이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

GAmified HOme-based COgnitive-Nutritional Training Feasibility Study (GAHOCON)

2022년 1월 12일 업데이트: The Hong Kong Polytechnic University

GAmified HOme-based COgnitive-Nutritional Training (GAHOCON) for Older People With Cognitive Frailty: A Feasibility Study

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.

연구 개요

상세 설명

Methods: This study employs a pilot randomized controlled trial design. Recruitment will be conducted in elderly community centres. Participants who are aged ≥ 60 years, community-dwelling, and having cognitive frailty will be recruited. Participants will be randomized into either intervention or control group at a 1:1 ratio by permuted block randomization with a block size of 8 people. In the intervention group, participants will attend both centre-based training for one month and home-based training for 2 months. Health education on cognitive frailty and nutrition are included in the centre-based training. GAHOCON is included in the home-based training. The gamified cognitive-nutritional training employs digital gaming technology to develop a programme by combining cognitive training and nutrition education to promote the health of older people cognitive frailty. In the control group, participants will attend only the centre-based training. For the outcomes, this study will measure the feasibility in terms of the willingness of participants to be randomized, study participation rate, follow-up rates, response rates to questionnaires, adherence rate, level of participation of the tablet-based training, and time needed for data collection. Adherence to protective diets, cognitive function, frailty, nutrition, and body composition will be measured at baseline (T0), immediately after the completion of the intervention (T1). Convenience sampling will be employed to recruit 30-40 subjects for pilot testing. Feasibility indexes will be reported by descriptive statistics, such as mean with standard deviation and frequency with percentage. To test the hypothesis on the effects, a non-parametric test (i.e., Wilcoxon Signed-rank test) will be used to compare the outcome variables across time points to test the within-group effect in both groups separately. The level of significance was 0.05.

Significance: If this intervention is feasible and effective, this is going to provide a first of its kind home-based intervention to promote both cognitive functions and modify the dietary pattern of older people with cognitive frailty. First, it changes the cognitive training mode from a centre-based and supervised one to a home-based, self-paced, and tele-monitored one. Home-based training enables a more sustainable engagement of training for older people. This is particularly important during the COVID-19 pandemic period when all the elderly centres are closed. Home-based interventions are more accessible and convenient. It also solves the problem of space limitation in elderly centres in the community that more beneficiaries can be covered in space-limiting elderly centres. Second, it changes the mode of nutritional intervention from a supplement-based one to a daily-diet-based one. This intervention could enhance the nutrition and change their dietary pattern of community-dwelling older people with cognitive frailty by engaging them to protective diets, which ensures the sustainability of the beneficial effects of the protective diets towards cognitive frailty. Third, it changes the training mode from a training- and learning-oriented one to a gaming-oriented one. It brings more joy to community-dwelling older people even at the time when they are at home. It also fosters training adherence.

연구 유형

중재적

등록 (예상)

40

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

60년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Age ≥ 60 years,
  2. 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,
  3. Cognitive frailty, as defined by co-existence of mild cognitive impairment and physical frailty,7

    1. Mild cognitive impairment, measured by Montreal Cognitive Assessment (MoCA) score ≤ 25 and Clinical Dementia Rating (CDR) score = 0.5,35,36 and
    2. Frailty status from pre-frail to frail, measured by Fried Frailty Phenotype score ≥ 1.37
  4. 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
  5. 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

Exclusion Criteria:

  1. Diagnosed dementia, according to subjects' medical record, or
  2. Probable dementia, as defined by MoCA ≤ 18,35,36
  3. 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Intervention Group
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).

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.

위약 비교기: Control Group
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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Adherence to the Mediterranean diet
기간: Change is being assessed at 'baseline' (T0) and 'immediately after the completion of intervention' (T1), being 12 weeks apart
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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2022년 5월 1일

기본 완료 (예상)

2022년 5월 14일

연구 완료 (예상)

2022년 5월 14일

연구 등록 날짜

최초 제출

2022년 1월 12일

QC 기준을 충족하는 최초 제출

2022년 1월 12일

처음 게시됨 (실제)

2022년 1월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 1월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 1월 12일

마지막으로 확인됨

2021년 10월 1일

추가 정보

이 연구와 관련된 용어

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

GAmified HOme-based COgnitive-Nutrition training (GAHOCON)에 대한 임상 시험

  • Dartmouth-Hitchcock Medical Center
    Centers for Disease Control and Prevention
    완전한
    간질
    미국
  • Dartmouth-Hitchcock Medical Center
    Centers for Disease Control and Prevention
    모병
    간질
    미국
3
구독하다