ISRCTN ISRCTN16437456
DOI https://doi.org/10.1186/ISRCTN16437456
Secondary identifying numbers 200130001
Submission date
03/02/2017
Registration date
09/03/2017
Last edited
07/05/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
The aim of this study is to assess the effects of the course ‘Good food does not need to be expensive’ on diet and product choice. The course aims to increase dietary variety, decrease the intake of saturated fat, and increase consumption of fruit and vegetables among people with financial problems. The key message of the course is that healthy eating does not need to be expensive, thus trying to remove a barrier to healthy eating that is often perceived by people who have little money to spend. The course comprises of two two-hour sessions, led by a dietician, as part of an obligatory household budgeting course for people with financial problems. The course uses strategies such as skills training, information, active learning and tasting. This study aims to update and test the course, including an assessment of the long-term effects.

Who can participate?
People age 18-90 with a low income who live in neighborhoods in Limburg

What does the study involve?
Participants in one neighbourhood attend either two sessions on healthy affordable foods or a seven-session budgeting course including the nutrition sessions. Participants in a different neighbourhood attend the budgeting courses without the nutrition sessions. Before, immediately after the courses and at a follow-up test six months after the courses, all participants are contacted by telephone and asked about their diet, including their intake of calories, saturated fat, and fruit and vegetables.

What are the possible benefits and risks of participating?
Participants receive personal advice on their diet. There are no risks of participating in the study.

Where is the study run from?
Maastricht University (Netherlands)

When is the study starting and how long is it expected to run for?
November 2011 to November 2014

Who is funding the study?
Netherlands Organisation for Health Research and Development (Netherlands)

Who is the main contact?
Dr Kathelijne Bessems
k.bessems@maastrichtuniversity.nl

Contact information

Dr Kathelijne Bessems
Scientific

PO Box 616
Maastricht
6200MD
Netherlands

Phone +31 (0)433 882 829
Email k.bessems@maastrichtuniversity.nl

Study information

Study designQuasi-experimental control group design with a pretest, posttest directly after the program and a follow-up test after six months
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Community
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleAn update and evaluation study of the course ‘Good food does not need to be expensive’
Study objectivesThis study examines the effectiveness of the Good and Healthy Food programme among low income adults in deprived neighboorhoods or adults in debt repayment. Hypotheses are that the program supports participants in reducing their saturated fat intake and in increasing their intake of fruits and vegetables.
Ethics approval(s)The study was exempt from ethical review by the Medical Ethical Committee of the MUMC+, 23/05/2012
Health condition(s) or problem(s) studiedObesity, diabetes, cardiovascular diseases, cancer, osteoporosis and dental diseases
InterventionThe main goal of this project is to assess the effects of the intervention ‘Good food does not need to be expensive’ on dietary intake and product choice. The intervention is currently certified as ‘theoretically well founded’ by the Centre for Healthy Living. The intervention aims to increase dietary variety, decrease the intake of saturated fat, and increase consumption of fruit and vegetables among people with a limited income. The key message of the intervention is that healthy eating does not need to be expensive, thus trying to remove a barrier to healthy eating that is often perceived by people who have little money to spend. The intervention comprises of two two-hour sessions, led by a dietician. The intervention is organized as part of an obligatory household budgeting course for people with financial problems or as a standalone intervention in low SES neighborhoods. The intervention uses evidence-based intervention methods and strategies such as skills training, information, active learning and tasting.

This project aims to update the intervention using key aspects of the intervention mapping protocol and to evaluate it, including an assessment of the long-term effects. An effectiveness study will be conducted among 100 participants of 20 nutrition education courses. All courses are led by a dietician.

People in region A were automatically enrolled in the intervention condition, while people in region B were automatically enrolled in the control condition:
1. People in the intervention group either participate in the standalone intervention (two sessions on healthy affordable foods) organized in a low SES community or in a 7-session budgeting course (including the same two sessions on healthy affordable foods). The budgeting course is organized as part of a debt repayment trajectory.
2. People in the control group are recruited in other neighboring low SES communities; about half of them participate in comparable budgeting courses. The control group receives no education on the topic of healthy food.

A quasi-experimental design with a pretest, a posttest immediately after the course and a follow-up test six months after the course will be conducted, using multiple telephone 24-hour dietary recalls with intake of energy, (saturated) fat, and fruit and vegetables as primary outcome measures. Process data will be collected using observations, structured telephone and personal interviews with participants and dieticians.
Intervention typeBehavioural
Primary outcome measure1. Daily saturated fat intake in grams and energy percentage
2. Daily energy intake in kcal
3. Daily vegetable intake in grams
4. Daily fruit intake in portions
These outcomes are all measured by means of 24-hour recall telephone interviews by trained interviewers at three points in time: baseline before program implementation, posttest within a month after program implementation and at follow-up six months after program implementation. At each time point three recalls are collected (two measurements on a week day and one measurement on a weekend day). For each measurement data is collected on one weekend day and two week days. The estimated total enrollment period is 21 months. The phone calls take place in the evening and the participants do not know on which days they will be called. They are questioned about the foods and drinks they have taken during the day, yesterday’s hot meal as well as foods and drinks consumed yesterday evening.
Secondary outcome measures1. Food choice behaviors and change among outcomes, assessed using the same dietary recalls as described in the primary outcome measures section:
1.1. Number and type of meals a day
1.2. Consumption of snacks
1.3. Intake of nutrients
2. Implementation data, assessed by means of a structured observation of each session by a researcher and a brief interview with the dietician directly after the session
3. Program appreciation by participants, assessed by means of a telephone interview with participants within two weeks after the second program session
Overall study start date01/11/2011
Completion date01/11/2014

Eligibility

Participant type(s)Other
Age groupAdult
Lower age limit18 Years
Upper age limit90 Years
SexBoth
Target number of participants100 participants for the intervention group and 100 participants for the control group
Total final enrolment237
Key inclusion criteria1. Age 18-90
2. Low income
3. Region: low SES neighborhoods in Limburg
The intention is to recruit a diverse group regarding age, gender, employment status, family status and migrant status
Key exclusion criteriaHigh income
Date of first enrolment01/10/2012
Date of final enrolment01/07/2014

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Maastricht University, Department of Health Promotion
Peter Debeyeplein 1
Maastricht
6200MD
Netherlands

Sponsor information

ZonMW Netherlands
Research council

PO Box 93245
The Hague
2509 AE
Netherlands

Phone +31 (0)70 349 5111
Email info@zonmw.nl
Website www.zonmw.nl
ROR logo "ROR" https://ror.org/01yaj9a77

Funders

Funder type

Research council

ZonMw
Private sector organisation / Other non-profit organizations
Alternative name(s)
Netherlands Organisation for Health Research and Development
Location
Netherlands

Results and Publications

Intention to publish date01/11/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe trialists will write a research report directly after finishing the program. They will further publish the results of the effect and process evaluation as well as the implementation study in national and international (scientific) journals within 5 years after finishing the project. Further, they aim to disseminate the intervention itself at the national level by developing a training module for dieticians and keep the program materials up to date for further use. They aim to do this within 1 year after the project has ended.
IPD sharing planThe current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 07/04/2020 07/05/2020 Yes No

Editorial Notes

07/05/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.