program and introduce the "DementiAbility Methods" to the participants. Nutritionist, speech therapists, and Chinese medicine practitioner will share insights from their perspectives to enhance participants' understanding of cognitive impairments.
- 8-week cooking class (5 sessions, 120 minutes per session) The culinary instructor will teach participants to cook homemade dishes while integrating "procedural memory" into recipes. Older adults and their caregivers will cook together based on the "procedural recipe" designed by caregivers, aiming to enhance communication between them and create joyful memories. The cooking class will begin with 20-30 minutes an interactive nutrition-based session. The session themes will focus on healthy diet and food safety. Participants will be able to ask questions and make comments.
| Study group | Role | What they receive |
|---|---|---|
| Assigned intervention | Other | During the first 10 weeks, the intervention group will undergo the 10-week programme in the "Chef Anchor 3.0" Receives: Other: 10-week programme |
| Assigned waitlist attention control | Other | During the first 10 weeks, no activity for the waitlist control group. Then, from week 10 to 20, the waitlist control group will attend the same 10-week programme. Receives: Other: 10-week programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline confidence in cooking of people with MCI/dementia at 10 weeks
measured by a single question asking to what extent (1 to 10) the participant feels confident with cooking a meal. Score 1 refers to no confidence and score 10 refers to very confident. Ten smileys will be used to visualize the different extent. This outcome is the primary outcome.
Measured: 10 weeks after baseline
Change from baseline confidence in cooking of people with MCI/dementia at 20 weeks
measured by a single question asking to what extent (1 to 10) the participant feels confident with cooking a meal. Score 1 refers to no confidence and score 10 refers to very confident. Ten smileys will be used to visualize the different extent. This outcome is the primary outcome.
Measured: 20 weeks after baseline
Change from baseline confidence in cooking of people with MCI/dementia at 30 weeks
measured by a single question asking to what extent (1 to 10) the participant feels confident with cooking a meal. Score 1 refers to no confidence and score 10 refers to very confident. Ten smileys will be used to visualize the different extent. This outcome is the primary outcome.
Measured: 30 weeks after baseline, only for waitlist control group
Secondary outcomes (68)
Change from baseline cooking capability of people with MCI/dementia at 10 weeks
measured by a single question asking how much assistance from others the participant is needed when cooking. Score 0 refers to never cook, score 1 refers to being able to cook independently, score 2 refers to sometimes or part of the process requires help from others or requiring special assistive equipment/devices, and score 3 refers to being dependent on help from others or unable to complete this activity due to health condition.
Measured: 10 weeks after baseline
Change from baseline cooking capability of people with MCI/dementia at 20 weeks
measured by a single question asking how much assistance from others the participant is needed when cooking. Score 0 refers to never cook, score 1 refers to being able to cook independently, score 2 refers to sometimes or part of the process requires help from others or requiring special assistive equipment/devices, and score 3 refers to being dependent on help from others or unable to complete this activity due to health condition
Measured: 20 weeks after baseline
Change from baseline cooking capability of people with MCI/dementia at 30 weeks
measured by a single question asking how much assistance from others the participant is needed when cooking. Score 0 refers to never cook, score 1 refers to being able to cook independently, score 2 refers to sometimes or part of the process requires help from others or requiring special assistive equipment/devices, and score 3 refers to being dependent on help from others or unable to complete this activity due to health condition.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline satisfaction with autonomy in cooking of people with MCI/dementia at 10 weeks
measured by a single question asking to what extent (1 to 10) the participant is satisfied with the ability to cook a meal autonomously. Score 1 refers to not satisfactory at all and score 10 refers to very satisfactory. Ten smileys will be used to visualize the different extent.
Measured: 10 weeks after baseline
Change from baseline satisfaction with autonomy in cooking of people with MCI/dementia at 20 weeks
measured by a single question asking to what extent (1 to 10) the participant is satisfied with the ability to cook a meal autonomously. Score 1 refers to not satisfactory at all and score 10 refers to very satisfactory. Ten smileys will be used to visualize the different extent.
Measured: 20 weeks after baseline
Change from baseline satisfaction with autonomy in cooking of people with MCI/dementia at 30 weeks
measured by a single question asking to what extent (1 to 10) the participant is satisfied with the ability to cook a meal autonomously. Score 1 refers to not satisfactory at all and score 10 refers to very satisfactory. Ten smileys will be used to visualize the different extent.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline satisfaction with meal choices of people with MCI/dementia at 10 weeks
measured by two questions asking to what extent (1 to 10) the participant is satisfied with the choice of ingredients and cooking methods, respectively. Score 1 refers to not satisfactory at all and score 10 refers to very satisfactory. Ten smileys will be used to visualize the different extent.
Measured: 10 weeks after baseline
Change from baseline satisfaction with meal choices of people with MCI/dementia at 20 weeks
measured by two questions asking to what extent (1 to 10) the participant is satisfied with the choice of ingredients and cooking methods, respectively. Score 1 refers to not satisfactory at all and score 10 refers to very satisfactory. Ten smileys will be used to visualize the different extent.
Measured: 20 weeks after baseline
Change from baseline satisfaction with meal choices of people with MCI/dementia at 30 weeks
measured by two questions asking to what extent (1 to 10) the participant is satisfied with the choice of ingredients and cooking methods, respectively. Score 1 refers to not satisfactory at all and score 10 refers to very satisfactory. Ten smileys will be used to visualize the different extent.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline worried about future cooking ability and meal choices of people with MCI/dementia at 10 weeks
measured by three questions to what extent (1 to 10) the participant is worried about with the future cooking ability, choice of ingredients and cooking methods, respectively. Score 1 refers to completely worried and score 10 refers to not worried at all. Ten smileys will be used to visualize the different extent.
Measured: 10 weeks after baseline
Change from baseline worried about future cooking ability and meal choices of people with MCI/dementia at 20 weeks
measured by three questions to what extent (1 to 10) the participant is worried about with the future cooking ability, choice of ingredients and cooking methods, respectively. Score 1 refers to completely worried and score 10 refers to not worried at all. Ten smileys will be used to visualize the different extent.
Measured: 20 weeks after baseline
Change from baseline worried about future cooking ability and meal choices of people with MCI/dementia at 30 weeks
measured by three questions to what extent (1 to 10) the participant is worried about with the future cooking ability, choice of ingredients and cooking methods, respectively. Score 1 refers to completely worried and score 10 refers to not worried at all. Ten smileys will be used to visualize the different extent.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline cognitive function of people with MCI/dementia at 10 weeks
measured by the Chinese version of 5-min Montreal Cognitive Assessment (MoCA) (Feng et al., 2021; A. Wong et al., 2015). The assessment comprises four parts, including memory, language fluency, orientation, and delayed recall. The total score ranged between 0 to 30, and is obtained by summing the sub-scores from each part, with a higher score indicating better cognitive function. To determine the cognitive performance of participants, their scores will be compared to their age- and education-specific standards.
Measured: 10 weeks after baseline
Change from baseline cognitive function of people with MCI/dementia at 20 weeks
measured by the Chinese version of 5-min Montreal Cognitive Assessment (MoCA) (Feng et al., 2021; A. Wong et al., 2015). The assessment comprises four parts, including memory, language fluency, orientation, and delayed recall. The total score ranged between 0 to 30, and is obtained by summing the sub-scores from each part, with a higher score indicating better cognitive function. To determine the cognitive performance of participants, their scores will be compared to their age- and education-specific standards.
Measured: 20 weeks after baseline
Change from baseline cognitive function of people with MCI/dementia at 30 weeks
measured by the Chinese version of 5-min Montreal Cognitive Assessment (MoCA) (Feng et al., 2021; A. Wong et al., 2015). The assessment comprises four parts, including memory, language fluency, orientation, and delayed recall. The total score ranged between 0 to 30, and is obtained by summing the sub-scores from each part, with a higher score indicating better cognitive function. To determine the cognitive performance of participants, their scores will be compared to their age- and education-specific standards.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline self-reported appetite of people with MCI/dementia at 10 weeks
measured by a single question asking to what extent (1 to 10) the participant agrees the appetite is good. Score 1 refers to not agree at all and score 10 refers to totally agree. Higher score indicates better appetite. Ten smileys will be used to visualize the different extent.
Measured: 10 weeks after baseline
Change from baseline self-reported appetite of people with MCI/dementia at 20 weeks
measured by a single question asking to what extent (1 to 10) the participant agrees the appetite is good. Score 1 refers to not agree at all and score 10 refers to totally agree. Higher score indicates better appetite. Ten smileys will be used to visualize the different extent.
Measured: 20 weeks after baseline
Change from baseline self-reported appetite of people with MCI/dementia at 30 weeks
measured by a single question asking to what extent (1 to 10) the participant agrees the appetite is good. Score 1 refers to not agree at all and score 10 refers to totally agree. Higher score indicates better appetite. Ten smileys will be used to visualize the different extent
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline meaning in life of psychological well-being of people with MCI/dementia at 10 weeks
Measured by two questions asking to what extent (1 to 10) the participant agrees with there is purpose and meaning in life, respectively. Score 1 refers to not agree at all and score 10 refers to totally agree. Ten smileys will be used to visualize the different extent.
