Condition category
Not Applicable
Date applied
11/01/2019
Date assigned
21/01/2019
Last edited
21/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Food bank users are often food insufficient and have poorer diet quality compared to non-users. Food parcels, supplied to food bank users, provide an opportunity to improve their diets. However, the content of these food parcels is not in line with dietary recommendations. This suggests that the nutritional guidelines for a healthy diet cannot be met if food supplied by food banks is the sole food source, which consequently may lead to higher risks on nutrition related chronic diseases. Therefore, we aimed to assess whether improving the nutritional quality of the food parcels, by adding healthy foods and removing unhealthy foods, will positively impact diet quality of food bank recipients.

Who can participate?
All food bank recipients of three selected food banks in the Netherlands (i.e. Alkmaar, Apeldoorn and Enschede) could participate if they were at least 18 years old, recipients for at least one month, possible to contact by phone, collect their own food parcel, and if they had an adequate command of the Dutch language to participate in oral and written interviews.

What does the study involve?
We performed a randomized controlled trial with cross-over design with two consecutive periods, lasting 4 weeks each. Per food bank, participants were randomly assigned to one of the six possible diet sequences. The study consisted of the following intervention conditions:

1. The control condition: the standard food parcel, with an additional non-food item.
2. Experimental condition 1: the standard food parcel in which snacks were replaced by staple foods, with an additional non-food item.
3. Experimental condition 2: the standard food parcel with additionally the recommended daily amount of fruit and vegetables for all household members for 7 days (4 days fresh, and 3 days non-perishable vegetables).
4. Experimental condition 3: the standard food parcel in which snacks were replaced by staple foods with additionally the recommended daily amount of fruit and vegetables for all household members for 7 days (4 days fresh, and 3 days non-perishable vegetables).

What are the possible benefits and risks of participating?
A possible benefit of the study is a healthier dietary intake. There are no side effects.

Where is the study run from?
The study was run from the Vrije University Amsterdam, Amsterdam, The Netherlands. Participating food banks were Alkmaar, Apeldoorn and Enschede, where measurements took place.

When is the study starting and how long is it expected to run for?
The study started 18 October 2012 and ended 10 January 2013. Per food bank, the study lasted 8 weeks.

Who is funding the study?
The study, which is part of the Food Bank Study, was funded by a grant from the Netherlands Organization for Health Research and Development (115100003)

Who is the main contact?
Judith Neter, email; judith.neter@vu.nl

Trial website

Not available

Contact information

Type

Scientific

Primary contact

Miss Judith Neter

ORCID ID

Contact details

De Boelelaan 1085
Amsterdam
1081 HV
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2010-18

Study information

Scientific title

The effect of improving the content of food parcels on dietary intake in Dutch food bank recipients - a randomized controlled trial

Acronym

Study hypothesis

Improving the content of food parcels will lead to healthier dietary intake of Dutch food bank recipients

Ethics approval

Does not require ethics approval: the Medical Ethical Committee of the VU Medical Center in Amsterdam, 29/09/2010, ref. 2010/278.

Study design

Randomized controlled trial, cross-over

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format. Please use contact details to request a participant information sheet

Condition

Dietary intake

Intervention

We performed a randomized crossover controlled trial with two consecutive periods, lasting 4 weeks each. Per food bank, the trial lasted 8 weeks in total. Per food bank, participants were randomly assigned by hand to one of the ten following possible sequences:
1. control condition - experimental condition 1
2. control condition - experimental condition 2
3. control condition - experimental condition 3
4. experimental condition 1 - control condition
5. experimental condition 1 - experimental condition 3
6. experimental condition 2 - control condition
7. experimental condition 2 - experimental condition 3
8. experimental condition 3 - control condition
9. experimental condition 3 - experimental condition 1
10. experimental condition 3 - experimental condition 2

The trial consisted of the following intervention conditions:
1. The control condition: the standard food parcel supplied by the food bank with an additional non-food item.
2. Experimental condition 1: the standard food parcel supplied by the food bank in which snacks (e.g. potato chips, cookies, chocolate) were replaced by staple foods (e.g. pasta, rice), with an additional non-food item.
3. Experimental condition 2: the standard food parcel supplied by the food bank with additionally the recommended daily amount of fruit (2 pieces) and vegetables (200 grams) for all household members for 7 days (4 days fresh, and 3 days non-perishable vegetables).
4. Experimental condition 3: the standard food parcel supplied by the food bank in which snacks (e.g. potato chips, cookies, chocolate) were replaced by staple foods (e.g. pasta, rice) with additionally the recommended daily amount of fruit (2 pieces) and vegetables (200 grams) for all household members for 7 days (4 days fresh, and 3 days non-perishable vegetables).

Intervention type

Other

Phase

Drug names

Primary outcome measure

Differences in dietary intake of the following food groups and nutrients (based on the Dutch Food Composition Table) between the intervention conditions were measured with multiple 24 hour recalls per participant at the end of each intervention condition (after 4 and after 8 weeks):
Nutrients:
1.Energy (kcal)
2. Protein (en%)
3. Mono- and disaccharides (en%)
4. Polysaccharides (en%)
5. Total fat (en%)
6. Saturated fat (en%)
7. Dietary fiber (g)
8. Vitamin C (mg)
9. Sodium (g)
10. Potassium (mg)
Food groups:
1. Vegetables (g)
2. Soya and vegetarian products (g)
3. Sugar, candy, sweet filling and sweet sauces (g)
4. Pastry and cookies (g)
5. Nuts, seeds and snacks (g)
6. Grains, flour, rice (g)
7. Fruit (g)

We did not calculate an overall score as a measure of diet quality. Therefore, the above mentioned outcomes are the primary outcomes.

Secondary outcome measures

N/A

Overall trial start date

20/10/2009

Overall trial end date

10/01/2013

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. >18 years of age
2. Adequate command of the Dutch language (oral and written)
3. Recipient of a Dutch food bank >1 month
4. Collect own food parcel at the food bank
5. Possible to be contacted by phone.

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

132

Participant exclusion criteria

N/A

Recruitment start date

05/10/2012

Recruitment end date

18/10/2012

Locations

Countries of recruitment

Netherlands

Trial participating centre

Voedselbank Enschede
Hoge Bothofstraat 45
Enschede
7511 ZA
Netherlands

Trial participating centre

Voedselbank Apeldoorn
Kanaal Noord 147
Apeldoorn
7317 AB
Netherlands

Trial participating centre

Voedselbank Alkmaar
Pettemerstraat 39B
Alkmaar
1823 CW
Netherlands

Sponsor information

Organisation

Vrije Universiteit Amsterdam

Sponsor details

De Boelelaan 1085
Amsterdam
1081 HV
Netherlands

Sponsor type

University/education

Website

www.vu.nl

Funders

Funder type

Research council

Funder name

The Netherlands Organization for Health Research and Development

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish a paper of the trial in April 2019.

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/04/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes