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Downsizing: Snacking in Preschool Children

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ClinicalTrials.gov Identifier: NCT03339986
Recruitment Status : Completed
First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Collaborators:
University of Leeds
University of St Andrews
Information provided by (Responsible Party):
Sophie Reale, University of Sheffield

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.

Condition or disease Intervention/treatment Phase
Food Habits Food, Snack Acceptance Processes Behavioral: Reduction or Replacement Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Manipulation of Snack Intake in Young Children Using Snack Replacement and Snack Reduction
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : August 12, 2017
Actual Study Completion Date : August 12, 2017

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Retention [ Time Frame: 9 months ]
    The number of people that adhered to the protocol


Secondary Outcome Measures :
  1. Participation [ Time Frame: 9 months ]
    The number of days each participant complied to the snacking schedule

  2. Acceptability [ Time Frame: 9 months ]
    A score derived from a 15 item questionnaire

  3. Preliminary effects of the intervention [ Time Frame: 9 months ]
    Energy intake (kcal)

  4. Preliminary effects of the intervention [ Time Frame: 9 months ]
    Sugar intake (grams)

  5. Preliminary effects of the intervention [ Time Frame: 9 months ]
    Salt intake (grams)

  6. Preliminary effects of the intervention [ Time Frame: 9 months ]
    Fat intake (grams)

  7. Preliminary effects of the intervention [ Time Frame: 9 months ]
    Fruit intake (grams)

  8. Preliminary effects of the intervention [ Time Frame: 9 months ]
    Vegetable intake (grams)

  9. Sustainability of effect [ Time Frame: 9 months ]
    Frequency of consumption (FFQ)



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Ages Eligible for Study:   24 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339986


Sponsors and Collaborators
Sophie Reale
University of Leeds
University of St Andrews
Investigators
Principal Investigator: Samantha J Caton, PhD University of Sheffield

Responsible Party: Sophie Reale, PhD student, University of Sheffield
ClinicalTrials.gov Identifier: NCT03339986     History of Changes
Other Study ID Numbers: 007850
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sophie Reale, University of Sheffield:
Portion Size
Feasibility
Acceptability
Snacking
Preschool children