Measured: 10 weeks after baseline
Change from baseline meaning in life of psychological well-being of people with MCI/dementia at 20 weeks
Measured by two questions asking to what extent (1 to 10) the participant agrees with there is purpose and meaning in life, respectively. Score 1 refers to not agree at all and score 10 refers to totally agree. Ten smileys will be used to visualize the different extent.
Measured: 20 weeks after baseline
Change from baseline meaning in life of psychological well-being of people with MCI/dementia at 30 weeks
Measured by two questions asking to what extent (1 to 10) the participant agrees with there is purpose and meaning in life, respectively. Score 1 refers to not agree at all and score 10 refers to totally agree. Ten smileys will be used to visualize the different extent.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline Happiness of psychological well-being of people with MCI/dementia at 10 weeks
Measured by a single question asking about the extent of happiness in the past two months. Score 1 refers to not happy at all and score 10 refers to total happiness. Ten smileys will be used to visualize the different extent.
Measured: 10 weeks after baseline
Change from baseline Happiness of psychological well-being of people with MCI/dementia at 20 weeks
Measured by a single question asking about the extent of happiness in the past two months. Score 1 refers to not happy at all and score 10 refers to total happiness. Ten smileys will be used to visualize the different extent.
Measured: 20 weeks after baseline
Change from baseline Happiness of psychological well-being of people with MCI/dementia at 30 weeks
Measured by a single question asking about the extent of happiness in the past two months. Score 1 refers to not happy at all and score 10 refers to total happiness. Ten smileys will be used to visualize the different extent.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline food-related life satisfaction of psychological well-being of people with MCI/dementia at 10 weeks
Measured by the Satisfaction With Food-Related Life (SWFL) scale (Grunert et al., 2007). Total score ranges from 5 to 30. A higher score indicates a greater level of food-related life satisfaction.
Measured: 10 weeks after baseline
Change from baseline food-related life satisfaction of psychological well-being of people with MCI/dementia at 20 weeks
Measured by the Satisfaction With Food-Related Life (SWFL) scale (Grunert et al., 2007). Total score ranges from 5 to 30. A higher score indicates a greater level of food-related life satisfaction.
Measured: 20 weeks after baseline
Change from baseline food-related life satisfaction of psychological well-being of people with MCI/dementia at 30 weeks
Measured by the Satisfaction With Food-Related Life (SWFL) scale (Grunert et al., 2007). Total score ranges from 5 to 30. A higher score indicates a greater level of food-related life satisfaction.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline self-esteem of psychological well-being of people with MCI/dementia at 10 weeks
Measured by the Chinese version of the Rosenberg Self-Esteem Scale (RSE), containing 10 items. Higher total score indicating higher self-esteem (Yeung, 1998).
Measured: 10 weeks after baseline
Change from baseline self-esteem of psychological well-being of people with MCI/dementia at 20 weeks
Measured by the Chinese version of the Rosenberg Self-Esteem Scale (RSE), containing 10 items. Higher total score indicating higher self-esteem (Yeung, 1998).
Measured: 20 weeks after baseline
Change from baseline self-esteem of psychological well-being of people with MCI/dementia at 30 weeks
Measured by the Chinese version of the Rosenberg Self-Esteem Scale (RSE), containing 10 items. Higher total score indicating higher self-esteem (Yeung, 1998).
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline family harmony and satisfaction of people with MCI/dementia at 10 weeks
measured by Chinese version of 5-item Family Harmony Scale (FHS-5) (Kavikondala et al., 2016). Five related questions asking to what extent (1 to 5) the participant agrees with the statement. These questions include (1) my family functions well for all members, (2) my family's day-to-day interactions are peaceful, (3) family members accommodate each other, (4) I am proud of my family, and (5) my family is harmonious. Score 1 refers to strongly agree, score 2 refers to agree, score 3 refers to neutral, score 4 refers to disagree, and score 5 refers to strongly disagree. Total score ranges from 5 to 25. Higher score indicates worse family harmony and satisfaction.
Measured: 10 weeks after baseline
Change from baseline family harmony and satisfaction of people with MCI/dementia at 20 weeks
measured by Chinese version of 5-item Family Harmony Scale (FHS-5) (Kavikondala et al., 2016). Five related questions asking to what extent (1 to 5) the participant agrees with the statement. These questions include (1) my family functions well for all members, (2) my family's day-to-day interactions are peaceful, (3) family members accommodate each other, (4) I am proud of my family, and (5) my family is harmonious. Score 1 refers to strongly agree, score 2 refers to agree, score 3 refers to neutral, score 4 refers to disagree, and score 5 refers to strongly disagree. Total score ranges from 5 to 25. Higher score indicates worse family harmony and satisfaction.
