- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Zoe Lim, PhD
- Telefonní číslo: +6583586255
- E-mail: zoe.lim@geri.com.sg
Studijní místa
-
-
Singapore
-
Singapore, Singapore, Singapur, 768024
- Geriatric Education & Research Institute, Yishun Community Hospital
-
Kontakt:
- Zoe Lim, PhD
- Telefonní číslo: +6583586255
- E-mail: zoe.lim@geri.com.sg
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Global Diet Quality Score (GDQS)
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Knowledge and Literacy
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
|
Adapted Trust in the Community Health Worker Scale
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2025-0092
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Ethics approval limits data use to the original study team, thus consent does not cover data sharing.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .