Effectiviteit en Beleving Van FooDIYou

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: Personalized nutritional advice and food boxes; Other: Personalized nutritional advice

• Registration Number: NCT06547983
• Lead Sponsor: TNO

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-25
• Primary Completion: 2023-12-04
• Study Completion: 2023-12-04
• Status Verified: 2024-08
• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention plus group	Personalized nutritional advice and food boxes	-
Intervention group	Personalized nutritional advice	-

Primary Outcome Measures

Name	Time	Method
Body weight in kilograms	6 weeks

Secondary Outcome Measures

Name	Time	Method
BMI as calculated by combining body weight and height (kg/m^2)	6 weeks
Dietary habits as measured using the Nutri+ Module	6 weeks	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.
Opinion on digital intervention as measured using an online questionnaire.	6 weeks	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)
Body height in meters	6 weeks
Hip circumference in centimeters	6 weeks
Waist circumference in centimeters	6 weeks
Neck circumference in centimeters	6 weeks
Wrist circumference in centimeters	6 weeks

Trial Locations

Locations (1)

TNO; 🇳🇱 Leiden, South-Holland, Netherlands