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OpenTrials
Completed

NCT Number: NCT06547983

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TNO

Leiden, South Holland, 2333BE, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized nutritional advice

Other

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

Personalized nutritional advice and food boxes

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.

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

    Time frame: 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.

  8. Opinion on digital intervention as measured using an online questionnaire.

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

TNO

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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