Clinical trial NCT02674971: Lowering Caloric Density of the Diet
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Feeding Behavior
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dietary: Energy Intake
timeFrame: change from baseline to 12 weeks
measure: Physical activity
timeFrame: change from baseline to 12 weeks
measure: Ecological Momentary Assessment (EMA)
timeFrame: change from baseline to 12 weeks
measure: Weight
timeFrame: change from baseline to 12 weeks
measure: Dietary: Grams of Intake
timeFrame: change from baseline to 12 weeks
measure: Dietary: Energy Density
timeFrame: change from baseline to 12 weeks
measure: Dietary: Macronutrients
timeFrame: change from baseline to 12 weeks
measure: Dietary: Fiber
timeFrame: change from baseline to 12 weeks
measure: Height
timeFrame: baseline
measure: BMI
timeFrame: change from baseline to 12 weeks
Secondary outcomes:
measure: Diet satisfaction
timeFrame: 12 weeks
Other outcomes:
measure: Demographic characteristics
timeFrame: baseline
measure: Compliance
timeFrame: 12 weeks
measure: Weight History
timeFrame: baseline
Locations:
city: Knoxville
country: United States
facility: Healthy Eating and Activity Laboratory, University of Tennessee
state: Tennessee
Study officials:
References: