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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lisette de Groot, Wageningen University
ClinicalTrials.gov Identifier:
NCT01509222
First received: January 9, 2012
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Personalized nutrition counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Changing Dietary Patterns: an Individually Tailored Nutrition Intervention

Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Changes in dietary pattern [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Dietary behaviour [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Behavioral factors influencing dietary intake like barriers for having a healthy diet.

  • Health outcomes [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Health outcome measure are; BMI, waist and hip circumference, blood lipids (cholesterol and triglycerides) and blood pressure

  • Markers of intake [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

    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.



Enrollment: 186
Study Start Date: September 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Personalized nurition counseling
Personalized nutrition counseling based on dietary intake and motivation to change.
Behavioral: Personalized nutrition counseling
Other Name: Personalized nutrition counseling
No Intervention: Control
No intervention, control group.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509222

Locations
Netherlands
Wageningen University
Wageningen, Gelderland, Netherlands, 6703HD
Sponsors and Collaborators
Wageningen University
Investigators
Principal Investigator: Jeanne HM De Vries, Dr. Departement Human Nutrition, Wageningen University
  More Information

No publications provided

Responsible Party: Lisette de Groot, (Hooft van Huysduynen), Wageningen University
ClinicalTrials.gov Identifier: NCT01509222     History of Changes
Other Study ID Numbers: NL36582.081.11
Study First Received: January 9, 2012
Last Updated: April 24, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Wageningen University:
Health promotion
Dietary Counseling

ClinicalTrials.gov processed this record on September 18, 2014