Effectiviteit en Beleving Van FooDIYou

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 Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Personalized nutritional advice; Other: Personalized nutritional advice and food boxes

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • South-Holland
    • Leiden, South-Holland, Netherlands, 2333BE
      • TNO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group	Other: Personalized nutritional advice; Participants in the intervention group received personalized nutrition advice based on their dietary habits, weight, anthropometric data and physical activity.
Experimental: Intervention plus group	Other: Personalized 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body weight in kilograms	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body height in meters		6 weeks
BMI as calculated by combining body weight and height (kg/m^2)		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
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.	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)	6 weeks

Collaborators and Investigators

• Sponsor: TNO
• Investigators: Principal Investigator: Femke Hoevenaars, PhD, TNO

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Actual): December 4, 2023
• Study Completion (Actual): December 4, 2023

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Personalized nutrition; Digital studies
• Other Study ID Numbers: #2023-083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No