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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
- Conditions
- Food Habits, Food, Snack, Acceptance Processes
- 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 group | Role | What they receive |
|---|---|---|
| Reduction | Experimental | Participants will be instructed to reduce all high energy dense snacks that they serve to thier children by 50% Receives: Behavioral: Reduction or Replacement |
| Replacement | Experimental | Participants 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.
Retention
The number of people that adhered to the protocol
Measured: 9 months
Secondary outcomes (9)
Participation
The number of days each participant complied to the snacking schedule
Measured: 9 months
Acceptability
A score derived from a 15 item questionnaire
Measured: 9 months
Preliminary effects of the intervention
Energy intake (kcal)
Measured: 9 months
Preliminary effects of the intervention
Sugar intake (grams)
Measured: 9 months
Preliminary effects of the intervention
Salt intake (grams)
Measured: 9 months
Preliminary effects of the intervention
Fat intake (grams)
Measured: 9 months
Preliminary effects of the intervention
Fruit intake (grams)
Measured: 9 months
Preliminary effects of the intervention
Vegetable intake (grams)
Measured: 9 months
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.
- First posted13 Nov 2017
- Study start1 Dec 2016
- Primary completion12 Aug 2017
- Study completion12 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sophie Reale
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, University of St Andrews
- Responsible party
- Sponsor-investigator, Sophie Reale, University of Sheffield
- Investigators
- Samantha J Caton, PhD, Principal investigator, University of Sheffield
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manipulation of Snack Intake in Young Children Using Snack Replacement and Snack Reduction
- ClinicalTrials.gov ID
- NCT03339986
- Acronym / sponsor ID
- 007850
- Conditions
- Food Habits, Food, Snack, Acceptance Processes
- Keywords
- Portion Size, Feasibility, Acceptability, Snacking, Preschool children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Sophie RealeUniversity, hospital or other
- Collaborators
- University of Leeds, University of St Andrews
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 12 Aug 2017 (actual)
- Study completion
- 12 Aug 2017 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduction | Experimental | Behavioral: Reduction or ReplacementParticipants will be instructed to reduce all high energy dense snacks that they serve to thier children by 50% |
| Replacement | Experimental | Behavioral: Reduction or ReplacementParticipants will be instructed to replace all high energy dense snacks with fresh fruit and vegetables |
Who may qualify
- Ages
- 24 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduction or Replacement | Behavioural | Reduction, Replacement |
Primary outcome
Retention
Time frame: 9 months
The number of people that adhered to the protocol
9 secondary outcomes
Participation
Time frame: 9 months
Acceptability
Time frame: 9 months
Preliminary effects of the intervention
Time frame: 9 months
Preliminary effects of the intervention
Time frame: 9 months
Preliminary effects of the intervention
Time frame: 9 months
Preliminary effects of the intervention
Time frame: 9 months
Preliminary effects of the intervention
Time frame: 9 months
Preliminary effects of the intervention
Time frame: 9 months
Sustainability of effect
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Food Habits
Recruiting
The Florida ASCENT Study
Cancer, Food Deprivation
Recruiting
Integrating Food Rx With Best Feeding Practices With EFNEP
Dietary Habits, Childhood Obesity
RecruitingObservational study
Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico
Heart Diseases, Type2 Diabetes
Not yet recruiting
Food Literacy Intervention - is a "Train the Trainer" Approach Feasible and Effective?
Lifestyle Risk Reduction, Health Behavior
Recruiting
Maximizing Nutrition Education to Meet Dietary and Food Security of Children and Parents
Nutrition, Healthy, Hunger
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha J Caton, PhD principal investigator
University of Sheffield
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.