Lowering Caloric Density of the Diet (Lower CD)

June 5, 2026 updated by: Hollie Raynor, The University of Tennessee, Knoxville
For weight loss to occur, energy intake needs to be reduced to incur an energy deficit. One dietary strategy that may facilitate reducing energy intake and enhancing weight loss is consuming a diet low in dietary energy density (ED). The ED of a given food, defined as the ratio of energy of the food to the weight of the food (kcal/g), is largely determined by water content, but is also affected by fat and fiber. Although the 2010 Dietary Guidelines encourage an eating pattern low in energy density (ED) to manage weight, it is currently not known what the best strategy is for reducing ED in the diet. Eating a greater number of foods low in ED or reducing the number of foods high in ED may reduce overall dietary ED. As ED is believed to reduce intake by allowing a greater weight of food relative to total energy consumed assisting with enhancing feelings of fullness, it is anticipated that either increasing consumption of low-ED foods in the diet alone or combining an increase in consumption of low-ED foods with a decrease in consumption of high-ED foods may be the best strategies for reducing overall dietary ED for weight loss.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • Healthy Eating and Activity Laboratory, University of Tennessee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1) age between 18 and 65 years and 2) a body mass index (BMI)7 between 27 and 45 kg/m2.

Exclusion Criteria:

  1. report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q)8 (medical conditions that could limit exercise for safety reasons will be required to obtain written physician consent before participating in the investigation)
  2. report being unable to walk for 2 blocks (1/4 mile) without stopping
  3. are currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 6 months
  4. report major psychiatric diseases or organic brain syndromes
  5. have had bariatric surgery or are planning to have bariatric surgery within the next 4 months
  6. intend to move outside of the metropolitan area within the time frame of the investigation
  7. are pregnant, lactating, < 6 months post-partum, or plan to become pregnant during the investigation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: INCREASE
This condition will be instructed to make food consumption decisions based solely upon the ED of a food. The goal of the ED condition will be to consume at least 10 foods ≤ 1.0 kcal/g (i.e., fruits and vegetables, broth based soups, non-fat yogurts, some legumes, egg substitutes, some white fish, etc.) per day.
Behavioral: Common components of intervention
12-week standard lifestyle intervention for obesity, which consists of weekly meetings. Each meeting will last 60 minutes, with participants attending group meetings specific for their condition. In all meetings, participants will be weighed, homework assignments will be verbally reviewed, and a behavioral lesson will be presented. Basic behavioral lessons, will be similar to those that have been successfully used in the Diabetes Prevention Program (DPP) and Look AHEAD. Topics to be covered in the meetings will focus on the dietary prescriptions and dietary information for each condition, the physical activity goal, energy balance, and behavioral strategies. Each session will conclude with reminding participants of their dietary and physical activity goals, and having participants self-monitor these behaviors every day and implement the behavioral strategies discussed in the session.
Active Comparator: COMBINATION
This condition will be identical to the INCREASE condition, except it will also have a goal regarding the number of high-ED foods to consume and substituting low-ED foods for high-ED foods. Thus, this condition will have ED goals to consume at least 10 foods ≤ 1.0 kcal/g (i.e., fruits and vegetables, broth based soups, non-fat yogurts, some legumes, egg substitutes, some white fish, etc.) and no more than 2 foods ≥ 3.0 kcal/g (i.e., crackers, chips, cookies, hard cheeses, hot dogs, salad dressings, etc.) per day. Foods with an ED >1.0 kcal/g but < 3.0 kcal/g will be unlimited; however, lower ED foods will be strongly encouraged. Furthermore, additions to beverages (i.e., sugar, cream) will count toward the > 3.0 kcal/g goal if the additions meet that ED criteria.
Behavioral: Common components of intervention
12-week standard lifestyle intervention for obesity, which consists of weekly meetings. Each meeting will last 60 minutes, with participants attending group meetings specific for their condition. In all meetings, participants will be weighed, homework assignments will be verbally reviewed, and a behavioral lesson will be presented. Basic behavioral lessons, will be similar to those that have been successfully used in the Diabetes Prevention Program (DPP) and Look AHEAD. Topics to be covered in the meetings will focus on the dietary prescriptions and dietary information for each condition, the physical activity goal, energy balance, and behavioral strategies. Each session will conclude with reminding participants of their dietary and physical activity goals, and having participants self-monitor these behaviors every day and implement the behavioral strategies discussed in the session.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dietary: Energy Intake
Time Frame: change from baseline to 12 weeks
Changes in overall dietary intake and changes per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.
change from baseline to 12 weeks
Physical activity
Time Frame: change from baseline to 12 weeks
Changes in self-reported physical activity will be determined by the Paffenbarger Activity Questionnaire (PAQ).16 This questionnaire yields estimates of the total energy expended in PA per week based on flights of stairs climbed per day, city blocks walked per day, and hours of structured activity acquired within a typical week. The PAQ has been shown to be significantly correlated with an objective measure of PA.
change from baseline to 12 weeks
Ecological Momentary Assessment (EMA)
Time Frame: change from baseline to 12 weeks
(EMA) refers to a collection of methods often used in behavioral medicine research by which a research participant repeatedly reports on symptoms, affect, behavior, and cognitions close in time to experience and in the participants' natural environment. EMA protocol will be conducted over 7 continuous days using both semi-random and event-contingent sampling. Semi-random responses will be collected at varied times within three windows (morning, afternoon, and evening), with three assessments occurring per day triggered by an alarm prompt that signals a 30-minute window for response. Event-based sampling will be used to assess eating bouts. Semi-random sampling will assess consumption cues (i.e. feelings of temptation, fullness, desire to eat, energy level and control over eating), along with feelings of hunger, satiation, and deprivation using a series of 11 questions.
change from baseline to 12 weeks
Weight
Time Frame: change from baseline to 12 weeks
Change in weight will be assessed by an electronic scale, using standard procedures.
change from baseline to 12 weeks
Dietary: Grams of Intake
Time Frame: change from baseline to 12 weeks
Changes in overall dietary intake and changes per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.
change from baseline to 12 weeks
Dietary: Energy Density
Time Frame: change from baseline to 12 weeks
Changes in overall dietary intake and changes per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.
change from baseline to 12 weeks
Dietary: Macronutrients
Time Frame: change from baseline to 12 weeks
Changes in overall dietary intake and changes per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.
change from baseline to 12 weeks
Dietary: Fiber
Time Frame: change from baseline to 12 weeks
Changes in overall dietary intake and changes per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.
change from baseline to 12 weeks
Height
Time Frame: baseline
Height will be assessed by stadiometer, using standard procedures.
baseline
BMI
Time Frame: change from baseline to 12 weeks
Change in BMI (kg/m2) will be calculated from height and weight measures.
change from baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diet satisfaction
Time Frame: 12 weeks
The Food Acceptability Questionnaires will assess acceptability and satisfaction of diet at 12 weeks. Participants will be asked about ease of following the diet, ease of determining foods to consume to meet dietary goals, and ease of reading food labels to select foods to consume to meet dietary goals (which is all one questionnaire).
12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographic characteristics
Time Frame: baseline
baseline
Compliance
Time Frame: 12 weeks
Participation will be recorded.
12 weeks
Weight History
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Tennessee, Knoxville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UTKIRB-15-02609

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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