Administrative information
Title {1} | Effectiveness of personalized meal recommendation in improving dietary behaviors of Chinese community-dwelling elders: study protocol for a randomized controlled trial |
Trial registration {2a and 2b} | Chinese Clinical Trial Registry ChiCTR2300074912, registered on August 20, 2023. |
Protocol version {3} | Issue Date: August 18, 2023 Protocol Version: 8th version This manuscript details the protocol on the 8th version approved on August 18 2023. |
Funding {4} | This study was supported by Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (No. 2021-I2M-1–056) and Key R & D plan of Hunan Province (No. 2021SK2024) |
Author details {5a} | Institute of Medical Information, Chinese Academy of Medical Sciences and Peking Union Medical College Columbia University, School of Nursing National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention Department of Geriatrics, Peking Union Medical College Hospital |
Name and contact information for the trial sponsor {5b} | Trial Sponsor: Contact name: Jiao Li Email: li.jiao@imicams.ac.cn |
Role of sponsor {5c} | The funding organization did not participate in the design of the study and was not involved in data collection, management, analysis, interpretation, manuscript preparation, or the decision to submit the findings. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Usual nutrition support for the control group
Health education topics | Themes of courses |
---|---|
Food and nutrients | Food categories and food diversity |
Energy and macronutrient needs for the elderly | |
The role of micronutrients in healthy aging | |
Good resources for protein | |
Chinese geriatric nutrition guideline | Malnutrition risk self-screening |
Dietary patterns for the elderly | |
Food processing for seniors | |
Dietary supplements | |
Nutritional status and geriatric-associated conditions | Hypertension |
Diabetes | |
Osteoporosis | |
Sarcopenia |
Integrated nutrition support with personalized recommendations for the intervention group
Theoretical underpinnings
Development and deployment of a meal recommendation system
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Participant timeline {13}
Sample size {14}
Recruitment {15}
Assignment of interventions: allocation
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
Assignment of interventions: blinding
Who will be blinded {17a}
Procedure for unblinding if needed {17b}
Data collection and management
Plans for assessment and collection of outcomes {18a}
Outcome measure | Collection method | |
---|---|---|
Dietary behavior | Dietary diversity | IoT system log, DDS |
Diet quality | IoT system log, CDGI-E | |
Recommendation adherence | IoT system log | |
System usability and satisfaction | Satisfaction ratings | Questionnaire (CSAT) |
Ease of use ratings | Questionnaire (CES) | |
Nutritional status | Risk of malnutrition | Questionnaire (MNA-SF) |
Anthropometric measurements | Body mass index | Basic body measurement (body weight scale, height rod) |
Waist circumference | Basic body measurement (measuring tape) | |
Systolic blood pressure | Blood pressure monitor | |
Diastolic blood pressure | Blood pressure monitor | |
Skin folds | Basic body measurement (skinfold caliper) |