Changing Dietary Patterns: an Individually Tailored Nutrition Intervention (OKE-study)

April 24, 2013 updated by: Lisette de Groot, Wageningen University

Changing Dietary Patterns: an Individually Tailored Nutrition Intervention

The main objective of this study is to investigate the effect of a personalized nutrition intervention on the dietary pattern of apparently healthy adults with one or more children aged 4 to 12 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Giving personalized nutrition advice is perceived to be more effective in changing dietary patterns than giving general information about healthy eating.

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Wageningen, Gelderland, Netherlands, 6703HD
        • Wageningen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least aged 18 years
  • Having one child aged 4 to 12 years
  • Written informed concent has been obtained

Exclusion Criteria:

  • Not meeting the inclusion criteria
  • Unable or unwilling to comply with the study procedures
  • Enrolled in another study during the same study period
  • Not being able to communicate (read, speak and write) in the Dutch language
  • Having a partner who has been enrolled in the study
  • Being pregnant or lactating during the study period or planning to become pregnant during the study period
  • Having a BMI lower than 18.5 or higher that 35 kg/m2
  • Using medication to lower cholesterol or being under control by a doctor for having too high cholesterol levels
  • Using medication to lower blood pressure or being under control by a doctor for having a high blood pressure.
  • Having diabetes type I or type II
  • Following a diet (medical or self-initiated) or planning to follow a diet during the study period
  • Undergoing a medical treatment that interferes with the intervention.
  • Having gained or lost more than 5 kg of body weight during the last 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Personalized nurition counseling
Personalized nutrition counseling based on dietary intake and motivation to change.
Behavioral: Personalized nutrition counseling
No Intervention: Control
No intervention, control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in dietary pattern
Time Frame: baseline and 6 months

Dietary pattern will be measured by scoring several aspects of the diet. There are 10 aspets included in the score; fruit consumption, vegetable consumption, fiber intake, fatty acids intake, trans fatty acids intake, physical activity, consumption occasions, alcohol intake, fish consumption and sodium intake.

The range of the score is from 0 to 100. The score will be based on the information of a Food Frequency Questionnaire and two 24 hour dietary recalls.
baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary behaviour
Time Frame: baseline and 6 months
Behavioral factors influencing dietary intake like barriers for having a healthy diet.
baseline and 6 months
Health outcomes
Time Frame: baseline and 6 months
Health outcome measure are; BMI, waist and hip circumference, blood lipids (cholesterol and triglycerides) and blood pressure
baseline and 6 months
Markers of intake
Time Frame: baseline and 6 months

Blood values of carotenoids and fish fatty acids will be used to assess whether measured changes in dietary pattern are also found in the blood.

Urinary potassium and sodium ratios will also be used to assess changes in dietary pattern.
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Investigators

  • Principal Investigator: Jeanne HM De Vries, Dr., Departement Human Nutrition, Wageningen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 12, 2012

Study Record Updates

Last Update Posted (Estimate)

April 25, 2013

Last Update Submitted That Met QC Criteria

April 24, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NL36582.081.11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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