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

Obesity Clinical Trial

Official title:

Changing Dietary Patterns: an Individually Tailored Nutrition Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509222
• Other study ID #: NL36582.081.11
• Status: Completed
• Phase: N/A
• First received: January 9, 2012
• Last updated: April 24, 2013
• Start date: September 2011
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Personalized nutrition counseling

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Dietary behaviour	Behavioral factors influencing dietary intake like barriers for having a healthy diet.	baseline and 6 months	No
Secondary	Health outcomes	Health outcome measure are; BMI, waist and hip circumference, blood lipids (cholesterol and triglycerides) and blood pressure	baseline and 6 months	No
Secondary	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	No