Energy IntakeNCT02207049
The Effect of Snack Consumption on Energy Intake in Preschoolers
A study testing Snacking and No Snacking in people with Energy Intake and Snacks, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
The purpose of this pilot study will be to examine the influence of providing snacks on consumption of overall energy intake in children aged 2-5 years in the Early Learning Center (ELC) at the University of Tennessee. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Intake, Snacks, Children, Preschool
- What is being tested?
- Snacking and No Snacking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 31 Dec 2025
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3 -to- 5 years of age
- enrolled at the Early Learning Center for the full day program
- have guardian consent to participate
- like the foods served
Who cannot join
- have allergies or intolerances to the foods being served
- not able to use a spoon
- did not attend all feeding sessions
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Activity Laboratory
Knoxville, Tennessee, 37996
About this study
The purpose of this pilot study will be to examine the influence of providing snacks on consumption of overall energy intake in children aged 2-5 years in the Early Learning Center (ELC) at the University of Tennessee.
Read the detailed description
Providing snacks to children is widely recommended for appetite regulation and assisting with meeting nutritional guidelines.1 Currently, snacks contribute a larger portion of dietary intake in children than in previous years.2,3 Additionally, observational research has found that self-reported, low-nutrient-dense snack consumption, has increased among preschoolers (ages 2-to-6 years) over the past 20 years, leading to an increase of total daily energy intake.3 However, no experimental studies examining the influence of snack intake on energy consumption in children have been conducted.2 Therefore, at this time it is not clear how snacks impact appetite regulation or energy intake, especially in young children.
Thus, the purpose of this pilot study will be to examine the influence of providing snacks on consumption of overall energy intake in children aged 2-5 years in the Early Learning Center (ELC) at the University of Tennessee. Children will be provided with 3-to-5 ad libitum eating occasions over the course of a day for three sessions. To test the effects of providing snacks to preschoolers on consumption of food throughout the day, the food will be provided in three ways in the three different sessions: 1) children will be provided three meals (TM); 2) children will be provided three meals and two snacks, with total amount of food provided in the day the same as TM (M+S); and 3) children will be provided three meals and two snacks with total amount provided in the meals equal to TM and total amount provided in the snacks equal to M+S (TM+S).
Primary Hypothesis:
- Energy consumed from food and beverages will be greatest during the TM+S session, followed by M+S, and then TM.
- Conditions
- Energy Intake, Snacks, Children, Preschool
- Being tested
- Snacking, No Snacking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SnackingBehavioural
Snacks will be provided to preschoolers, either as part of total caloric needs or above total caloric needs
No SnackingBehavioural
Caloric needs will be provided to preschoolers within three meals
| Study group | Role | What they receive |
|---|---|---|
| Three Meals (TM) | Active comparator | Preschoolers will be provided their caloric needs within three meals. Receives: Behavioral: No Snacking |
| Meal plus Snack (M+S) | Active comparator | Preschoolers will be provided three meals and two snacks, with total amount of food provided in the day the same as the Three Meal (TM) arm. Receives: Behavioral: Snacking |
| Three Meal plus Snack (TM+S) | Active comparator | Preschoolers will be provided three meals and two snacks with total amount provided in the meals equal to the Three Meal (TM) arm and total amount provided in the snacks equal to Meal plus Snacks (M+S) arm. Receives: Behavioral: Snacking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total calories of the food and beverages consumed.
Total calories of food and beverage consumed by participants over the 3-week study (with 1 day of food and beverage per week) period will be determined by subtracting pre- and post-consumption weight of the food and beverage provided and multiplied by the energy density of each respective food and beverage.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startSep 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Energy IntakeStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Hollie A Raynor, PhD, RD, LDN, Principal investigator, University of Tennesseem Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207049
- Sponsor's protocol ID
- 9564 B
- Status last verified
- Jun 2026
- First submitted
- 30 Jul 2014
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Allen RE, Myers AL. Nutrition in toddlers. Am Fam Physician. 2006 Nov 1;74(9):1527-32.
PubMed 17111891Smith-Petersen MN, Larson CB, Cochran W. Local chemotherapy with primary closure of septic wounds by means of drainage and irrigation cannulae : M. N. Smith-Petersen MD (1886-1953), Carroll B. Larson MD, Williams Cochran MD . The 12th president of the AAOS 1943 (MNS-P). Clin Orthop Relat Res. 2008 Jan;466(1):104-12. doi: 10.1007/s11999-007-0023-4.
PubMed 18196379Ford CN, Slining MM, Popkin BM. Trends in dietary intake among US 2- to 6-year-old children, 1989-2008. J Acad Nutr Diet. 2013 Jan;113(1):35-42. doi: 10.1016/j.jand.2012.08.022.
PubMed 23260722
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Snack Consumption on Energy Intake in Preschoolers
- ClinicalTrials.gov ID
- NCT02207049
- Acronym / sponsor ID
- 9564 B
- Conditions
- Energy Intake, Snacks, Children, Preschool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 1 Aug 2014 (estimated)
- 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 purpose of this pilot study will be to examine the influence of providing snacks on consumption of overall energy intake in children aged 2-5 years in the Early Learning Center (ELC) at the University of Tennessee.
Detailed description
Providing snacks to children is widely recommended for appetite regulation and assisting with meeting nutritional guidelines.1 Currently, snacks contribute a larger portion of dietary intake in children than in previous years.2,3 Additionally, observational research has found that self-reported, low-nutrient-dense snack consumption, has increased among preschoolers (ages 2-to-6 years) over the past 20 years, leading to an increase of total daily energy intake.3 However, no experimental studies examining the influence of snack intake on energy consumption in children have been conducted.2 Therefore, at this time it is not clear how snacks impact appetite regulation or energy intake, especially in young children.
Thus, the purpose of this pilot study will be to examine the influence of providing snacks on consumption of overall energy intake in children aged 2-5 years in the Early Learning Center (ELC) at the University of Tennessee. Children will be provided with 3-to-5 ad libitum eating occasions over the course of a day for three sessions. To test the effects of providing snacks to preschoolers on consumption of food throughout the day, the food will be provided in three ways in the three different sessions: 1) children will be provided three meals (TM); 2) children will be provided three meals and two snacks, with total amount of food provided in the day the same as TM (M+S); and 3) children will be provided three meals and two snacks with total amount provided in the meals equal to TM and total amount provided in the snacks equal to M+S (TM+S).
Primary Hypothesis:
- Energy consumed from food and beverages will be greatest during the TM+S session, followed by M+S, and then TM.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Three Meals (TM) | Active comparator | Behavioral: No SnackingPreschoolers will be provided their caloric needs within three meals. |
| Meal plus Snack (M+S) | Active comparator | Behavioral: SnackingPreschoolers will be provided three meals and two snacks, with total amount of food provided in the day the same as the Three Meal (TM) arm. |
| Three Meal plus Snack (TM+S) | Active comparator | Behavioral: SnackingPreschoolers will be provided three meals and two snacks with total amount provided in the meals equal to the Three Meal (TM) arm and total amount provided in the snacks equal to Meal plus Snacks (M+S) arm. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 3 -to- 5 years of age
- enrolled at the Early Learning Center for the full day program
- have guardian consent to participate
- like the foods served
Key exclusion criteria (3 listed)
- have allergies or intolerances to the foods being served
- not able to use a spoon
- did not attend all feeding sessions
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 |
|---|---|---|
| SnackingSnacks will be provided to preschoolers, either as part of total caloric needs or above total caloric needs | Behavioural | Meal plus Snack (M+S), Three Meal plus Snack (TM+S) |
| No SnackingCaloric needs will be provided to preschoolers within three meals | Behavioural | Three Meals (TM) |
Primary outcome
Total calories of the food and beverages consumed.
Time frame: 3 weeks
Total calories of food and beverage consumed by participants over the 3-week study (with 1 day of food and beverage per week) period will be determined by subtracting pre- and post-consumption weight of the food and beverage provided and multiplied by the energy density of each respective food and beverage.
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 9 Jun 2026.
- Background: PubMed 17111891Allen RE, Myers AL. Nutrition in toddlers. Am Fam Physician. 2006 Nov 1;74(9):1527-32.
- Background: PubMed 18196379Smith-Petersen MN, Larson CB, Cochran W. Local chemotherapy with primary closure of septic wounds by means of drainage and irrigation cannulae : M. N. Smith-Petersen MD (1886-1953), Carroll B. Larson MD, Williams Cochran MD . The 12th president of the AAOS 1943 (MNS-P). Clin Orthop Relat Res. 2008 Jan;466(1):104-12. doi: 10.1007/s11999-007-0023-4.
- Background: PubMed 23260722Ford CN, Slining MM, Popkin BM. Trends in dietary intake among US 2- to 6-year-old children, 1989-2008. J Acad Nutr Diet. 2013 Jan;113(1):35-42. doi: 10.1016/j.jand.2012.08.022.
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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.
Hollie A Raynor, PhD, RD, LDN principal investigator
University of Tennesseem Knoxville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snacking and No Snacking in people with Energy Intake and Snacks, run by The University of Tennessee, Knoxville at 1 site in United States.
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 4 inclusion and 3 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 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Total calories of the food and beverages consumed. (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02207049, which also lists 3 linked publications.
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 9 Jun 2026.