ClinicalTrials.gg
CompletedNCT03339986Updated Nov 13, 2017

Downsizing: Snacking in Preschool Children

An interventional study of Reduction or Replacement in Food Habits, Food, Snack and Acceptance Processes, sponsored by Sophie Reale. Completed. Open to participants aged 24 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-13.

Sponsored by Sophie Reale · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Dec 2016, registered Aug 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
24 Months to 59 Months
Sex
All
01

Study summary

The aim of the study is to investigate and compare two strategies of portion control in toddlers aged 24 to 59 months (snack replacement and snack reduction). The investigators aim to compare the effect of these strategies on habitual dietary intake (total energy intake (kcal), sugar intake (g), intake of fruits and vegetables, and intake at a test meal provided in the home (total energy intake (kcal) and intake of each component of the meal, e.g. intake of vegetables). Outcome measures will be compared to baseline within strategies and also between strategies to explore which portion control strategy might be most effective.

Read the detailed description

Following provision of informed consent the primary caregiver will be provided with a recruitment questionnaire. The questionnaire can be completed on paper or online (identical questionnaires). It will include the Food Frequency Questionnaire (FFQ; Hammond et al., 1993) to determine whether the child likes and regularly eats HED snacks. A FFQ will also be administered to the main caregiver in order to establish familial patterns of food intake.

Demographic information will be collected for both caregivers and child in paper or online format. Measures of child eating behaviour, parental feeding practices, food neophobia and temperament will be taken. Anthropometric information of the child will also be collected by the researcher to calculate weight-for-height z scores.

A between-subject 3-week intervention will be implemented with participants acting as their own controls during the baseline (week 1) and acclimation (week 2) periods before being randomised in to the intervention period (week 3) (figure 1). Caregivers will be instructed to complete a 4-day weighed food diary each week (3 weekdays and at least one weekend day). This will involve the caregiver recording all food and drinks consumed by their child to the nearest gram using the scales provided.

During week 1 (baseline) parents will be instructed to make no alterations to the foods and drinks that they provide to their child. Data from this phase of the experiment will be used to examine the habitual diet. Data obtained in this phase will enable us to determine whether or not the provision of the snacks has changed the child's dietary habits.

During week 2 (acclimation phase) participants will be provided with a range of snacks that are intended to replace all usual snacks. This will consist of several different snack options (figure 2) to provide up to three snacks per day and to allow for any siblings who may want an identical snack option. All participants will be provided with the same selection of HED snacks, which will be familiar to all children. Snack types and amounts will be based on data collected from the cohort prior to the beginning of the experiment when participants express an interest in taking part. Parents/ caregivers will be required to replace all usual snacks with the ones provided over the following 7 days and will be instructed to provide the snacks at their child's usual snack time following a snacking schedule, and to record it in the food diary; this will allow the snacking schedule to be matched in week three. If parents usually provide fruit or vegetables (in their natural form) for a snack occasion they will be instructed to continue to do so. HED snacks are being provided in this pilot study to ensure consistency across all children.

In week 3 parents will be randomly allocated (block randomisation) to one of two portion size reduction interventions via simple randomisation procedure (snack reduction or snack replacement). Caregivers will be instructed to either reduce all snacks by 50% or replace all snacks with familiar and relatively liked fruits, vegetables and a starch component (breadstick, cracker or rice cake). In the snack reduction condition parents and caregivers will be provided with the same snacks as in week 2 and a snacking schedule showing the amounts and types of snacks that should be offered to the child (as per week 2). Once the downsized snack (50% portion) has been consumed, if the child indicates that they are still hungry, caregivers will be advised to offer any other low energy dense foods such as fruits and vegetables. In the replacement condition, caregivers will be instructed to remove all HED snacks that were provided in week 2 or otherwise and sugar sweetened beverages from the child's diet for one week and offer only the fruits and vegetables, starch-based food (bread stick, rice cake or cracker) and sugar free drinks provided. All participants in the snack replacement group will be provided with a snack pack consisting of fruits and vegetables familiar and relatively liked to all children (for example apples, grapes, pears, banana, red pepper, cucumber, cherry tomatoes and carrots (all served raw)). The fruit and vegetable types will be based on the data collected on children familiarity of fruits and vegetables from the cohort prior to week 1.Caregivers will be instructed to offer 40g of both a specified fruit and vegetable (more if the child requests) and a pre-defined starch component. This is based on a typical portion size for a pre-school child. A snacking schedule will also be provided for the fruits and vegetables.

02

Conditions studied

  • Food Habits
  • Food, Snack
  • Acceptance Processes

Keywords

  • Portion Size
  • Feasibility
  • Acceptability
  • Snacking
  • Preschool children
03

In context

Feeding Behavior

985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.

This study's enrollment of 46 is below the median of 77 across 700 interventional studies indexed under Feeding Behavior.

Browse Feeding Behavior studies →

Lead sponsor

This is the only study on the registry with Sophie Reale as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Parents/ caregivers of children aged 24-59 months old
  • Must consume a HED snack at least once per day.
  • Written provided from caregivers/ parents.

Exclusion criteria

Exclusion Criteria:

  • Children who attend nursery for more than three full consecutive days will be excluded due to the requirement of a four-day consecutive food diary to be completed in the home environment.
  • Children with food allergies, long-term health conditions known to affect food intake, who are taking medication known to affect appetite, and those who report dislike of the snacks provided will be excluded from taking part.
  • Children whose parents report a dislike of the study foods will also be excluded from taking part in the study.
  • Children whose parents report no commercially available snack intake will be excluded from taking part in the study since participants will be required to reduce their children's snack intake by 50% or replace it with a LED alternative. At least one high energy dense, commercially available snack (e.g. chocolate, crisps) must normally be consumed per day by the child
  • Parent child pairs must be able to commit to three consecutive weeks in order to take part in the study.
  • Participant who are excluded from taking part in the current study will be invited to take part in our future studies where no study food will be provided.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Reduction

    Participants will be instructed to reduce all high energy dense snacks that they serve to thier children by 50%

    Behavioral: Reduction or Replacement

  • Experimental
    Replacement

    Participants will be instructed to replace all high energy dense snacks with fresh fruit and vegetables

    Behavioral: Reduction or Replacement

Interventions

  • BehavioralReduction or Replacement
06

What researchers measure

Primary outcomes

  1. Retention

    The number of people that adhered to the protocol

    Time frame: 9 months

Secondary outcomes

  1. Participation

    The number of days each participant complied to the snacking schedule

    Time frame: 9 months

  2. Acceptability

    A score derived from a 15 item questionnaire

    Time frame: 9 months

  3. Preliminary effects of the intervention

    Energy intake (kcal)

    Time frame: 9 months

  4. Preliminary effects of the intervention

    Sugar intake (grams)

    Time frame: 9 months

  5. Preliminary effects of the intervention

    Salt intake (grams)

    Time frame: 9 months

  6. Preliminary effects of the intervention

    Fat intake (grams)

    Time frame: 9 months

  7. Preliminary effects of the intervention

    Fruit intake (grams)

    Time frame: 9 months

  8. Preliminary effects of the intervention

    Vegetable intake (grams)

    Time frame: 9 months

  9. Sustainability of effect

    Frequency of consumption (FFQ)

    Time frame: 9 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03339986
Lead sponsor
Sophie Reale
Collaborators
University of Leeds, University of St Andrews
Responsible party
Sophie Reale (PhD student, University of Sheffield) — Sponsor-investigator
First posted
Nov 13, 2017
Start date
Dec 1, 2016
Primary completion
Aug 12, 2017
Completion
Aug 12, 2017
Last update
Nov 13, 2017

Study contacts

Samantha J Caton, PhD
principal investigator · University of Sheffield

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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