Measured: 20 weeks after baseline
Change from baseline family harmony and satisfaction of people with MCI/dementia at 30 weeks
measured by Chinese version of 5-item Family Harmony Scale (FHS-5) (Kavikondala et al., 2016). Five related questions asking to what extent (1 to 5) the participant agrees with the statement. These questions include (1) my family functions well for all members, (2) my family's day-to-day interactions are peaceful, (3) family members accommodate each other, (4) I am proud of my family, and (5) my family is harmonious. Score 1 refers to strongly agree, score 2 refers to agree, score 3 refers to neutral, score 4 refers to disagree, and score 5 refers to strongly disagree. Total score ranges from 5 to 25. Higher score indicates worse family harmony and satisfaction.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline self-rated health of people with MCI/dementia at 10 weeks
measured by a single question asking the participant to rate his or her health (Lam et al., 1998). Score 1 refers to excellent, score 2 refers to very good, score 3 refers to good, score 4 refers to fair, and score 5 refers to poor.
Measured: 10 weeks after baseline
Change from baseline self-rated health of people with MCI/dementia at 20 weeks
measured by a single question asking the participant to rate his or her health (Lam et al., 1998). Score 1 refers to excellent, score 2 refers to very good, score 3 refers to good, score 4 refers to fair, and score 5 refers to poor.
Measured: 20 weeks after baseline
Change from baseline self-rated health of people with MCI/dementia at 30 weeks
measured by a single question asking the participant to rate his or her health (Lam et al., 1998). Score 1 refers to excellent, score 2 refers to very good, score 3 refers to good, score 4 refers to fair, and score 5 refers to poor.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline confidence in care recipient's cooking of caregivers at 10 weeks
measured by a single question in the questionnaire asking to what extent (1 to 10) the caregiver trusts the care recipient to cook themselves. Score 1 refers to not trust at all and score 10 refers to complete trust.
Measured: 10 weeks after baseline
Change from baseline confidence in care recipient's cooking of caregivers at 20 weeks
measured by a single question in the questionnaire asking to what extent (1 to 10) the caregiver trusts the care recipient to cook themselves. Score 1 refers to not trust at all and score 10 refers to complete trust.
Measured: 20 weeks after baseline
Change from baseline confidence in care recipient's cooking of caregivers at 30 weeks
measured by a single question in the questionnaire asking to what extent (1 to 10) the caregiver trusts the care recipient to cook themselves. Score 1 refers to not trust at all and score 10 refers to complete trust.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline worried about future cooking ability and meal choices of care recipient of caregivers at 10 weeks
measured by three questions to what extent (1 to 10) the participant is worried about with the future cooking ability, choice of ingredients and cooking methods, respectively. Score 1 refers to completely worried and score 10 refers to not worried at all.
Measured: 10 weeks after baseline
Change from baseline worried about future cooking ability and meal choices of care recipient of caregivers at 20 weeks
measured by three questions to what extent (1 to 10) the participant is worried about with the future cooking ability, choice of ingredients and cooking methods, respectively. Score 1 refers to completely worried and score 10 refers to not worried at all.
Measured: 20 weeks after baseline
Change from baseline worried about future cooking ability and meal choices of care recipient of caregivers at 30 weeks
measured by three questions to what extent (1 to 10) the participant is worried about with the future cooking ability, choice of ingredients and cooking methods, respectively. Score 1 refers to completely worried and score 10 refers to not worried at all.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline caregiver burden at 10 weeks
measured by the Zarit Burden Interview (ZBI) scale (Chan et al., 2005; Schreiner et al., 2006; Zarit et al., 1980). The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0 and 88. Higher scores indicate a greater burden. A score of 17 or more was considered a high burden.
Measured: 10 weeks after baseline
Change from baseline caregiver burden at 20 weeks
measured by the Zarit Burden Interview (ZBI) scale (Chan et al., 2005; Schreiner et al., 2006; Zarit et al., 1980). The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0 and 88. Higher scores indicate a greater burden. A score of 17 or more was considered a high burden.
Measured: 20 weeks after baseline
Change from baseline caregiver burden at 30 weeks
measured by the Zarit Burden Interview (ZBI) scale (Chan et al., 2005; Schreiner et al., 2006; Zarit et al., 1980). The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0 and 88. Higher scores indicate a greater burden. A score of 17 or more was considered a high burden.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline meaning in life of psychological well-being of caregiver at 10 weeks
Measured by the Chinese version of the Meaning in Life Questionnaire. Total score ranged between 0 to 100. A higher total score indicates a greater sense of meaning in life.
Measured: 10 weeks after baseline
Change from baseline meaning in life of psychological well-being of caregiver at 20 weeks
Measured by the Chinese version of the Meaning in Life Questionnaire. Total score ranged between 0 to 100. A higher total score indicates a greater sense of meaning in life.
Measured: 20 weeks after baseline
Change from baseline meaning in life of psychological well-being of caregiver at 30 weeks
Measured by the Chinese version of the Meaning in Life Questionnaire. Total score ranged between 0 to 100. A higher total score indicates a greater sense of meaning in life.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline happiness of psychological well-being of caregiver at 10 weeks
Measured by the Chinese version of the 4-item Subjective Happiness Scale (SHS). The score is the average of the four items (1 to 7), a higher score indicates a higher level of subjective happiness.
Measured: 10 weeks after baseline
Change from baseline happiness of psychological well-being of caregiver at 20 weeks
Measured by the Chinese version of the 4-item Subjective Happiness Scale (SHS). The score is the average of the four items (1 to 7), a higher score indicates a higher level of subjective happiness.
Measured: 20 weeks after baseline
Change from baseline happiness of psychological well-being of caregiver at 30 weeks
Measured by the Chinese version of the 4-item Subjective Happiness Scale (SHS). The score is the average of the four items (1 to 7), a higher score indicates a higher level of subjective happiness.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline life satisfaction of psychological well-being of caregiver at 10 weeks
Measured by the Chinese version of the satisfaction with life scale (SWLS). Total score ranges from 5 to 35. A higher average score indicates a greater level of life satisfaction.
Measured: 10 weeks after baseline
Change from baseline life satisfaction of psychological well-being of caregiver at 20 weeks
Measured by the Chinese version of the satisfaction with life scale (SWLS). Total score ranges from 5 to 35. A higher average score indicates a greater level of life satisfaction.
Measured: 20 weeks after baseline
Change from baseline life satisfaction of psychological well-being of caregiver at 30 weeks
Measured by the Chinese version of the satisfaction with life scale (SWLS). Total score ranges from 5 to 35. A higher average score indicates a greater level of life satisfaction.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline life satisfaction of subjective well-being of caregiver at 10 weeks
Measured by the Chinese version of the World Health Organization Five Well-Being Index (WHO-5). The total raw score is multiplied by 4 to give the final score which ranges from 0 to 100, higher score indicates better well-being.
Measured: 10 weeks after baseline
Change from baseline life satisfaction of subjective well-being of caregiver at 20 weeks
Measured by the Chinese version of the World Health Organization Five Well-Being Index (WHO-5). The total raw score is multiplied by 4 to give the final score which ranges from 0 to 100, higher score indicates better well-being.
Measured: 20 weeks after baseline
Change from baseline life satisfaction of subjective well-being of caregiver at 30 weeks
Measured by the Chinese version of the World Health Organization Five Well-Being Index (WHO-5). The total raw score is multiplied by 4 to give the final score which ranges from 0 to 100, higher score indicates better well-being.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline family harmony and satisfaction of caregiver at 10 weeks
measured by Chinese version of 5-item Family Harmony Scale (FHS-5) (Kavikondala et al., 2016). Five related questions asking to what extent (1 to 5) the participant agrees with the statement. These questions include (1) my family functions well for all members, (2) my family's day-to-day interactions are peaceful, (3) family members accommodate each other, (4) I am proud of my family, and (5) my family is harmonious. Score 1 refers to strongly agree, score 2 refers to agree, score 3 refers to neutral, score 4 refers to disagree, and score 5 refers to strongly disagree. Total score ranges from 5 to 25. Higher score indicates worse family harmony and satisfaction.
Measured: 10 weeks after baseline
Change from baseline family harmony and satisfaction of caregiver at 20 weeks
measured by Chinese version of 5-item Family Harmony Scale (FHS-5) (Kavikondala et al., 2016). Five related questions asking to what extent (1 to 5) the participant agrees with the statement. These questions include (1) my family functions well for all members, (2) my family's day-to-day interactions are peaceful, (3) family members accommodate each other, (4) I am proud of my family, and (5) my family is harmonious. Score 1 refers to strongly agree, score 2 refers to agree, score 3 refers to neutral, score 4 refers to disagree, and score 5 refers to strongly disagree. Total score ranges from 5 to 25. Higher score indicates worse family harmony and satisfaction.
