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Completed

NCT Number: NCT01509222

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University

Wageningen, Gelderland, 6703HD, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Personalized nutrition counseling

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. Dietary behaviour

    Time frame: baseline and 6 months

    Behavioral factors influencing dietary intake like barriers for having a healthy diet.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Official study title

Changing Dietary Patterns: an Individually Tailored Nutrition Intervention

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 12, 2012
Registry last updated
Apr 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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