Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/02/2017
Date assigned
09/03/2017
Last edited
09/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kathelijne Bessems

ORCID ID

Contact details

PO Box 616
Maastricht
6200MD
Netherlands
+31 (0)433 882 829
k.bessems@maastrichtuniversity.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

200130001

Study information

Scientific title

An update and evaluation study of the course ‘Good food does not need to be expensive’

Acronym

Study hypothesis

This 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

The study was exempt from ethical review by the Medical Ethical Committee of the MUMC+, 23/05/2012

Study design

Quasi-experimental control group design with a pretest, posttest directly after the program and a follow-up test after six months

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Obesity, diabetes, cardiovascular diseases, cancer, osteoporosis and dental diseases

Intervention

The 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 type

Behavioural

Phase

Drug names

Primary outcome measures

1. 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 measures

1. 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 trial start date

01/11/2011

Overall trial end date

01/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

100 participants for the intervention group and 100 participants for the control group

Participant exclusion criteria

High income

Recruitment start date

01/10/2012

Recruitment end date

01/07/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

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

Sponsor information

Organisation

ZonMW Netherlands

Sponsor details

PO Box 93245
The Hague
2509 AE
Netherlands
+31 (0)70 349 5111
info@zonmw.nl

Sponsor type

Research council

Website

www.zonmw.nl

Funders

Funder type

Research council

Funder name

ZonMw

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

The 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 plan
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/11/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes