ClinicalTrials.gg
CompletedNCT06547983Updated Aug 12, 2024

Effectiviteit en Beleving Van FooDIYou

An interventional study of Personalized nutritional advice and Personalized nutritional advice and food boxes in Obesity, sponsored by TNO. Completed at 1 site in Netherlands. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by TNO · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Aug 2023, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Obesity

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Keywords

  • Digital studies
  • Personalized nutrition
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 180 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

TNO is the lead sponsor of 32 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 25-60 years
  • 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.

Exclusion criteria

Exclusion Criteria:

  • Any food allergy
  • Chronic diseases influencing food intake (e.g., IBD)
  • Participating in another intervention study
  • Females in menopausal transition
  • Follow a specific diet
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (actual)

Study arms

  • No intervention
    Control group
  • Experimental
    Intervention group

    Other: Personalized nutritional advice

  • Experimental
    Intervention plus group

    Other: Personalized nutritional advice and food boxes

Interventions

  • OtherPersonalized nutritional advice

    Participants in the intervention group received personalized nutrition advice based on their dietary habits, weight, anthropometric data and physical activity.

  • OtherPersonalized nutritional advice and food boxes

    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.

06

What researchers measure

Primary outcomes

  1. Body weight in kilograms

    Time frame: 6 weeks

Secondary outcomes

  1. Body height in meters

    Time frame: 6 weeks

  2. BMI as calculated by combining body weight and height (kg/m^2)

    Time frame: 6 weeks

  3. Hip circumference in centimeters

    Time frame: 6 weeks

  4. Waist circumference in centimeters

    Time frame: 6 weeks

  5. Neck circumference in centimeters

    Time frame: 6 weeks

  6. Wrist circumference in centimeters

    Time frame: 6 weeks

  7. 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.

    Time frame: 6 weeks

  8. 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)

    Time frame: 6 weeks

07

Study locations

1 site
  • TNO
    Leiden, South-Holland 2333BE, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2023 to primary completion in Dec 2023, 3 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 3 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2024
First posted
Aug 12, 2024
StartActual
Aug 25, 2023
Primary completionActual
Dec 4, 2023
CompletionActual
Dec 4, 2023
Last update
Aug 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06547983
Lead sponsor
TNO
Responsible party
Sponsor
First posted
Aug 12, 2024
Start date
Aug 25, 2023
Primary completion
Dec 4, 2023
Completion
Dec 4, 2023
Last update
Aug 12, 2024

Study contacts

Femke Hoevenaars, PhD
principal investigator · TNO

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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