NCT04788446

Brief Summary

The object is to investigate the effects of a modified Mediterranean diet learning intervention program with a Mini-flipped game strategy on dietary behavior and cognitive function of elderly people in the community. The six communities were randomly assigned to the experimental group and the control group. The intervention group will last for 8 weeks. An eight-week Mediterranean diet learning program applying mini-flipped game-based learning strategies could improve dietary behavior and global cognitive function among elderly people living in the general community.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

March 5, 2021

Last Update Submit

March 12, 2023

Conditions

Keywords

Mini-flipped Game-based LearningMediterranean DietEating BehaviorCognitive Performance

Outcome Measures

Primary Outcomes (2)

  • Mediterranean Diet Score

    To measure the Mediterranean dietary behavior

    Change from baseline outcome measure at 8th week (post-test)

  • Nutrition Knowledge test for the Elderly

    To measure the nutrition knowledge

    Change from baseline outcome measure at 8th week (post-test)

Secondary Outcomes (2)

  • Montreal Cognitive Assessment score

    Change from baseline outcome measure at 8th week (post-test)

  • Cognitive Failures Questionnaire score

    Change from baseline outcome measure at 8th week (post-test)

Other Outcomes (2)

  • Pittsburgh Sleep Quality Index score

    Change from baseline outcome measure at 8th week (post-test)

  • Center for Epidemiological Studies Depression Scale score

    Change from baseline outcome measure at 8th week (post-test)

Study Arms (2)

Mini-flipped Game-based Learning

EXPERIMENTAL

1. group diet education, an interactive food card game, and guidance on the Mediterranean diet 2. once a week for 40 minutes. 3. lasts for 8 weeks

Behavioral: Mini-flipped Game-based Learning

Balanced diet

PLACEBO COMPARATOR

1. given a leaflet on balanced diet and nutrition among the elderly 2. lasts for 8 weeks

Behavioral: Balanced diet

Interventions

The intervention was 8 weeks, forty minutes adjusted Mediterranean diet learning plan once a week, which includes the 20 minutes for the Mediterranean food table game, and the 20 minutes for the Mediterranean diet nutrition course. The topic of the course includes the relationship between Mediterranean diet and dementia, knowledge of Mediterranean diet, how to integrate local food ingredients into the Mediterranean diet, etc.

Mini-flipped Game-based Learning
Balanced dietBEHAVIORAL

Given a balanced diet nutrition health education manual for the aged.

Balanced diet

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years and older
  • No visual, hearing, or mental impairment, and could speak Mandarin.
  • Are willing to participate in the study and fill out the volunteer consent form.

You may not qualify if:

  • Diagnosis of cognitive dysfunction, brain injury with loss of consciousness for more than 30 minutes, or other central nervous system disorders. The presence of impaired sensory problems.
  • Severe illnesses such as heart, liver, and lung failure, end-stage renal disease, total paralysis, terminal cancer or chemotherapy, and a diagnosis of mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Cheng-Chen Chou

    Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 9, 2021

Study Start

July 31, 2020

Primary Completion

May 30, 2021

Study Completion

May 31, 2021

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations