The Effects of Snack Size and Variety on Appetite Control, Satiety, and Eating Behavior in Healthy Adults.

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Snack Size and Variety on Appetite Control, Satiety, and Eating Behavior in Healthy Adults.

Conditions
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Snacking

Intervention / Treatment
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* Behavioral: Packout


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: tightly-controlled, randomized cross-over design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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. | |
| Active Comparator: Standard Packout<br>This packout contains a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch. | Behavioral: Packout<br>* 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.<br>|
| Active Comparator: Large Package Packout<br>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). | Behavioral: Packout<br>* 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.<br>|
| Active Comparator: Variety Packout<br>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). | Behavioral: Packout<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 9 testing days across  3-5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (at beginning of study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intuitive eating, package size, food variety