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CompletedNCT01096719HEC4LUpdated Apr 5, 2018

The Healthy Eating Choices for Life Program

An interventional study of Standard Behavioral Weight Loss Intervention and Dietary Goal: Reduction in Energy Density of Dietary Intake in Obesity, sponsored by The University of Tennessee, Knoxville. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-04-05.

Sponsored by The University of Tennessee, Knoxville · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study summary

The purpose of this investigation is to conduct a 12-week pilot study to examine the effect of three different dietary prescriptions that differ on targeting reducing energy density (kcal/gram) and energy (kcal) on overall dietary intake, hunger, feelings of deprivation, satisfaction with the diet, mood, and weight loss in 45 overweight/obese adults receiving a 12-week behavioral weight loss intervention.

Read the detailed description

Given the current prevalence of overweight and obesity among adults in the United States and the projected increase of these conditions in the future, development of effective weight loss and weight loss maintenance strategies is imperative. For weight loss to occur, energy intake needs to be reduced to incur an energy deficit, and for successful weight loss maintenance, energy intake needs to remain lower than energy intake at pre-weight loss levels due to an overall reduction in body size which reduces basal metabolic rate. One dietary strategy that may facilitate weight loss maintenance is consuming a diet low in dietary energy density (ED). This pilot study will test the effects of a dietary prescription focused on ED.

All participants in the investigation will receive a standard 12-week behavioral obesity intervention. The intervention will include an activity goal that participants will gradually work to achieve over the course of the 12-week intervention along with standard behavioral weight loss strategies. One condition will receive a dietary prescription for weight loss that focuses solely on lowering the ED of the diet, another condition will receive the traditional dietary prescription used in behavioral weight loss interventions that reduces energy intake, and the third condition will receive both prescriptions. Pre and post intervention measurements will be taken to determine if there are differences between groups.

02

Conditions studied

  • Obesity

Keywords

  • Weight
  • Dietary intake
  • Energy Density
  • Behavioral
  • Satiety
  • Deprivation
  • Hunger
  • Fruit
  • Vegetable
03

In context

Lead sponsor

The University of Tennessee, Knoxville is the lead sponsor of 95 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age between 21 and 65 years
  • Body mass index (BMI) between 25 and 45 kg/m2

Exclusion criteria

Exclusion Criteria:

  • Report a health condition on the Physical Activity Readiness Questionnaire (PAR-Q)
  • Report being unable to walk for 2 blocks (1/4 mile) without stopping
  • Report major psychiatric diseases/organic brain syndromes via a phone screen
  • 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
  • Intend to move to another city within the time frame of the investigation
  • Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation
  • Have had gastric surgery for weight loss
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Energy Density

    Behavioral: Standard Behavioral Weight Loss Intervention · Behavioral: Dietary Goal: Reduction in Energy Density of Dietary Intake

  • Active comparator
    Lifestyle Treatment

    Behavioral: Standard Behavioral Weight Loss Intervention · Behavioral: Dietary Goal: Reduction of Energy Intake

  • Experimental
    Energy Density + Lifestyle Treatment

    Behavioral: Standard Behavioral Weight Loss Intervention · Behavioral: Dietary Goal: Reduction in Energy Density of Dietary Intake · Behavioral: Dietary Goal: Reduction of Energy Intake

Interventions

  • BehavioralStandard Behavioral Weight Loss Intervention

    12 week standard behavioral weight loss intervention including a physical activity goal and behavioral weight control strategies

  • BehavioralDietary Goal: Reduction in Energy Density of Dietary Intake

    Consume low ED foods (ED \< 1.0) for at least 10 items consumed per day and limit high ED foods (ED \> 3.0) to two items consumed per day.

  • BehavioralDietary Goal: Reduction of Energy Intake

    Limit energy intake to 1200 to 1500 kcals/day and \< 30% kcals from fat.

06

What researchers measure

Primary outcomes

  1. Energy density of the diet

    Energy density is defined as the kilocalories per gram of a food. Energy density will be measured by collecting and analyzing 3-day food records using Nutrition Data Systems for Research at baseline (week 0) and post intervention (week 13).

    Time frame: Weeks 0 and 13

Secondary outcomes

  1. Weight Loss

    Time frame: Weeks 0 and 13

  2. Feelings of dietary deprivation and satisfaction

    Dietary deprivation and satisfaction will be measures using 100mm visual analog scales with the statements "I feel like I ate enough today" and "I feel like I ate what I wanted today". Both scales are anchored with "strongly disagree" on one end and "strongly agree" on the other end. These will be collected for 7 days at baseline (week 0) and post intervention (week 13).

    Time frame: Weeks 0 and 13

  3. Hunger

    Hunger will be measured using a 100mm visual analog scale. The scale asks "How hungry did you feel today?" and is anchored with "not at all hungry" on one end and "extremely hungry" on the other. Hunger scales will be collected for 7 days at baseline (week 0) and post intervention (week 13).

    Time frame: Weeks 0 and 13

07

Study locations

1 site
  • Healthy Eating and Activity Laboratory
    Knoxville, Tennessee 37996-1920, United States
08

References and documents

Publications

  • Raynor HA, Steeves EA, Hecht J, Fava JL, Wing RR. Limiting variety in non-nutrient-dense, energy-dense foods during a lifestyle intervention: a randomized controlled trial. Am J Clin Nutr. 2012 Jun;95(6):1305-14. doi: 10.3945/ajcn.111.031153. Epub 2012 May 2. PubMed 22552025 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01096719
Lead sponsor
The University of Tennessee, Knoxville
Responsible party
Hollie Raynor (Professor, The University of Tennessee, Knoxville) — Principal investigator
First posted
Mar 31, 2010
Start date
Jan 2010
Primary completion
Jul 2010
Completion
Aug 2011
Last update
Apr 5, 2018

Study contacts

Hollie A Raynor, PhD, RD, LDN
principal investigator · University of Tennessee

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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