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Food HabitsNCT03339986

Downsizing: Snacking in Preschool Children

A study testing Reduction or Replacement in people with Food Habits and Food, Snack, run by Sophie Reale.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 24 to 59 monthsHealthy volunteers can take part
Conditions the study is for
Food Habits, Food, Snack, Acceptance Processes
What is being tested?
Reduction or Replacement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
No sites listed yet
Study dates
1 Dec 2016to 12 Aug 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 59 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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.

About this study

Official title: Manipulation of Snack Intake in Young Children Using Snack Replacement and Snack Reduction

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.

Being tested
Reduction or Replacement
Keywords
Portion Size, Feasibility, Acceptability, Snacking, Preschool children
Medical subject headings
Feeding Behavior, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reduction or ReplacementBehavioural

Study groups in NCT03339986
Study groupRoleWhat they receive
ReductionExperimentalParticipants will be instructed to reduce all high energy dense snacks that they serve to thier children by 50%
Receives: Behavioral: Reduction or Replacement
ReplacementExperimentalParticipants will be instructed to replace all high energy dense snacks with fresh fruit and vegetables
Receives: Behavioral: Reduction or Replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention

    The number of people that adhered to the protocol

    Measured: 9 months

Secondary outcomes (9)
  1. Participation

    The number of days each participant complied to the snacking schedule

    Measured: 9 months

  2. Acceptability

    A score derived from a 15 item questionnaire

    Measured: 9 months

  3. Preliminary effects of the intervention

    Energy intake (kcal)

    Measured: 9 months

  4. Preliminary effects of the intervention

    Sugar intake (grams)

    Measured: 9 months

  5. Preliminary effects of the intervention

    Salt intake (grams)

    Measured: 9 months

  6. Preliminary effects of the intervention

    Fat intake (grams)

    Measured: 9 months

  7. Preliminary effects of the intervention

    Fruit intake (grams)

    Measured: 9 months

  8. Preliminary effects of the intervention

    Vegetable intake (grams)

    Measured: 9 months

  9. Sustainability of effect

    Frequency of consumption (FFQ)

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2017
  2. Study start1 Dec 2016
  3. Primary completion12 Aug 2017
  4. Study completion12 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03339986
Sponsor's protocol ID
007850
Status last verified
Nov 2017
First submitted
23 Aug 2017
Last updated
13 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Reduction or Replacement in people with Food Habits and Food, Snack, run by Sophie Reale.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017; AzTrials last refreshed its copy on 29 Oct 2026.

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