- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07838142
Improving Diet Quality of Community-Dwelling Seniors Using a Community-Based Participatory Approach
This study implements a community co-designed educational intervention program to improve diet quality of community-dwelling seniors.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Zoe Lim, PhD
- Numéro de téléphone: +6583586255
- E-mail: zoe.lim@geri.com.sg
Lieux d'étude
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-
Singapore
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Singapore, Singapore, Singapour, 768024
- Geriatric Education & Research Institute, Yishun Community Hospital
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Contact:
- Zoe Lim, PhD
- Numéro de téléphone: +6583586255
- E-mail: zoe.lim@geri.com.sg
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria (Senior Participants):
- aged 60 years and above
- have at least one social risk factor as assessed by community-based providers, based on criteria defined by Singapore's Agency for Integrated Care
- able to understand and provide consent
Inclusion Criteria (Center Staff and Volunteers):
- aged 21 years and above,
- Active Ageing Centre (AAC) staff member, micro-jobber or volunteer
- able to understand and provide consent.
Exclusion Criteria (Senior Participants):
- living with helpers
- require diet with modified consistencies due to swallowing impairment
- moderate-severe dementia
- multiple or severe food allergies
- Stages 3, 4 or 5 Chronic kidney disease (CKD), or other medical conditions deemed unsuitable for participation
- concurrently participating in other nutrition and food literacy programmes, and
- unable to converse in English or Chinese
Exclusion Criteria (Center Staff and Volunteers):
- require diet with modified consistencies due to swallowing impairment
- moderate-severe dementia
- multiple or severe food allergies
- Stages 3, 4 or 5 Chronic kidney disease (CKD), or other medical conditions deemed unsuitable for participation
- concurrently participating in other nutrition and food literacy programmes, and
- unable to converse in English or Chinese
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention
This is a single-arm trial and so all participants will be in the intervention arm. |
The intervention is a food literacy workshop comprising 4 sessions held once every 2 weeks, up to 3 hours each. The main workshop themes are: 1) Practical ways to prepare simple and healthy meals; and 2) Basic nutrition knowledge related to the meals prepared, such as their nutrient components, links to chronic conditions and short/long-term health effects. These sessions include hands-on food preparation, tasting sessions, talks, group discussions and/or question and answer. Hands-on food preparation will focus on 'no-equipment' or 'light cooking' recipes. Food tasting involves everyday ingredients such as fruits, vegetables, proteins, nuts, seeds, spices, grains, and condiments. Group discussions will be facilitated by a study team member and will revolve around the specific themes of the workshop delivered on that day. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Global Diet Quality Score (GDQS)
Délai: Baseline to end of 8 weeks.
|
A questionnaire that captures all foods consumed by the individual respondent during a 24-hour reference period and classifies foods into their corresponding GDQS food groups. The overall GDQS score sums up points across food groups, totaling a possible range of 0-49. Higher scores denote better diet quality. |
Baseline to end of 8 weeks.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Knowledge and Literacy
Délai: Baseline to end of 8 weeks.
|
Knowledge regarding health eating self-rated on a 5-point Likert scale. Higher scores denote better self-rated knowledge |
Baseline to end of 8 weeks.
|
|
Behavior Change
Délai: Baseline to end of 8 weeks.
|
Self-selected factors influencing food choice and frequency of snacking behavior. |
Baseline to end of 8 weeks.
|
|
Adapted Nutrition Literacy Quiz
Délai: Baseline to end of 8 weeks.
|
A quiz that assesses the participant's nutrition literacy. |
Baseline to end of 8 weeks.
|
|
Adapted Food Literacy Scale
Délai: Baseline to end of 8 weeks.
|
A scenario-based assessment that tests the participant's food literacy across 4 domains: Planning, Selection, Preparation, and Eating. Each correct answer will be given one score, totaling a possible range of 0-4. |
Baseline to end of 8 weeks.
|
|
Brief Pittsburgh' Sleep Quality Index (B-PSQI)
Délai: Baseline to end of 8 weeks.
|
Subjective sleep quality is rated from 0 (very bad) to 3 (very good). Sleep duration is rated from < 5 hours (severe sleep deprivation) to > 7 hours (standard healthy recommendations). |
Baseline to end of 8 weeks.
|
|
Visual Analog Scales (VAS)
Délai: Baseline to end of 8 weeks.
|
Three domains (feelings of Stomach discomfort, Energy, and Mood) self-rated on a 0-10 VAS. Higher scores denote less stomach discomfort, better energy or better mood. |
Baseline to end of 8 weeks.
|
|
Body Mass Index (BMI)
Délai: Baseline to end of 8 weeks.
|
Weight (kg) divided by the square of height (m), a measure of obesity and overweightness. |
Baseline to end of 8 weeks.
|
|
Timed Up and Go (TUG)
Délai: Baseline to end of 8 weeks.
|
Participants are timed as they rose from a chair, walked 3-metres to-and-fro, and sat back down on the chair. A measure of physical function and performance. |
Baseline to end of 8 weeks.
|
|
University of California, Los Angeles (UCLA) 3-Item Loneliness Scale
Délai: Baseline to end of 8 weeks.
|
A 3-item questionnaire that assesses an individual's subjective feelings of loneliness and social isolation. Higher scores denote more loneliness. A score of 6-9 out of 9 indicated loneliness |
Baseline to end of 8 weeks.
|
|
Lubben Social Network Scale (LSNS-6)
Délai: Baseline to end of 8 weeks.
|
A 6-item validated instrument designed to measures the size, closeness, and frequency of a person's social interactions with family and friends. Possible range of scores is from 0 to 30. A score of <12 out of 30 indicated poor social network score, or at risk of social isolation. |
Baseline to end of 8 weeks.
|
|
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Délai: Baseline to end of 8 weeks.
|
A health-related quality of life questionnaire based on five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) across five levels. An index score will be computed based on specific country's value set, where max score is 1.000 (perfect health) and min score could be a negative value (health state that is "worse than dead"). Based on the official Singapore EQ-5D-5L value set, the index scores range from 1.000 down to -0.851. Visual-analogue scale score ranges from 0 to 100, with higher scores denoting better self-rated health. |
Baseline to end of 8 weeks.
|
|
Program Satisfaction
Délai: End of 8-week intervention.
|
Overall satisfaction with intervention program rated on a 5-point Likert scale. Higher point denotes better satisfaction. |
End of 8-week intervention.
|
|
Self-Efficacy of Health Messages Delivery
Délai: Baseline to end of 8 weeks.
|
Confidence in delivering health and nutrition-related messages, rated on 5-point Likert scale. |
Baseline to end of 8 weeks.
|
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Adapted Trust in the Community Health Worker Scale
Délai: End of 8 weeks
|
An adapted validated scale to measure participant's trust in the trainers. Each item is scored on a 4-point Likert scale. Scores are calculated as a mean of non-missing items, with possible range of score from 1.0 to 4.0. Higher scores denote higher trust. |
End of 8 weeks
|
Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-0092
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Ethics approval limits data use to the original study team, thus consent does not cover data sharing.
Informations sur les médicaments et les dispositifs, documents d'étude
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