Measured: 20 weeks after baseline
Change from baseline family harmony and satisfaction of caregiver at 30 weeks
measured by Chinese version of 5-item Family Harmony Scale (FHS-5) (Kavikondala et al., 2016). Five related questions asking to what extent (1 to 5) the participant agrees with the statement. These questions include (1) my family functions well for all members, (2) my family's day-to-day interactions are peaceful, (3) family members accommodate each other, (4) I am proud of my family, and (5) my family is harmonious. Score 1 refers to strongly agree, score 2 refers to agree, score 3 refers to neutral, score 4 refers to disagree, and score 5 refers to strongly disagree. Total score ranges from 5 to 25. Higher score indicates worse family harmony and satisfaction.
Measured: 30 weeks after baseline, only for waitlist control group
Change from baseline self-rated health of caregiver at 10 weeks
measured by a single question asking the participant to rate his or her health (Lam et al., 1998). Score 1 refers to excellent, score 2 refers to very good, score 3 refers to good, score 4 refers to fair, and score 5 refers to poor.
Measured: 10 weeks after baseline
Change from baseline self-rated health of caregiver at 20 weeks
measured by a single question asking the participant to rate his or her health (Lam et al., 1998). Score 1 refers to excellent, score 2 refers to very good, score 3 refers to good, score 4 refers to fair, and score 5 refers to poor.
Measured: 20 weeks after baseline
Change from baseline self-rated health of caregiver at 30 weeks
measured by a single question asking the participant to rate his or her health (Lam et al., 1998). Score 1 refers to excellent, score 2 refers to very good, score 3 refers to good, score 4 refers to fair, and score 5 refers to poor.
Measured: 30 weeks after baseline, only for waitlist control group
Attendance rate
collected by class attendance record for face-to-face health education and cooking classes.
Measured: During 10 weeks intervention
Home practice rate
collected by a single question in the questionnaire asking how many times older adults with MCI/dementia and their caregivers have practiced cooking at home in the last two months.
Measured: 10, 20 weeks after baseline for intervention group. 10, 20 and 30 weeks after baseline for waitlist control group.
Drop-out rate
calculated by dividing the number of participants who drop-out from the study by the number of participants joining the study. If participants withdraw, reason of withdrawal will be recorded. If participants do not wish to reveal the reason of withdrawal, the project team will respect their preference.
Measured: During 20 weeks after baseline for intervention group. During 30 weeks after baseline for waitlist control group.
Programme satisfaction
measured by a single question asking to what extent (1 to 10) the participant/caregiver is satisfied with the program. Score 1 refers to not satisfactory at all and score 10 refers to very satisfactory.
Measured: 20 weeks after baseline for intervention group, 30 weeks after baseline for waitlist control group.
Recommendation to others
measured by a single question asking to what extent (1 to 10) the participant/caregiver is willing to recommend the programme to relatives or friends. Score 1 refers to not willing at all and score 10 refers to very willing to.
Measured: 20 weeks after baseline for intervention group, 30 weeks after baseline for waitlist control group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Oct 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Sheng Kung Hui Welfare Council Limited
- Responsible party
- Principal investigator, Dr. Pui-Hing Chau, The University of Hong Kong
- Investigators
- Pui Hing Chau, Principal investigator, School of Nursing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572748
- Sponsor's protocol ID
- EA240323
- Status last verified
- Nov 2024
- First submitted
- 20 Aug 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Study for the Chef Anchor 3.0 Program for Older People With Mild Cognitive Impairment/Dementia and Their Informal Caregivers
- ClinicalTrials.gov ID
- NCT06572748
- Acronym / sponsor ID
- EA240323
- Conditions
- Mild Cognitive Impairment, Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Sheng Kung Hui Welfare Council Limited
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 27 Aug 2024 (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.
Objectives:
- (Primary)To estimate the potential effects of the cooking program on the people with MCI/dementia and their informal caregivers;
- To investigate if the potential effects can be maintained after the completion of the program.
Study design and participants:
A convenience sample of 68 pair older adults with MCI/dementia and their informal caregivers from the Chef Anchor 3.0 Programme will be referred to the research team. Overall, participants will be assigned to intervention group and waitlist control group in a ratio of 1:1. Allocation will take into account the participants' availability and the programme capacity. Assessors of outcomes and data analyst will be blinded throughout the whole study.
During the first 10 weeks, the intervention group will undergo the 10-week programme in the "Chef Anchor 3.0", while no activity for the waitlist control group. Then, from week 10 to 20, the waitlist control group will attend the same 10-week programme.
Measurements:
Main outcome measures for people with MCI/dementia will include confidence in cooking (Primary), cooking capability, satisfaction with autonomy in cooking, Satisfaction with meal choices, Worried about future cooking ability and meal choices, cognitive function, self-reported appetite, psychological well-being, family harmony and satisfaction, as well as self-rated health.
Outcome measures for informal caregivers will include confidence in care recipient' s cooking, worried about future cooking ability and meal choices of care recipient, caregiver burden, psychological well-being, family harmony and satisfaction, as well as self-rated health.
Other measures will include attendance rate, home practice rate, drop-out rate, programme satisfaction, and recommendation to others.
Hypotheses
- The confidence in cooking, cooking capability, satisfaction with autonomy in cooking, satisfaction with meal choices, worried about future cooking ability and meal choices, cognitive function, self-reported appetite, psychological well-being, family satisfaction, and self-rated health of older adults with MCI/dementia would improve after the programme;
- The confidence in care recipient's cooking, worried about future cooking ability and meal choices of care recipient, psychological well-being, family satisfaction, caregiver burden, and self-rated health of informal caregivers would improve after the programme;
- The 10-week programme is acceptable for the most of older adults with MCI/dementia and their informal caregivers.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assigned intervention | Other | Other: 10-week programmeDuring the first 10 weeks, the intervention group will undergo the 10-week programme in the "Chef Anchor 3.0" |
| Assigned waitlist attention control | Other | Other: 10-week programmeDuring the first 10 weeks, no activity for the waitlist control group. Then, from week 10 to 20, the waitlist control group will attend the same 10-week programme. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 60 or above;
- Diagnosed by medical doctor has having MCI/dementia as reported by the older adults or their informal caregivers, or with reported subjective decline of cognitive function and with 5-min MoCA score ≤7th age- and education-specific percentile (Wong et al., 2015);
- Ability to follow simple instructions;
- Adequate physical strength to attend cooking workshops.
Key exclusion criteria (1 listed)
- Without caregiver
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 |
|---|---|---|
| 10-week programme1. 2-week health education (4 sessions, 60 minutes per session) Social workers and occupational therapists will explain the cognitive training elements of the program and introduce the "DementiAbility Methods" to the participants. Nutritionist, speech therapists, and Chinese medicine practitioner will share insights from their perspectives to enhance participants' understanding of cognitive impairments. 2. 8-week cooking class (5 sessions, 120 minutes per session) The culinary instructor will teach participants to cook homemade dishes while integrating "procedural memory" into recipes. Older adults and their caregivers will cook together based on the "procedural recipe" designed by caregivers, aiming to enhance communication between them and create joyful memories. The cooking class will begin with 20-30 minutes an interactive nutrition-based session. The session themes will focus on healthy diet and food safety. Participants will be able to ask questions and make comments. | Other | Assigned intervention, Assigned waitlist attention control |
Primary outcome
Change from baseline confidence in cooking of people with MCI/dementia at 10 weeks
Time frame: 10 weeks after baseline
measured by a single question asking to what extent (1 to 10) the participant feels confident with cooking a meal. Score 1 refers to no confidence and score 10 refers to very confident. Ten smileys will be used to visualize the different extent. This outcome is the primary outcome.
Change from baseline confidence in cooking of people with MCI/dementia at 20 weeks
Time frame: 20 weeks after baseline
measured by a single question asking to what extent (1 to 10) the participant feels confident with cooking a meal. Score 1 refers to no confidence and score 10 refers to very confident. Ten smileys will be used to visualize the different extent. This outcome is the primary outcome.
Change from baseline confidence in cooking of people with MCI/dementia at 30 weeks
Time frame: 30 weeks after baseline, only for waitlist control group
measured by a single question asking to what extent (1 to 10) the participant feels confident with cooking a meal. Score 1 refers to no confidence and score 10 refers to very confident. Ten smileys will be used to visualize the different extent. This outcome is the primary outcome.
