NCT06547983

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

August 2, 2024

Last Update Submit

August 7, 2024

Conditions

Obesity

Keywords

Digital studiesPersonalized nutrition

Outcome Measures

Primary Outcomes (1)

  • Body weight in kilograms

    6 weeks

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (3)

Control group

NO INTERVENTION

Intervention group

EXPERIMENTAL
Other: Personalized nutritional advice

Intervention plus group

EXPERIMENTAL
Other: Personalized nutritional advice and food boxes

Interventions

Personalized nutritional adviceOTHER

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

Intervention group
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.

Intervention plus group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TNO

Leiden, South Holland, 2333BE, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 41490780DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Femke Hoevenaars, PhD

    TNO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 12, 2024

Study Start

August 25, 2023

Primary Completion

December 4, 2023

Study Completion

December 4, 2023

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)