MalnutritionPhase 2NCT00114582
Optimizing the Ambiance During Mealtimes in Dutch Nursing Homes
A Phase 2 study testing family style dinner in people with Malnutrition, run by Wageningen University at 1 site in Netherlands.
Trial summary
Optimizing the social and physical ambiance during mealtimes in Dutch nursing homes: implementation and evaluation of the effect with respect to quality of life, nutritional status and physical performance. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- family style dinner
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2002to Dec 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Nursing home residents with a chronic somatic disease and long term care
Who cannot join
- Residents were excluded when they were in a terminal phase of a disease, had total parenteral feeding or were not able to give informed consent due to their physical or mental condition.
Trial locations and contacts
1 site in 1 country.
About this study
Optimizing the social and physical ambiance during mealtimes in Dutch nursing homes: implementation and evaluation of the effect with respect to quality of life, nutritional status and physical performance.
Read the detailed description
Study design: During six months the intervention group had their meals in family style, and the control group received the usual tray services.
Hypothesis: We hypothesized that the intervention program had a positive effect on quality of life, food intake, body weight, physical performance, and biochemical data (hematocrit, hemoglobin, leucocytes, ferretin, albumin, homocysteine and folate) among the residents in the intervention group, while these outcome measures would regularly decline among the residents in the control group.
Site and participants: Nursing homes volunteered to participate in the study. In each nursing home there was a control and intervention ward. Only residents with a chronic somatic disorder were included. Residents were excluded when they were in a terminal phase of a disease, had total parenteral feeding or were not able to give informed consent due to their physical or mental condition. The ethical committee and the client board of the nursing homes and the medical ethical committee of Wageningen University approved the study protocol.
Intervention: The intervention program lasted for six months and was based on an inventory research of mealtime ambiance models in the Netherlands. The program consisted of five aspects: table dressing, food services, staff protocol, residents' protocol, and mealtime protocol. Before the start of the meal, tables were set with tablecloths, full cutlery and plates. The cooked meal was served in dishes and residents had the opportunity to choose between two kinds of vegetables, two kinds of meat and potatoes.
- Conditions
- Malnutrition
- Being tested
- family style dinner
- Keywords
- family style dinner, quality of life, nutritional status, nursing home residents
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
family style dinnerProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Quality of life
Physical performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2005 (estimated)
- Study startApr 2002
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114582
- Sponsor's protocol ID
- 2420.0021
- Status last verified
- Feb 2009
- First submitted
- 15 Jun 2005
- Last updated
- 13 Feb 2009
- Results posted
- No
Publications
Mathey MF, Vanneste VG, de Graaf C, de Groot LC, van Staveren WA. Health effect of improved meal ambiance in a Dutch nursing home: a 1-year intervention study. Prev Med. 2001 May;32(5):416-23. doi: 10.1006/pmed.2001.0816.
PubMed 11330991Nijs K, Vanneste V, de Graaf K, van Staveren W. [Project models to improve the ambiance during meal times in Dutch nursing homes: incentives and barriers for implementation]. Tijdschr Gerontol Geriatr. 2003 Dec;34(6):246-53. Dutch.
PubMed 15007956Nijs KA, de Graaf C, Kok FJ, van Staveren WA. Effect of family style mealtimes on quality of life, physical performance, and body weight of nursing home residents: cluster randomised controlled trial. BMJ. 2006 May 20;332(7551):1180-4. doi: 10.1136/bmj.38825.401181.7C. Epub 2006 May 5.
PubMed 16679331
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Ambiance During Mealtimes in Dutch Nursing Homes
- ClinicalTrials.gov ID
- NCT00114582
- Acronym / sponsor ID
- 2420.0021
- Conditions
- Malnutrition
- Keywords
- family style dinner, quality of life, nutritional status, nursing home residents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Apr 2002
- Study completion
- Dec 2003
- First posted
- 16 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Optimizing the social and physical ambiance during mealtimes in Dutch nursing homes: implementation and evaluation of the effect with respect to quality of life, nutritional status and physical performance.
Detailed description
Study design: During six months the intervention group had their meals in family style, and the control group received the usual tray services.
Hypothesis: We hypothesized that the intervention program had a positive effect on quality of life, food intake, body weight, physical performance, and biochemical data (hematocrit, hemoglobin, leucocytes, ferretin, albumin, homocysteine and folate) among the residents in the intervention group, while these outcome measures would regularly decline among the residents in the control group.
Site and participants: Nursing homes volunteered to participate in the study. In each nursing home there was a control and intervention ward. Only residents with a chronic somatic disorder were included. Residents were excluded when they were in a terminal phase of a disease, had total parenteral feeding or were not able to give informed consent due to their physical or mental condition. The ethical committee and the client board of the nursing homes and the medical ethical committee of Wageningen University approved the study protocol.
Intervention: The intervention program lasted for six months and was based on an inventory research of mealtime ambiance models in the Netherlands. The program consisted of five aspects: table dressing, food services, staff protocol, residents' protocol, and mealtime protocol. Before the start of the meal, tables were set with tablecloths, full cutlery and plates. The cooked meal was served in dishes and residents had the opportunity to choose between two kinds of vegetables, two kinds of meat and potatoes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nursing home residents with a chronic somatic disease and long term care
Key exclusion criteria (1 listed)
- Residents were excluded when they were in a terminal phase of a disease, had total parenteral feeding or were not able to give informed consent due to their physical or mental condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| family style dinner | Procedure or surgery | – |
Primary outcome
Nutritional status
Quality of life
Physical performance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2009.
- Background: PubMed 11330991Mathey MF, Vanneste VG, de Graaf C, de Groot LC, van Staveren WA. Health effect of improved meal ambiance in a Dutch nursing home: a 1-year intervention study. Prev Med. 2001 May;32(5):416-23. doi: 10.1006/pmed.2001.0816.
- Background: PubMed 15007956Nijs K, Vanneste V, de Graaf K, van Staveren W. [Project models to improve the ambiance during meal times in Dutch nursing homes: incentives and barriers for implementation]. Tijdschr Gerontol Geriatr. 2003 Dec;34(6):246-53. Dutch.
- Results publication: PubMed 16679331Nijs KA, de Graaf C, Kok FJ, van Staveren WA. Effect of family style mealtimes on quality of life, physical performance, and body weight of nursing home residents: cluster randomised controlled trial. BMJ. 2006 May 20;332(7551):1180-4. doi: 10.1136/bmj.38825.401181.7C. Epub 2006 May 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing family style dinner in people with Malnutrition, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00114582, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2009.