68 secondary outcomes
Change from baseline cooking capability of people with MCI/dementia at 10 weeks
Time frame: 10 weeks after baseline
Change from baseline cooking capability of people with MCI/dementia at 20 weeks
Time frame: 20 weeks after baseline
Change from baseline cooking capability of people with MCI/dementia at 30 weeks
Time frame: 30 weeks after baseline, only for waitlist control group
Change from baseline satisfaction with autonomy in cooking of people with MCI/dementia at 10 weeks
Time frame: 10 weeks after baseline
Change from baseline satisfaction with autonomy in cooking of people with MCI/dementia at 20 weeks
Time frame: 20 weeks after baseline
Change from baseline satisfaction with autonomy in cooking of people with MCI/dementia at 30 weeks
Time frame: 30 weeks after baseline, only for waitlist control group
Change from baseline satisfaction with meal choices of people with MCI/dementia at 10 weeks
Time frame: 10 weeks after baseline
Change from baseline satisfaction with meal choices of people with MCI/dementia at 20 weeks
Time frame: 20 weeks after baseline
Change from baseline satisfaction with meal choices of people with MCI/dementia at 30 weeks
Time frame: 30 weeks after baseline, only for waitlist control group
Change from baseline worried about future cooking ability and meal choices of people with MCI/dementia at 10 weeks
Time frame: 10 weeks after baseline
Change from baseline worried about future cooking ability and meal choices of people with MCI/dementia at 20 weeks
Time frame: 20 weeks after baseline
Change from baseline worried about future cooking ability and meal choices of people with MCI/dementia at 30 weeks
Time frame: 30 weeks after baseline, only for waitlist control group
Change from baseline cognitive function of people with MCI/dementia at 10 weeks
Time frame: 10 weeks after baseline
Change from baseline cognitive function of people with MCI/dementia at 20 weeks
Time frame: 20 weeks after baseline
Change from baseline cognitive function of people with MCI/dementia at 30 weeks
Time frame: 30 weeks after baseline, only for waitlist control group
Change from baseline self-reported appetite of people with MCI/dementia at 10 weeks
Time frame: 10 weeks after baseline
Change from baseline self-reported appetite of people with MCI/dementia at 20 weeks
Time frame: 20 weeks after baseline
Change from baseline self-reported appetite of people with MCI/dementia at 30 weeks
Time frame: 30 weeks after baseline, only for waitlist control group
Change from baseline meaning in life of psychological well-being of people with MCI/dementia at 10 weeks
Time frame: 10 weeks after baseline
Change from baseline meaning in life of psychological well-being of people with MCI/dementia at 20 weeks
Time frame: 20 weeks after baseline
Change from baseline meaning in life of psychological well-being of people with MCI/dementia at 30 weeks
Time frame: 30 weeks after baseline, only for waitlist control group
Change from baseline Happiness of psychological well-being of people with MCI/dementia at 10 weeks
Time frame: 10 weeks after baseline
Change from baseline Happiness of psychological well-being of people with MCI/dementia at 20 weeks
Time frame: 20 weeks after baseline
Change from baseline Happiness of psychological well-being of people with MCI/dementia at 30 weeks
Time frame: 30 weeks after baseline, only for waitlist control group
Change from baseline food-related life satisfaction of psychological well-being of people with MCI/dementia at 10 weeks
Time frame: 10 weeks after baseline
Change from baseline food-related life satisfaction of psychological well-being of people with MCI/dementia at 20 weeks
Time frame: 20 weeks after baseline
Change from baseline food-related life satisfaction of psychological well-being of people with MCI/dementia at 30 weeks
Time frame: 30 weeks after baseline, only for waitlist control group
Change from baseline self-esteem of psychological well-being of people with MCI/dementia at 10 weeks
Time frame: 10 weeks after baseline
Change from baseline self-esteem of psychological well-being of people with MCI/dementia at 20 weeks
Time frame: 20 weeks after baseline
Change from baseline self-esteem of psychological well-being of people with MCI/dementia at 30 weeks
Time frame: 30 weeks after baseline, only for waitlist control group
Change from baseline family harmony and satisfaction of people with MCI/dementia at 10 weeks
Time frame: 10 weeks after baseline
Change from baseline family harmony and satisfaction of people with MCI/dementia at 20 weeks
Time frame: 20 weeks after baseline
Change from baseline family harmony and satisfaction of people with MCI/dementia at 30 weeks
Time frame: 30 weeks after baseline, only for waitlist control group
Change from baseline self-rated health of people with MCI/dementia at 10 weeks
Time frame: 10 weeks after baseline
Change from baseline self-rated health of people with MCI/dementia at 20 weeks
Time frame: 20 weeks after baseline
Change from baseline self-rated health of people with MCI/dementia at 30 weeks
Time frame: 30 weeks after baseline, only for waitlist control group
Change from baseline confidence in care recipient's cooking of caregivers at 10 weeks
Time frame: 10 weeks after baseline
Change from baseline confidence in care recipient's cooking of caregivers at 20 weeks
Time frame: 20 weeks after baseline
Change from baseline confidence in care recipient's cooking of caregivers at 30 weeks
Time frame: 30 weeks after baseline, only for waitlist control group
Change from baseline worried about future cooking ability and meal choices of care recipient of caregivers at 10 weeks
Time frame: 10 weeks after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Pui Hing Chau principal investigator
School of Nursing, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10-week programme in people with Mild Cognitive Impairment and Dementia, run by The University of Hong Kong 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 1 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: looking for participants now, as of the sponsor's last update on 12 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pui Hing Chau, PhD (3917 6626, phpchau@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline confidence in cooking of people with MCI/dementia at 10 weeks (time frame: 10 weeks after baseline). 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 12 Nov 2024.