SnackingNCT03940105
The Effects of Snack Size and Variety on Appetite Control, Satiety, and Eating Behavior in Healthy Adults.
A study testing Packout in people with Snacking, run by Purdue University at 1 site in United States.
Trial summary
The investigators propose a randomized snack study in normal to obese adults that will test whether snack size, choice, or variety has an influence on daily snack intake. Aim 1: To validate the in-house packout methodology with 3-day dietary recalls. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Snacking
- What is being tested?
- Packout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Apr 2019
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age range 18-55 y
- normal weight to overweight/obese (BMI: 18-32 kg/m2)
- healthy, non-diabetic
- not currently or previously on a weight loss or other special diet (in the past 6 months)
- non-smoking (for the past 6 months)
- not been clinically diagnosed with an eating disorder
- habitually eat afternoon/evening snacks at least 4 days/week
Who cannot join
- Clinically diagnosed with an eating disorder
- Metabolic, hormonal, and/or neural conditions/diseases that influence metabolism or appetite
- Currently or previously on a weight loss or other special diet (in the past 6 months)
- Gained/lost >10 lb. over the past 6 months
- Taking medication that would directly influence appetite (weight-loss drugs or antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 3 months)
- Not willing or able to complete all study testing procedures
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose a randomized snack study in normal to obese adults that will test whether snack size, choice, or variety has an influence on daily snack intake.
Aim 1: To validate the in-house packout methodology with 3-day dietary recalls. Aim 2: To examine whether snack variety or snack package size will influence free-living snacking behavior.
Aim 3: To identify whether a correlation exists between mindful eating and free-living snacking behavior.
Read the detailed description
Participants will complete 4 different snack patterns. Each pattern will include 3 nonconsecutive weekdays (i.e., Monday/Wednesday/Friday; Tuesday/Thursday/Monday, etc.). The snack patterns will be performed at home/work.
The first pattern will simply be a measurement of typical snack habits. For each of the 3 days, the participant will enter all foods and beverages consumed using the online program, Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA-24).
For the other 3 patterns, different snack packouts will be provided to the participant for 3 nonconsecutive weekdays/pattern. The only difference between the packouts is the type of foods provided. The packouts contain commercially available foods commonly eaten by people who snack. Following lunch, the participant will be permitted to eat as much or as little as he/she chooses from the packout until going to bed. Beverages will not be provided and the participant could drink whatever he/she typically consumes.
For all patterns, the participant will be provided with a standardized breakfast, lunch, and dinner to consume at home/work for each of the 3 days/pattern.
- Conditions
- Snacking
- Being tested
- Packout
- Keywords
- intuitive eating, package size, food variety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PackoutBehavioural
Each packout provided during 3 of the 4 snack patterns will contain a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch. There are 3 different packouts that will be provided for 3 nonconsecutive weekdays (for a total of 9 packouts). Each packout contains the same calories and types of foods. However, they differ in packaging size and variety.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | For 3 days during the control snack pattern, the participants will be asked to complete dietary recalls concerning their afternoon and evening snacking behavior. The participants will use the Automated Self-Administered 24-hour Recall (ASA24) system which was developed by the National Cancer Institute. |
| Standard Packout | Active comparator | This packout contains a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch. Receives: Behavioral: Packout |
| Large Package Packout | Active comparator | This packout contains a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch. It differs from the Standard Packout in that the package sizes of all the foods are larger (though food amount remains the same). Receives: Behavioral: Packout |
| Variety Packout | Active comparator | This packout contains a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch. It differs from the Standard Packout in that there is about twice as much snack variety (though food amount remains the same). Receives: Behavioral: Packout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum Snack Energy Intake
Free-living energy intake will be assessed on the three testing days of each testing arm. For the control testing days, the participant will be provided with a standardized breakfast, lunch, and dinner, and will be required to log any snacks consumed on the Automated Self-Administered Recall System (ASA24). For each pack-out testing day, the participant will be provided a standardized breakfast, lunch, and dinner, as well as an excess of snacks to consume, ad libitum, throughout the day. All food items will be initially weighed and recorded. The participants will be instructed to return all uneaten foods as well as all wrappers and containers from consumed food. Any partially eaten, returned items will be weighed accordingly. The snacking and daily energy intake (as well as protein, carbohydrate, sugar, fiber, and fat intake) will be assessed from these pack-outs.
Measured: 12 testing days across ~4-6 weeks
Ad libitum Food Category Intake
Free-living food category intake will be assessed on the three testing days of each packout. The participant will be provided a standardized breakfast, lunch, and dinner, as well as an excess of snacks to consume, ad libitum, throughout the day. All food items will be initially weighed and recorded. The participants will be instructed to return all uneaten foods as well as all wrappers and containers from consumed food. Any partially eaten, returned items will be weighed accordingly. The snack intake of different food categories (i.e. desserts and candy, salty, high fat, high sugar, fruits and vegetables) will be assessed from these pack-outs.
Measured: 9 testing days across ~3-5 weeks
Secondary outcomes (1)
Intuitive Eating Score (1-5)
Participant will complete Intuitive Eating Scale-2 survey in order to receive an Intuitive Eating Score. The survey includes a 1 to 5 likert scale with 1 being 'strongly disagree' and 5 being 'strongly agree'. Min score is 1; Max score is 5. The higher the number, the greater the intuitive eating.
Measured: Baseline (at beginning of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Oct 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SnackingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- tightly-controlled, randomized cross-over design
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Sabra Dipping Company, LLC
- Responsible party
- Principal investigator, Heather Leidy, Purdue University
- Investigators
- Heather J Leidy, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940105
- Sponsor's protocol ID
- 1807020783
- Status last verified
- Jan 2022
- First submitted
- 5 May 2019
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in snacking behavior. Data shared will be coded, with no protected health information or identifiable data. A material transfer agreement is requested with approval of the sharing of data.
Publications
Reister EJ, Leidy HJ. Snack Package Size and Variety Differentially Influence Energy Intake and Food Choices in Healthy Adults. Curr Dev Nutr. 2022 Jan 17;6(2):nzac004. doi: 10.1093/cdn/nzac004. eCollection 2022 Feb.
PubMed 35155984
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Snack Size and Variety on Appetite Control, Satiety, and Eating Behavior in Healthy Adults.
- ClinicalTrials.gov ID
- NCT03940105
- Acronym / sponsor ID
- 1807020783
- Conditions
- Snacking
- Keywords
- intuitive eating, package size, food variety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Sabra Dipping Company, LLC
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 7 May 2019 (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 investigators propose a randomized snack study in normal to obese adults that will test whether snack size, choice, or variety has an influence on daily snack intake.
Aim 1: To validate the in-house packout methodology with 3-day dietary recalls. Aim 2: To examine whether snack variety or snack package size will influence free-living snacking behavior.
Aim 3: To identify whether a correlation exists between mindful eating and free-living snacking behavior.
Detailed description
Participants will complete 4 different snack patterns. Each pattern will include 3 nonconsecutive weekdays (i.e., Monday/Wednesday/Friday; Tuesday/Thursday/Monday, etc.). The snack patterns will be performed at home/work.
The first pattern will simply be a measurement of typical snack habits. For each of the 3 days, the participant will enter all foods and beverages consumed using the online program, Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA-24).
For the other 3 patterns, different snack packouts will be provided to the participant for 3 nonconsecutive weekdays/pattern. The only difference between the packouts is the type of foods provided. The packouts contain commercially available foods commonly eaten by people who snack. Following lunch, the participant will be permitted to eat as much or as little as he/she chooses from the packout until going to bed. Beverages will not be provided and the participant could drink whatever he/she typically consumes.
For all patterns, the participant will be provided with a standardized breakfast, lunch, and dinner to consume at home/work for each of the 3 days/pattern.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- tightly-controlled, randomized cross-over design
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –For 3 days during the control snack pattern, the participants will be asked to complete dietary recalls concerning their afternoon and evening snacking behavior. The participants will use the Automated Self-Administered 24-hour Recall (ASA24) system which was developed by the National Cancer Institute. |
| Standard Packout | Active comparator | Behavioral: PackoutThis packout contains a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch. |
| Large Package Packout | Active comparator | Behavioral: PackoutThis packout contains a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch. It differs from the Standard Packout in that the package sizes of all the foods are larger (though food amount remains the same). |
| Variety Packout | Active comparator | Behavioral: PackoutThis packout contains a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch. It differs from the Standard Packout in that there is about twice as much snack variety (though food amount remains the same). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age range 18-55 y
- normal weight to overweight/obese (BMI: 18-32 kg/m2)
- healthy, non-diabetic
- not currently or previously on a weight loss or other special diet (in the past 6 months)
- non-smoking (for the past 6 months)
Key exclusion criteria (6 listed)
- Clinically diagnosed with an eating disorder
- Metabolic, hormonal, and/or neural conditions/diseases that influence metabolism or appetite
- Currently or previously on a weight loss or other special diet (in the past 6 months)
- Gained/lost >10 lb. over the past 6 months
- Taking medication that would directly influence appetite (weight-loss drugs or antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 3 months)
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 |
|---|---|---|
| PackoutEach packout provided during 3 of the 4 snack patterns will contain a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch. There are 3 different packouts that will be provided for 3 nonconsecutive weekdays (for a total of 9 packouts). Each packout contains the same calories and types of foods. However, they differ in packaging size and variety. | Behavioural | Large Package Packout, Standard Packout, Variety Packout |
Primary outcome
Ad libitum Snack Energy Intake
Time frame: 12 testing days across ~4-6 weeks
Free-living energy intake will be assessed on the three testing days of each testing arm. For the control testing days, the participant will be provided with a standardized breakfast, lunch, and dinner, and will be required to log any snacks consumed on the Automated Self-Administered Recall System (ASA24). For each pack-out testing day, the participant will be provided a standardized breakfast, lunch, and dinner, as well as an excess of snacks to consume, ad libitum, throughout the day. All food items will be initially weighed and recorded. The participants will be instructed to return all uneaten foods as well as all wrappers and containers from consumed food. Any partially eaten, returned items will be weighed accordingly. The snacking and daily energy intake (as well as protein, carbohydrate, sugar, fiber, and fat intake) will be assessed from these pack-outs.
Ad libitum Food Category Intake
Time frame: 9 testing days across ~3-5 weeks
Free-living food category intake will be assessed on the three testing days of each packout. The participant will be provided a standardized breakfast, lunch, and dinner, as well as an excess of snacks to consume, ad libitum, throughout the day. All food items will be initially weighed and recorded. The participants will be instructed to return all uneaten foods as well as all wrappers and containers from consumed food. Any partially eaten, returned items will be weighed accordingly. The snack intake of different food categories (i.e. desserts and candy, salty, high fat, high sugar, fruits and vegetables) will be assessed from these pack-outs.
1 secondary outcome
Intuitive Eating Score (1-5)
Time frame: Baseline (at beginning of study)
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 21 Jan 2022.
- Derived from this study: PubMed 35155984Reister EJ, Leidy HJ. Snack Package Size and Variety Differentially Influence Energy Intake and Food Choices in Healthy Adults. Curr Dev Nutr. 2022 Jan 17;6(2):nzac004. doi: 10.1093/cdn/nzac004. eCollection 2022 Feb.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in snacking behavior. Data shared will be coded, with no protected health information or identifiable data. A material transfer agreement is requested with approval of the sharing of data.
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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.
Heather J Leidy, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Packout in people with Snacking, run by Purdue University 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 7 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 21 Jan 2022. 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?
Ad libitum Snack Energy Intake (time frame: 12 testing days across ~4-6 weeks). The study lists 2 primary outcomes in all. 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 NCT03940105, which also lists 1 linked publication.
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 21 Jan 2022.