NCT03783507

Brief Summary

For weight loss to occur, energy intake needs to be reduced to incur an energy deficit. One dietary strategy that may facilitate weight loss is consuming a diet low in dietary energy density (ED). It is hypothesized that a diet low in ED, which can be achieved by a high intake of low-ED foods, low intake of high-ED foods, or a combination of the two, will allow a greater amount of volume of food to be consumed relative to energy consumed, which can assist with reducing energy intake. To understand how best to lower the ED of the diet, it is important to understand the relationship between low-ED and high-ED foods. Behavioral economics is a framework that provides a foundation to understand that eating behaviors can be substitutes for each other. Substitute eating behaviors are two behaviors that change in the opposite direction of each other (i.e. one behavior increases as the other behavior decreases). If low-ED and high-ED foods are substitutes for each other, in situations in which low-ED food intake increases, high-ED food should automatically decrease, and vice versa. If they are not substitutes, when low-ED food intake increases, high-ED food intake should remain unchanged, and when high-ED food intake decreases, low-ED food intake should remain unchanged. When low-Ed and high-ED foods are not substitutes for each other, purposeful change in intake for both low- and high-ED foods need to occur to best lower dietary ED. Thus, the purpose of this study is to investigate if low-ED foods and high-ED foods substitute for each other. Healthy weight adults will be served a meal over 4 sessions, with each meal containing 5 different food items. The foods in the meal will vary in ED: low-ED = 0 to 1.0 kcal/kg; medium-ED = 1.1 to 2.9 kcal/kg; high-ED = \> 3.0 kcal/g. For the 4 sessions, the meals will include: 1) 3 low-ED foods, 0 medium-ED foods, 2 high-ED foods; 2) 3 low-ED foods, 1 medium-ED food, 1 high-ED food; 3) 1 low-ED food, 2-medium ED foods, 2 high-ED foods; and 4) 1 low-ED food, 3 medium-ED foods, and 1 high-ED food.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

December 13, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 3, 2025

Status Verified

April 1, 2025

Enrollment Period

7 years

First QC Date

December 2, 2018

Last Update Submit

April 1, 2025

Conditions

Keywords

Energy Density

Outcome Measures

Primary Outcomes (4)

  • Meal Session 1 Consumption

    Energy intake will be calculated based upon grams consumed, manufacturer labels, and Nutrition Data System for Research (NDSR).

    After 30 minute meal

  • Meal Session 2 Consumption

    Energy intake will be calculated based upon grams consumed, manufacturer labels, and Nutrition Data System for Research (NDSR).

    After 30 minute meal

  • Meal Session 3 Consumption

    Energy intake will be calculated based upon grams consumed, manufacturer labels, and Nutrition Data System for Research (NDSR).

    After 30 minute meal

  • Meal Session 4 Consumption

    Energy intake will be calculated based upon grams consumed, manufacturer labels, and Nutrition Data System for Research (NDSR).

    After 30 minute meal

Study Arms (4)

Order 1

EXPERIMENTAL

Meal 1, Meal 2, Meal 3, Meal 4

Behavioral: Order 1

Order 2

EXPERIMENTAL

Meal 2, Meal 3, Meal 4, Meal 1

Behavioral: Order 2

Order 3

EXPERIMENTAL

Meal 3, Meal 4, Meal 1, Meal 2

Behavioral: Order 3

Order 4

EXPERIMENTAL

Meal 4, Meal 1, Meal 2, Meal 3

Behavioral: Order 4

Interventions

Order 1BEHAVIORAL

Meal Order 1: Meal Session 1 participant receives meal 1 (3 low-ED, 0 medium-ED, 2 high-ED) Meal Session 2 participant receives meal 2 (3 low-ED, 1 medium-ED,1 high-ED) Meal Session 3 participant receives meal 3 (1 low-ED, 2-medium ED, 2 high-ED) Meal Session 4 participant receives meal 4 (1 low-ED, 3 medium-ED, 1 high-ED)

Order 1
Order 2BEHAVIORAL

Meal Order 2: Meal Session 1 participant receives meal 2 (3 low-ED, 1 medium-ED,1 high-ED) Meal Session 2 participant receives meal 3 (1 low-ED, 2-medium ED, 2 high-ED) Meal Session 3 participant receives meal 4 (1 low-ED, 3 medium-ED, 1 high-ED) Meal Session 4 participant receives meal 1 (3 low-ED, 0 medium-ED, 2 high-ED)

Order 2
Order 3BEHAVIORAL

Meal Order 3: Meal Session 1 participant receives meal 3 (1 low-ED, 2-medium ED, 2 high-ED) Meal Session 2 participant receives meal 4 (1 low-ED, 3 medium-ED, 1 high-ED) Meal Session 3 participant receives meal 1 (3 low-ED, 0 medium-ED, 2 high-ED) Meal Session 4 participant receives meal 2 (3 low-ED, 1 medium-ED,1 high-ED)

Order 3
Order 4BEHAVIORAL

Meal Order 4: Meal Session 1 participant receives meal 4 (1 low-ED, 3 medium-ED, 1 high-ED) Meal Session 2 participant receives meal 1 (3 low-ED, 0 medium-ED, 2 high-ED) Meal Session 3 participant receives meal 2 (3 low-ED, 1 medium-ED,1 high-ED) Meal Session 4 participant receives meal 3 (1 low-ED, 2-medium ED, 2 high-ED)

Order 4

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 35 years;
  • body mass index (BMI) 18.5 to 24.9 kg/m2;
  • unrestrained eater (≤12 on Three Factor Eating Questionnaire (TFEQ);
  • chicken or tomato soup, chocolate sugar-free pudding, grapes, blueberry yogurt, macaroni and cheese, vanilla ice cream, pretzels, and honey graham snacks (rate all items ≥ 50mm on a visual analogue scale (VAS);
  • report regularly eating before 10 am; and
  • can complete all sessions within 8 weeks of the screening session, will be eligible for the study.

You may not qualify if:

  • report binge eating;
  • report a medical condition that influences eating;
  • report allergies to foods used in the investigation;
  • currently smoke;
  • report dietary restrictions;
  • report taking a medication that affects appetite;
  • report being pregnant or breast-feeding;
  • report being an athlete in training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee, Knoxville

Knoxville, Tennessee, 37996-1920, United States

Location

Related Publications (5)

  • Rolls BJ, Drewnowski A, Ledikwe JH. Changing the energy density of the diet as a strategy for weight management. J Am Diet Assoc. 2005 May;105(5 Suppl 1):S98-103. doi: 10.1016/j.jada.2005.02.033.

    PMID: 15867904BACKGROUND
  • Rolls BJ. The relationship between dietary energy density and energy intake. Physiol Behav. 2009 Jul 14;97(5):609-15. doi: 10.1016/j.physbeh.2009.03.011. Epub 2009 Mar 20.

    PMID: 19303887BACKGROUND
  • Epstein, L.H.; Saelens, B.E. Behavioral Economics of Obesity: Food Intake and Energy Expenditure. In Reframing Health Behavior Change with Behavioral Economics; Bickel, W.K., Vuchinich, R.E., Eds.; Lawrence Associate, Inc.: Mahwah, NJ, USA, 2000; pp. 293-311.

    BACKGROUND
  • Just, D.R.; Mancino, L.; Wansink, B. Could Behavioral Economics Help Improve Diet Quality for Nutrition Assistance Program Participants? Economic Research Report No. ERR-43; U.S. Department of Agriculture: Washington, DC, USA, 2007.

    BACKGROUND
  • Madden, G.J. A Behavioral Economics Primer. In Reframing Health Behavior Change with Behavioral Economics; Bickel, W.K., Vuchinich, R.E., Eds.; Lawrence Associate, Inc.: Mahwah, NJ, USA, 2000; pp. 3-26.

    BACKGROUND

MeSH Terms

Conditions

Feeding BehaviorObesity

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hollie Raynor, PhD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
FACTORIAL
Model Details: In order to examine if low-ED foods and high-ED foods substitute for each other, a 4 X 4 mixed-factor design with a between-subjects factor of order and a within-subjects factor of meal will be used. For the within-subjects factor of meal, four meal conditions will be implemented. Participants will be randomized to one of 4 orders to reduce the possibility of an order effect. During all sessions, participants will be provided with 12 ounces of water.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean of Research

Study Record Dates

First Submitted

December 2, 2018

First Posted

December 21, 2018

Study Start

December 13, 2018

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 3, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations