Effectiviteit en Beleving Van FooDIYou

NCT ID: NCT06547983

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-25

Study Completion Date

2023-12-04

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

Group Type EXPERIMENTAL

Personalized nutritional advice

Intervention Type OTHER

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

Intervention plus group

Group Type EXPERIMENTAL

Personalized nutritional advice and food boxes

Intervention Type OTHER

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.

Interventions

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Personalized nutritional advice

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TNO

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Femke Hoevenaars, PhD

Role: PRINCIPAL_INVESTIGATOR

TNO

Locations

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TNO

Leiden, South Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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#2023-083

Identifier Type: -

Identifier Source: org_study_id

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