ObesityNCT01509222
Changing Dietary Patterns: an Individually Tailored Nutrition Intervention (OKE-study)
A study testing Personalized nutrition counseling in people with Obesity, run by Wageningen University at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Personalized nutrition counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least aged 18 years
- Having one child aged 4 to 12 years
- Written informed concent has been obtained
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changing Dietary Patterns: an Individually Tailored Nutrition Intervention
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.
Read the detailed description
Giving personalized nutrition advice is perceived to be more effective in changing dietary patterns than giving general information about healthy eating.
- Conditions
- Obesity
- Being tested
- Personalized nutrition counseling
- Keywords
- Health promotion, Dietary Counseling
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized nutrition counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Personalized nurition counseling | Other | Personalized nutrition counseling based on dietary intake and motivation to change. Receives: Behavioral: Personalized nutrition counseling |
| Control | No intervention | No intervention, control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 6 months
Secondary outcomes (3)
Dietary behaviour
Behavioral factors influencing dietary intake like barriers for having a healthy diet.
Measured: baseline and 6 months
Health outcomes
Health outcome measure are; BMI, waist and hip circumference, blood lipids (cholesterol and triglycerides) and blood pressure
Measured: baseline and 6 months
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.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisette de Groot, Wageningen University
- Investigators
- Jeanne HM De Vries, Dr., Principal investigator, Departement Human Nutrition, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509222
- Sponsor's protocol ID
- NL36582.081.11
- Status last verified
- Apr 2013
- First submitted
- 9 Jan 2012
- Last updated
- 25 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Dietary Patterns: an Individually Tailored Nutrition Intervention
- ClinicalTrials.gov ID
- NCT01509222
- Acronym / sponsor ID
- NL36582.081.11
- Conditions
- Obesity
- Keywords
- Health promotion, Dietary Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Giving personalized nutrition advice is perceived to be more effective in changing dietary patterns than giving general information about healthy eating.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized nurition counseling | Other | Behavioral: Personalized nutrition counselingPersonalized nutrition counseling based on dietary intake and motivation to change. |
| Control | No intervention | –No intervention, control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least aged 18 years
- Having one child aged 4 to 12 years
- Written informed concent has been obtained
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized nutrition counseling | Behavioural | Personalized nurition counseling |
Primary outcome
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.
3 secondary outcomes
Dietary behaviour
Time frame: baseline and 6 months
Health outcomes
Time frame: baseline and 6 months
Markers of intake
Time frame: baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne HM De Vries, Dr. principal investigator
Departement Human Nutrition, Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized nutrition counseling in people with Obesity, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in dietary pattern (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2013; AzTrials last refreshed its copy on 3 Nov 2026.