Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
08/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anke Oenema

ORCID ID

Contact details

Erasmus MC
University Medical Center
Department of Public Health
Room AE124
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 4087718/4038475
a.oenema@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Diet in Action (Voeding in Actie)

Study hypothesis

In weight management, avoidance of energy dense (i.e. rich in fat and/or sugar) and choosing energy poor, dietary-fibre-rich food is advocated. Small modifications in intake of energy-dense foods can prevent weight gain and induce modest weight loss. However, even when motivated to make small changes to the diet, it is often difficult to make and maintain these changes. This so-called intention-behaviour gap is likely to be reduced with Implementation Intentions (IIs).

II’s are specific action plans, defining where, and when to perform a particular action. With these action plans people are more likely to turn their intended behaviour into action. Effects of IIs have been found for relatively simple and singular behaviours. The present study will test the effects of implementation intentions for making changes in energy intake, a more complex behaviour. The II’s are added to a computer-tailored advice delivered in web-based format.

Questions addressed in this study are:
1. Can IIs contribute to making actual changes in energy intake?
2. Are II better suited to induce new healthy behaviours (e.g. increase intake of low energy products), avoid unhealthy behaviours (e.g. decrease intake of high energy products) or exchange unhealthy practices for healthy ones?
3. Which factors (e.g. cognitions, values, personality traits) distinguish people who put II into action from those who do not?

Ethics approval

Approval received from local ethics committee (Medisch Ethische Toetsings Commissie, Erasmus MC) on 1 April, 2006 (reference number: MEC 221.141/2002/260).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Weight management

Intervention

The intervention consisted of a web-based computer-tailored program aiming at reducing calorie intake. In the first part of the program the most important energy sources in the diet were identified based on the answers on an extensive food frequency questionnaire and personal feedback about these energy sources and suggestions to change was provided.

In the second part of the intervention, respondents had to make IIs defining how, where and when to perform a particular action. There were four different versions of the second part of the program; participants were randomly allocated by a computer to one of the conditions:
1. IIs to reduce the intake of high calorie products
2. IIs to replace high calorie products by low calorie products
3. IIs to increase intake of low calorie products
4. Control group, no II

Respondents were exposed to the intervention in a laboratory setting. All the intervention materials were provided once.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Height, weight and waist circumference measured by a trained research assistant. Energy intake (total and of specific food groups) measured by a self-administered validated food frequency questionnaire developed by Wageningen University.

Secondary outcome measures

Psychosocial variables.

Overall trial start date

01/09/2005

Overall trial end date

24/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 to 65 years
2. Motivated to work on weight (prevention of weight gain and/or losing weight)
3. Body Mass Index (BMI) more than 25
4. Sufficient understanding of the Dutch language

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

487

Participant exclusion criteria

Prescribed diet from dietician or physician

Recruitment start date

01/09/2005

Recruitment end date

24/05/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus MC, University Medical Center
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Center (Netherlands)

Sponsor details

Department of Public Health
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes