Food Habits Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03277040 -
Diet, Eating, and Lifestyle Improvement for Valued Employees and Their Relatives
|
N/A | |
Not yet recruiting |
NCT03266666 -
Welcome to WellnessRX: Steps Toward a Healthier Life!
|
N/A | |
Recruiting |
NCT02902926 -
Comparison of Microbiota and Quality of Life for a Low FODMAPs and Standard Dietary in Irritable Bowel Syndrome Patients
|
N/A | |
Completed |
NCT03003923 -
Promoting Vegetable Intake in Preschool Aged Children
|
N/A | |
Completed |
NCT02309840 -
The Modifying Eating and Lifestyles at School Study
|
N/A | |
Completed |
NCT02729675 -
Innovative Approaches to Increase F&V Intake Thru Worksites
|
Phase 2 | |
Completed |
NCT00360919 -
Assessing the Presence of Casomorphins in Human Plasma After Dairy Ingestion
|
Phase 0 | |
Completed |
NCT01156805 -
Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study
|
N/A | |
Not yet recruiting |
NCT06258733 -
Food Literacy Intervention - is a "Train the Trainer" Approach Feasible and Effective?
|
N/A | |
Not yet recruiting |
NCT04493944 -
Edible Seaweeds and Health: Quality Biomarkers to Support Consumer Acceptance
|
N/A | |
Completed |
NCT04115852 -
Interoceptive Nutritional Processing in Healthy Participants and Patients With Binge-Eating-Disorder
|
||
Completed |
NCT03340363 -
"Make It Fresh, For Less" Supermarket Pilot Study
|
N/A | |
Withdrawn |
NCT05073562 -
Nutrition Intervention to Address Anemia Among Adolescent Girls in Liberia
|
N/A | |
Completed |
NCT03941392 -
Nutritional Study in Spanish Pediatric Population
|
||
Completed |
NCT03400566 -
Effects of Experiential Learning on Vegetable Intake in Preschool Children
|
N/A | |
Active, not recruiting |
NCT04262102 -
The Dastatuz Project
|
N/A | |
Recruiting |
NCT05773677 -
Diet in Twin Pregnancy: the Wellness of Mother and Babies.
|
N/A | |
Terminated |
NCT03283033 -
School Lunch Salad Bars and Fruit and Vegetable Consumption
|
N/A | |
Completed |
NCT03251664 -
Food Groups Associated With Anaemia in Pregnant Women
|
N/A | |
Completed |
NCT04586647 -
Attitudes Toward Food During a Weight Loss Intervention
|
N/A |