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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03940105
Other study ID # 1807020783
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date April 1, 2019

Study information

Verified date January 2022
Source Purdue University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 1. age range 18-55 y 2. normal weight to overweight/obese (BMI: 18-32 kg/m2) 3. healthy, non-diabetic 4. not currently or previously on a weight loss or other special diet (in the past 6 months) 5. non-smoking (for the past 6 months) 6. not been clinically diagnosed with an eating disorder 7. habitually eat afternoon/evening snacks at least 4 days/week Exclusion Criteria: 1. Clinically diagnosed with an eating disorder 2. Metabolic, hormonal, and/or neural conditions/diseases that influence metabolism or appetite 3. Currently or previously on a weight loss or other special diet (in the past 6 months) 4. Gained/lost >10 lb. over the past 6 months 5. 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) 6. Not willing or able to complete all study testing procedures

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Packout
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.

Locations

Country Name City State
United States Purdue University West Lafayette Indiana

Sponsors (2)

Lead Sponsor Collaborator
Purdue University Sabra Dipping Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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)
See also
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Completed NCT03678779 - Snack It Up for Parents: Interventions to Improve Children's Snacks N/A