Designing a Mixed-initiative Recipe Recommender App for Vegan and Vegetarian Sub-groups (PERNUG)

The goal of this study is to test the usability and applicability of a mobile application which recommends recipes. We will recruit up to 52 vegan/vegetarian participants in Belgium, and provide them with an iDOO hydroponic plant growing unit (https://www.idooworld.com/products/idoo-20pods-indoor-herb-garden-kit-hydroponics-growing-system-with-led-grow-light) as well as seeds and plant nutrients to grow certain herbs at home. Over a period of 17 weeks, participants will be asked to consume plants from the unit by following the recipes recommended by the app. The participants will then observe changes in their iron and vitamin B12 levels by following up with their GP and report the outcomes back to the researchers at three points during the study (week 0, week 6, and week 17). In addition, the participants will evaluate the usability of the app and the recipes recommended by the app.

Study Overview

• Status: Enrolling by invitation
• Conditions: Mobile Applications
• Intervention / Treatment: Behavioral: Hydroponic unit; Behavioral: Recipes consumption

Detailed Description

Iron is present in plant and animal-derived foods but the fractional absorption of iron from plant foods (that is the percent of iron absorbed from a consumed quantity) is often low (approx 10%) compared to iron from animal sources 25%-30%. It is therefore more challenging for vegans and vegetarians to achieve the Reference Nutrient Intake (RNI) for iron (8.7 mg/day for men over 18 and women over 50, 14.8 mg/day for women aged 18-50), and they are likely to absorb less of that iron and therefore are more likely to become iron depleted.

Plants do not synthesise vitamin B12 and unless fortified, plant-derived foods and beverages do not contain any vitamin B12. the RNI for vitamin B12 in the UK is 1.5 µg/day, therefore it is crucial that vegans and vegetarians take B12 supplements if they don't consume B12-fortified foods or find other ways of incorporating this vitamin into their diets.

Over a period of 17 weeks, participants will be asked to consume plants from the unit by following the recipes recommended by the app. The participants will then observe changes in their iron and vitamin B12 levels by following up with their GP and report the outcomes back to the researchers at three points during the study (week 0, week 6, and week 17). In addition, the participants will evaluate the usability of the app and the recipes recommended by the app.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3001
      • Departement Computerwetenschappen

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria

1. Healthy menstruating female with regular menstruation cycle over 18 years old.
2. Has been vegan, vegetarian or other diets that do not include the consumption of meat and fish for at least 1 year.
3. Willing to remain on a plant-based diet for the duration of the study.
4. Body Mass Index (BMI) between 18.5 - 40 kg/m2.
5. Lives in Belgium.
6. Willing to maintain a hydroponic unit at home and consume plants grown in the hydroponic unit (e.g., parsley, rocket, mizuna).
7. Access to a smartphone or online platform as well as access to the internet.

Exclusion Criteria

1. Those who have known allergies to the hydroponically grown salad greens (parsley, rocket, mizuna).
2. Pescatarian (consumes fish and seafood) and flexitarian (consumes meat intermittently) vegetarian.
3. Those with abnormal menstruation cycle time periods, <21 and >40-day
4. BMI < 18.5 kg/m2 (underweight) and > 40 kg/m2 (severely obese).
5. Those diagnosed or undergoing treatment for anaemia.
6. Currently pregnant or lactating.
7. Diagnosed medical conditions that may impact the study outcomes will be considered on an individual basis.
8. On a, or about to start, a diet programme such as the 5:2 programme (5:2 programme is where an individual would eat normally for five days a week, and fast for two days a week by reducing calorie consumption).
9. Unable to give written or verbal informed consent.
10. Participating in another dietary intervention study nor given blood in another dietary study in the last 3 months.
11. Any person related to or living with any member of the study team.
12. Those who are part of the Line Manager/supervisory structure of the Chief Investigator.
13. Those who have been asked to self-isolate or have been diagnosed with COVID-19 in the last 14 days. However, participants can be rescreened 7 days after the isolation period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary app 1; Dietary app recommends high iron or iron focused recipes	Behavioral: Hydroponic unit; Participants will grow vitamin B12 biofortified plants for 17 weeks and consume (10 grams) of plant material for 11 weeks.; Behavioral: Recipes consumption; Participants will eat one or two recipes a day for 17 weeks
Sham Comparator: Dietary app 2; Dietary app recommends standard iron recipes	Behavioral: Hydroponic unit; Participants will grow vitamin B12 biofortified plants for 17 weeks and consume (10 grams) of plant material for 11 weeks.; Behavioral: Recipes consumption; Participants will eat one or two recipes a day for 17 weeks
Experimental: Hydroponic unit 1; Growing vitamin B12 biofortified plants in a hydroponic unit	Behavioral: Hydroponic unit; Participants will grow vitamin B12 biofortified plants for 17 weeks and consume (10 grams) of plant material for 11 weeks.; Behavioral: Recipes consumption; Participants will eat one or two recipes a day for 17 weeks
No Intervention: Hydroponic unit 2; No hydroponic unit given to participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum ferritin after the dietary app intervention	Comparison of serum ferritin at baseline and after the intervention	Week: 0, 6/7 and 17
Change of serum B12 after the hydroponic unit intervention	Comparison of serum B12 at baseline and after the intervention	Week: 6/7 and 17

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
App usability rating	The usability of the mobile application will be scored on 100 using the System Usability Scale	Week: 6/7 and 17
Score on the Unified Theory of Acceptance and Use of Technology questionnaire	The acceptance of the mobile application will be measured using the Unified Theory of Acceptance and Use of Technology questionnaire on a scale of 1 to 5.	Week: 6/7 and 17
Recipe recommendation performance	The performance of the recipe recommendation system will be measured using the RESQUE questionnaire on a scale of 1 to 5.	Week: 17

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Katrien Verbert, KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: app usage; recipe recommender acceptance
• Other Study ID Numbers: G-2021-4203-R5(AMD)

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