Changing Dietary Patterns: an Individually Tailored Nutrition Intervention (OKE-study)
This study has been completed.
Information provided by (Responsible Party):
Lisette de Groot, Wageningen University
First received: January 9, 2012
Last updated: April 24, 2013
Last verified: April 2013
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.
Behavioral: Personalized nutrition counseling
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
||Changing Dietary Patterns: an Individually Tailored Nutrition Intervention
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2013 (Final data collection date for primary outcome measure)
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.
Giving personalized nutrition advice is perceived to be more effective in changing dietary patterns than giving general information about healthy eating.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- At least aged 18 years
- Having one child aged 4 to 12 years
- Written informed concent has been obtained
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01509222
|Wageningen, Gelderland, Netherlands, 6703HD |
||Jeanne HM De Vries, Dr.
||Departement Human Nutrition, Wageningen University
||Lisette de Groot, (Hooft van Huysduynen), Wageningen University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 9, 2012
||April 24, 2013
||Netherlands: Medical Ethics Review Committee (METC)
Keywords provided by Wageningen University:
ClinicalTrials.gov processed this record on September 30, 2016