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

NCT01509222 | Completed

• 1 other identifier: NL36582.081.11
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Health promotion; Dietary Counseling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Dietary behaviour

  baseline and 6 months

• Health outcomes

  baseline and 6 months

• Markers of intake

  baseline and 6 months

Study Arms (2)

Personalized nurition counseling

OTHER

Personalized nutrition counseling based on dietary intake and motivation to change.

Behavioral: Personalized nutrition counseling

Control

NO INTERVENTION

No intervention, control group.

Interventions

Personalized nutrition counseling BEHAVIORAL

Personalized nurition counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least aged 18 years
• Having one child aged 4 to 12 years
• Written informed concent has been obtained

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6703HD, Netherlands

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeanne HM De Vries, Dr.

  Departement Human Nutrition, Wageningen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: (Hooft van Huysduynen)

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 12, 2012
• Study Start: September 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 25, 2013

Record last verified: 2013-04

Locations

NL (1)