ObesityNCT06547983
Effectiviteit en Beleving Van FooDIYou
A study testing Personalized nutritional advice and Personalized nutritional advice and food boxes in people with Obesity, run by TNO at 1 site in Netherlands.
Trial summary
Studies have shown that personalized nutrition advice is more effective compared to generic nutrition advice for weight loss purposes. However, since decentralization of clinical trials is on the rise, it of interest to test whether personalized nutrition advice is as effective when provided fully digitally. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Personalized nutritional advice and Personalized nutritional advice and food boxes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Aug 2023to 4 Dec 2023
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 25-60 years
- BMI between 25 and 40
- Motivated to lose weight
- Can fill in a digital questionnaire
- Posses a smartphone, computer, weighing scale and measuring tape to perform anthropometric measurements.
Who cannot join
- Any food allergy
- Chronic diseases influencing food intake (e.g., IBD)
- Participating in another intervention study
- Females in menopausal transition
- Follow a specific diet
Trial locations and contacts
1 site in 1 country.
About this study
Studies have shown that personalized nutrition advice is more effective compared to generic nutrition advice for weight loss purposes. However, since decentralization of clinical trials is on the rise, it of interest to test whether personalized nutrition advice is as effective when provided fully digitally. In the current study the investigators compare the effects of generic vs. personal nutritional interventions in a fully digital study. Three groups are included, a control group receiving generic nutritional advice, an intervention group receiving personalized nutrition advice and an intervention plus group receiving personalized nutrition advice plus personalized meals. The trial takes six weeks. Anthropometric data are collected every two weeks and data on changes in nutritional diet are collected at the beginning and end of the intervention. In addition, the opinion of the participants on trial participation is asked as well every two weeks during the trial.
- Conditions
- Obesity
- Being tested
- Personalized nutritional advice, Personalized nutritional advice and food boxes
- Keywords
- Digital studies, Personalized nutrition
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized nutritional adviceOther
Participants in the intervention group received personalized nutrition advice based on their dietary habits, weight, anthropometric data and physical activity.
Personalized nutritional advice and food boxesOther
Participants in the intervention plus group received the personalized nutrition advice while also receiving food boxes which are composed based on the personalized nutritional advice.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Intervention group | Experimental | Not described Receives: Other: Personalized nutritional advice |
| Intervention plus group | Experimental | Not described Receives: Other: Personalized nutritional advice and food boxes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight in kilograms
Measured: 6 weeks
Secondary outcomes (8)
Body height in meters
Measured: 6 weeks
BMI as calculated by combining body weight and height (kg/m^2)
Measured: 6 weeks
Hip circumference in centimeters
Measured: 6 weeks
Waist circumference in centimeters
Measured: 6 weeks
Neck circumference in centimeters
Measured: 6 weeks
Wrist circumference in centimeters
Measured: 6 weeks
Dietary habits as measured using the Nutri+ Module
Nutri+ Module is a food frequency questionnaire developed by TNO (TNO, Leiden, The Netherlands). This is used to obtain information on the habitual total food intake by asking food category consumption over the day.
Measured: 6 weeks
Opinion on digital intervention as measured using an online questionnaire.
The online questionnaire contained the following questions and multiple choice answers:
- How easily can the participant implement the nutritional advice? (very easily/easily/moderately/poorly/very poorly)
- How pleasant is it to implement the nutritional advice? (very pleasant, pleasant, moderate, unpleasant, very unpleasant)
- Did participant's diet change compared to before the intervention? (Yes/no)
- Does the participant feel like the participant's diet is healthier compared to before the intervention? (Yes/no)
- How easily can the participant perform the anthropometric measurements by themselves? (very easily/easily/moderately/poorly/very poorly)
- Are the questions in the questionnaire clear? (yes/no)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start25 Aug 2023
- Primary completion4 Dec 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Femke Hoevenaars, PhD, Principal investigator, TNO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547983
- Sponsor's protocol ID
- #2023-083
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Jong JC, Hoevenaars FP, Peters LG, Berendsen CM, Pasman WJ, Caspers MP, Dulos R, Wopereis S. A Real-Life Digital Intervention for Personalized Nutrition in Adults With Overweight or Obesity: Remote Randomized Controlled Trial. J Med Internet Res. 2026 Jan 5;28:e73367. doi: 10.2196/73367.
PubMed 41490780
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiviteit en Beleving Van FooDIYou
- ClinicalTrials.gov ID
- NCT06547983
- Acronym / sponsor ID
- #2023-083
- Conditions
- Obesity
- Keywords
- Digital studies, Personalized nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- TNOUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 12 Aug 2024 (actual)
- 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.
Studies have shown that personalized nutrition advice is more effective compared to generic nutrition advice for weight loss purposes. However, since decentralization of clinical trials is on the rise, it of interest to test whether personalized nutrition advice is as effective when provided fully digitally. In the current study the investigators compare the effects of generic vs. personal nutritional interventions in a fully digital study. Three groups are included, a control group receiving generic nutritional advice, an intervention group receiving personalized nutrition advice and an intervention plus group receiving personalized nutrition advice plus personalized meals. The trial takes six weeks. Anthropometric data are collected every two weeks and data on changes in nutritional diet are collected at the beginning and end of the intervention. In addition, the opinion of the participants on trial participation is asked as well every two weeks during the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Intervention group | Experimental | Other: Personalized nutritional advice |
| Intervention plus group | Experimental | Other: Personalized nutritional advice and food boxes |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 25-60 years
- BMI between 25 and 40
- Motivated to lose weight
- Can fill in a digital questionnaire
- Posses a smartphone, computer, weighing scale and measuring tape to perform anthropometric measurements.
Key exclusion criteria (5 listed)
- Any food allergy
- Chronic diseases influencing food intake (e.g., IBD)
- Participating in another intervention study
- Females in menopausal transition
- Follow a specific diet
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 nutritional adviceParticipants in the intervention group received personalized nutrition advice based on their dietary habits, weight, anthropometric data and physical activity. | Other | Intervention group |
| Personalized nutritional advice and food boxesParticipants in the intervention plus group received the personalized nutrition advice while also receiving food boxes which are composed based on the personalized nutritional advice. | Other | Intervention plus group |
Primary outcome
Body weight in kilograms
Time frame: 6 weeks
8 secondary outcomes
Body height in meters
Time frame: 6 weeks
BMI as calculated by combining body weight and height (kg/m^2)
Time frame: 6 weeks
Hip circumference in centimeters
Time frame: 6 weeks
Waist circumference in centimeters
Time frame: 6 weeks
Neck circumference in centimeters
Time frame: 6 weeks
Wrist circumference in centimeters
Time frame: 6 weeks
Dietary habits as measured using the Nutri+ Module
Time frame: 6 weeks
Opinion on digital intervention as measured using an online questionnaire.
Time frame: 6 weeks
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 12 Aug 2024.
- Derived from this study: PubMed 41490780de Jong JC, Hoevenaars FP, Peters LG, Berendsen CM, Pasman WJ, Caspers MP, Dulos R, Wopereis S. A Real-Life Digital Intervention for Personalized Nutrition in Adults With Overweight or Obesity: Remote Randomized Controlled Trial. J Med Internet Res. 2026 Jan 5;28:e73367. doi: 10.2196/73367.
- Individual participant dataSharing planned: No
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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.
Femke Hoevenaars, PhD principal investigator
TNO
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 nutritional advice and Personalized nutritional advice and food boxes in people with Obesity, run by TNO 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 5 inclusion and 5 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 12 Aug 2024. 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?
Body weight in kilograms (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06547983, which also lists 1 linked publication.
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 12 Aug 2024.