Table 4

Flowchart for adults (A) and children (C) (full sampling at months 0 and 12)

Pre-screeningInformation meetingScreeningBaseline2-month period
(CID1 to CID2)
10-month randomised intervention period
(CID2 to CID4)
1-year assessment
CIDCID1CID2CID3CID4
VisitV0V1V2V3V4V5V6V7V8V9
Month00.51246912
Inclusion/exclusion criteriaA+CA+C
Signing Informed ConsentA+C*
Med. hist., medication etc.A+C
Randomisation of the oldest family/household memberA
Supervision/counsellingA+C†A(+C)‡A+C†A(+C)‡A+C†A(+C)‡A+C†
Collection of LED products
Body weight and height¶A+CA+CA**A**A+CA**A+CA**A+C
Waist and hip circumferenceA+CA+CA+CA+C
Body compositionA+C††AA+C††
Blood pressure and heart rateA+CA+CA+CA+CA+C
Fasting blood samplesA‡‡A+CA+C§§A+CA+C
Adverse events and concomitant medicationA+CA+CA+CA+C
Allergenicity (skin prick test)AA
24 hours urine collection (content of S&SEs)AAA
Faecal spot sampleAAAA
4-day dietary recordA+CA+C
Questionnaires (electronic platforms):
General background questionnaireA+C
Physical activityA+CA+C
Three factor eating questionnaireA+CA+C
Leeds food preference questionnaireA+CA+CA+CA+C
AllergenicityA+CA+C
Craving for sweet tasteAA
Perception of S&SEsAA¶¶A¶¶
Control of eatingAAAA
Subjective appetite sensationsAAAA
Sweet food frequency questionnaire (FFQ)AA
Diet satisfactionAAA
Perception and evaluation of the interventionAA
Quality of lifeAA
PubertyCCC
  • *For children, the informed consent is signed by the parents/guardians.

  • †Individual/family counselling is preferably scheduled at the same day as the CID.

  • ‡Group counselling, children participation is preferred, but not mandatory.

  • §Adults will collect LED products from the intervention site every second or third week during the 2-month period. At months 0.5 and 1.5 (optional), the adults will be weighed and have the opportunity to consult a dietician.

  • ¶Height is only measured at screening for adults.

  • **Fasting is not required for this body weight measurement.

  • ††At University of Maastricht, body composition is not measured in children.

  • ‡‡At screening, fasting blood samples will be analysed at each intervention site. All other blood samples are analysed at the Central Laboratory (Bioiatriki).

  • §§At University of Maastricht, a fasting blood sample is not drawn from children at CID2.

  • ¶¶A shorter version of the questionnaire is used at CID3-4.

  • A, adult; C, child; CID, clinical investigation day; LED, low-energy diet; S&SEs, sweeteners and sweetness enhancers.