- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Zoe Lim, PhD
- Telefoonnummer: +6583586255
- E-mail: zoe.lim@geri.com.sg
Studie Locaties
-
-
Singapore
-
Singapore, Singapore, Singapore, 768024
- Geriatric Education & Research Institute, Yishun Community Hospital
-
Contact:
- Zoe Lim, PhD
- Telefoonnummer: +6583586255
- E-mail: zoe.lim@geri.com.sg
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Global Diet Quality Score (GDQS)
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Knowledge and Literacy
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2025-0092
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Ethics approval limits data use to the original study team, thus consent does not cover data sharing.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .