Obesity
Conditions
Keywords
Digital studies, Personalized nutrition
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.
Interventions
OTHERPersonalized nutritional advice
Participants in the intervention group received personalized nutrition advice based on their dietary habits, weight, anthropometric data and physical activity.
OTHERPersonalized 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.
Sponsors
TNO
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight in kilograms | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Body height in meters | 6 weeks | — |
| Wrist circumference in centimeters | 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) |
| Neck circumference in centimeters | 6 weeks | — |
Countries
Netherlands
Outcome results
None listed