GAmified HOme-based COgnitive-Nutritional Training Feasibility Study

NCT05207930 | Unknown

• 1 other identifier: G-UAMH
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Cognitive frailty is an at-risk state of dementia that it can be reversed by manipulating the lifestyle factors, such as cognitive activity and nutrition/dietary pattern. Their protective effects depend on a prolonged adherence to these factors. However, in the literature, most of the cognitive interventions are centred-based and supervised. Nutrition intervention depends on the provision of supplement or a complimentary supply of food. There is a lack of interventions with components of sustaining cognitive and nutrition training effect for the community-dwelling older people with cognitive frailty in home settings. Objectives: This study aims to examine the feasibility and preliminary effects of a gamified, home-based, cognitive-nutritional training (GAHOCON) programme for community-dwelling older people with cognitive frailty on protective diet adherence, cognitive function, frailty nutrition, and body composition.

Conditions

Cognitive Frailty; Protective Diet Adherence; Cognitive Function; Frailty; Nutrition; Body Composition

Keywords

Cognitive frailty; Randomized controlled trial; Nutrition; Protective diets; Gamification; Home-based intervention

Outcome Measures

Primary Outcomes (1)

• Adherence to the Mediterranean diet

  Mediterranean diet was measured by the MedDietScore (MDS). The MDS covers two categories of items: beneficial foods (i.e., non-refined cereals, potatoes, fruits, vegetables, legumes, fish, and olive oil) and detrimental foods (i.e., red meat and products, poultry, full-fat dairy products, and alcohol). The MDS has demonstrated good criterion validity, showing a strong association with plasma and dietary fatty acids, and cardiovascular risks. Each MDS item is scored on a Likert scale from 0 to 5 to indicate the frequency of consumption, ranging from "never" to "daily" Summed MDS scores range from 0 to 55. A higher MDS indicates better adherence to the Mediterranean diet.

  Change is being assessed at 'baseline' (T0) and 'immediately after the completion of intervention' (T1), being 12 weeks apart

Study Arms (2)

Intervention Group

EXPERIMENTAL

This arm will undertake a centre-based health education on nutrition and cognitive frailty for 4 weeks, followed by an 8-week homed based gamified cognitive-nutrition training (GAHOCON).

Device: GAmified HOme-based COgnitive-Nutrition training (GAHOCON)

Control Group

PLACEBO COMPARATOR

This arm will undertake the same centre-based health education on nutrition and cognitive frailty for 4 weeks but will be opened to undertake a remotely supervised online open-source cognitive games, with which the contents are unrelated to nutrition, at the elderly community centre.

Device: Centre-based online open-source cognitive games

Interventions

GAmified HOme-based COgnitive-Nutrition training (GAHOCON) DEVICE

A home-based tablet game training, in which participants are expected to apply the nutrition knowledge they learn from the centre-based nutritional education and their cognitive functions. Participants in the intervention group are expected to engage in the home-based training regularly during those 8 weeks. A team of registered social workers working in the elderly community centre will monitor the progress, remind, set goals, and provide supports to the participant remotely on WhatsApp.

Intervention Group

Centre-based online open-source cognitive games DEVICE

During the 8 weeks in which the intervention group receives GAHOCON treatment, the control group will be introduced to some online open-source cognitive games (e.g. CogniFit) and are encouraged to play those games at the elderly community centre. However, the content of these games are unrelated to nutrition and the training is gamified to a less extent compared to GAHOCON. They will have free access to these online open-source cognitive games at the elderly community centre.

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60 years,
• Community-dwelling, as defined by living at home without staying in long-term care facilities (e.g., nursing home) in the last 12 months as reported by the participants,
• Cognitive frailty, as defined by co-existence of mild cognitive impairment and physical frailty,7
• Mild cognitive impairment, measured by Montreal Cognitive Assessment (MoCA) score ≤ 25 and Clinical Dementia Rating (CDR) score = 0.5,35,36 and
• Frailty status from pre-frail to frail, measured by Fried Frailty Phenotype score ≥ 1.37
• Poor Mediterranean diet adherence, measured by MDS score \< 30.5 (i.e., the mean MDS of community-dwelling older people reported in a local study),20 and
• Functionally independent on food preparation, as defined by Lawton Instrumental Activity of Daily Living score ≥ 15/18 with the sub-score on Meal Preparation = 2/2.38,39

You may not qualify if:

• Diagnosed dementia, according to subjects' medical record, or
• Probable dementia, as defined by MoCA ≤ 18,35,36
• Low vision (at least one eye with visual acuity \< 20/60) or without corrective lens, because all training are visual-based and blurred vision negatively affects cognitive performance in cognitive training and assessment.40

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Tung Wah College: collaborator
• Mindvivid: collaborator

Related Publications (1)

• Kwan RYC, Law QPS, Tsang JTY, Lam SH, Wang KT, Sin OSK, Cheung DSK. The Effect of the Mediterranean Diet-Integrated Gamified Home-Based Cognitive-Nutritional (GAHOCON) Training Programme for Older People With Cognitive Frailty: Pilot Randomized Controlled Trial. JMIR Rehabil Assist Technol. 2024 Dec 13;11:e60155. doi: 10.2196/60155.

  PMID: 39671585 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors at both pre- and post-observations will be blinded to the group label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 40 eligible subjects will be randomly assigned into 2 groups, with block sizes of 8 people in a ratio of 1:1. The intervention group will undertake a 4-week centre-based training followed by an 8-week home-based gamified cognitive-nutrition training (i.e., GAHOCON). Meanwhile, the control group will also receive the same 4-week centre-based training. Afterwards, the control group will be introduced to some open-source cognitive game and will be encouraged to participate in these games in the elderly centre. In other words, the control will not receive the GAHOCON treatment at all.

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 26, 2022
• Study Start: May 1, 2022
• Primary Completion: May 14, 2022
• Study Completion: May 14, 2022
• Last Updated: January 26, 2022

Record last verified: 2021-10