|- candidate number||28255|
|- NTR Number||NTR6849|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-nov-2017|
|- Secondary IDs||NL 678732 European Commission at the 7th Framework Programme (H2020-SFS-2015-2)|
|- Public Title||PILOT STUDY 2 ¡®Prevention Of Malnutrition In Senior Subjects (PROMISS)¡¯|
|- Scientific Title||PILOT STUDY 2 ¡®Prevention Of Malnutrition In Senior Subjects (PROMISS)¡¯|
|- ACRONYM||PROMISS Pilot study 2|
|- hypothesis||With the European population growing older, the challenge is to keep an increasing number of seniors across all European countries healthy and active. In Europe, between 13.5 % and 29.7 % of older adults living at home are (at risk of) protein energy malnutrition (PEM), which results in serious health problems. The overall aim of the Horizon 2020 project PRevention Of Malnutrition In older Senior Subjects (PROMISS) is to better understand and ultimately prevent PEM in seniors, by developing optimal, sustainable and evidence-based dietary and physical activity strategies to prevent malnutrition and enhance active and healthy aging.
This pilot study will be conducted to optimize the design and intervention strategies for the long-term prevention trial which is part of PROMISS.
|- Healt Condition(s) or Problem(s) studied||Community-dwelling, Protein energy malnutrition|
|- Inclusion criteria||- Age ¡İ 70 years|
- Lower protein intake (< 1.0 g/kg/body weight) based on a short food list that is developed and validated using an extended FFQ among Dutch older adults (data available on request)
- Able to eat independently
- Willing to eat our provided products
- Able to speak, write and read the Dutch language
|- Exclusion criteria||- Bedridden or wheelchair bound|
- Individuals who do not go outside
- Diagnosed severe kidney disease
- History of active malignancy (with the exception of basal cell carcinoma)
- Low cognitive status (MMSE score < 18)
- Obesity, defined as BMI > 30.0 kg/m2
- Allergies to certain food products (such as peanuts, gluten)
- Current participation to supervised behavioral or lifestyle interventions that intervene with PROMISS interventions
- Vacation plans for more than 5 days
- Planned to move out of the study area in the next 8 weeks
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2018|
|- planned closingdate||31-mei-2018|
|- Target number of participants||100|
|- Interventions||This pilot study consists of two groups; an intervention group and a control group.
The intervention group (N=50) will receive advise on how to adhere to the dietary advice on: 1) replacing habitual products with the newly developed protein rich food products; and 2) consumption of the newly developed protein rich food products in addition to their regular diet in close proximity of regular physical activity. The intervention and control group (N=100) both receive a standard brochure of the Netherlands Nutrition Centre with general information about healthy eating habits. The control group (N=50) receives no further intervention.
|- Primary outcome||The main study parameter of this pilot study is change in total protein intake (g/day). |
|- Secondary outcome||Secondary parameters are: participants¡¯ appetite levels and body weight. In the intervention group only, we will examine amount and time of day of the newly developed protein rich food products consumption, the potential change in newly developed protein rich food products consumption over the study period and the impact of the intervention on food preparation and shopping. We will also study the easiness of integrating the concept dietary strategies (including products) in the current diet. In addition, the feasibility of persuasive technology will be investigated in a subgroup of people of the intervention group.|
|- Timepoints||6 measurements:
- 1 home visit
- 1 Telephone interview
- 1 Baseline visit at the clinic
- 2 Telephone interviews
- 1 Follow-up visit at the clinic
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||PhD Ilse Reinders|
|- CONTACT for SCIENTIFIC QUERIES||PhD Ilse Reinders|
|- Sponsor/Initiator ||Vrije Universiteit Amsterdam|
(Source(s) of Monetary or Material Support)
|European Commission at the 7th Framework Programme (H2020-SFS-2015-2)|
|- Brief summary||Potential participants will be recruited via local newspaper advertisements and flyers which will be distributed at locations where many community-dwelling older adults visit (such as neighborhood centers, waiting rooms at general practitioners, pharmacies), within the VU Amsterdam area. The advertisements and flyers provided to community-dwelling older adults will be accompanied by an information brochure and will invite potential participants to contact us if they would like to participate (by phone or mail), or to go to the PROMISS website where they can find additional information about the whole project, and specifically this experiment. In addition, they can check whether they fall within the main eligibility criteria (community-dwelling, lower protein intake). Eligible participants will be asked to contact us by phone or mail.
Participants who contacted the PROMISS research team (by phone or by e-mail) will be contacted by telephone for a further screening process in which all the eligibility criteria will be checked (apply inclusion- and exclusion criteria) along with their understanding of the study and what it will involve. We will then make an appointment for the home visit in order to provide more detailed information regarding the pilot study and perform the measurements.
During the baseline assessment (home visit) prior to the start of the intervention, we will perform a complete MMSE examination, provide further explain the experiment, explain and perform one 24-hour recall in order to assess actual food intake. An interviewer-administered questionnaire will be performed. In addition, the informed consent will be signed and participants will receive a standard brochure of the Netherlands Nutrition Centre with general information about healthy eating habits.
The start of the intervention (intervention group) and follow-up (both groups) assessment will take place at the study center at VU University, Amsterdam.
|- Main changes (audit trail)|
|- RECORD||24-nov-2017 - 12-dec-2017|