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

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: Obesity
• Intervention / Treatment: Behavioral: Personalized nutrition counseling

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

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

Study record dates

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: Health promotion; Dietary Counseling
• Other Study ID Numbers: NL36582.081.11