Downsizing: Snacking in Preschool Children

NCT03339986 | Completed

• 1 other identifier: 007850
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Food Habits; Food, Snack; Acceptance Processes

Keywords

Portion Size; Feasibility; Acceptability; Snacking; Preschool children

Outcome Measures

Primary Outcomes (1)

• Retention

  The number of people that adhered to the protocol

  9 months

Secondary Outcomes (9)

• Participation

  9 months

• Acceptability

  9 months

• Preliminary effects of the intervention

  9 months

• Preliminary effects of the intervention

  9 months

• Preliminary effects of the intervention

  9 months

Study Arms (2)

Reduction

EXPERIMENTAL

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

Behavioral: Reduction or Replacement

Replacement

EXPERIMENTAL

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

Behavioral: Reduction or Replacement

Interventions

Reduction or Replacement BEHAVIORAL

Reduction; Replacement

Eligibility Criteria

• Age: 24 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sophie Reale: lead
• University of Leeds: collaborator
• University of St Andrews: collaborator

MeSH Terms

Conditions

Feeding Behavior; Behavior

Interventions

Replantation

Condition Hierarchy (Ancestors)

Behavior, Animal

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Samantha J Caton, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: November 13, 2017
• Study Start: December 1, 2016
• Primary Completion: August 12, 2017
• Study Completion: August 12, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share