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The Healthy Eating Choices for Life Program (HEC4L)

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ClinicalTrials.gov Identifier: NCT01096719
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Hollie Raynor, The University of Tennessee, Knoxville

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Standard Behavioral Weight Loss Intervention Behavioral: Dietary Goal: Reduction in Energy Density of Dietary Intake Behavioral: Dietary Goal: Reduction of Energy Intake Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Diets Targeting Energy Density and Energy Restriction on Weight Loss and Feelings of Deprivation, Satisfaction, and Hunger During Behavioral Weight Loss Treatment.
Study Start Date : January 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Energy Density Behavioral: Standard Behavioral Weight Loss Intervention
12 week standard behavioral weight loss intervention including a physical activity goal and behavioral weight control strategies
Behavioral: Dietary 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.
Active Comparator: Lifestyle Treatment Behavioral: Standard Behavioral Weight Loss Intervention
12 week standard behavioral weight loss intervention including a physical activity goal and behavioral weight control strategies
Behavioral: Dietary Goal: Reduction of Energy Intake
Limit energy intake to 1200 to 1500 kcals/day and < 30% kcals from fat.
Experimental: Energy Density + Lifestyle Treatment Behavioral: Standard Behavioral Weight Loss Intervention
12 week standard behavioral weight loss intervention including a physical activity goal and behavioral weight control strategies
Behavioral: Dietary 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.
Behavioral: Dietary Goal: Reduction of Energy Intake
Limit energy intake to 1200 to 1500 kcals/day and < 30% kcals from fat.



Primary Outcome Measures :
  1. Energy density of the diet [ Time Frame: Weeks 0 and 13 ]
    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).


Secondary Outcome Measures :
  1. Weight Loss [ Time Frame: Weeks 0 and 13 ]
  2. Feelings of dietary deprivation and satisfaction [ Time Frame: Weeks 0 and 13 ]
    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).

  3. Hunger [ Time Frame: Weeks 0 and 13 ]
    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).



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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096719


Locations
United States, Tennessee
Healthy Eating and Activity Laboratory
Knoxville, Tennessee, United States, 37996-1920
Sponsors and Collaborators
The University of Tennessee, Knoxville
Investigators
Principal Investigator: Hollie A Raynor, PhD, RD, LDN University of Tennessee

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hollie Raynor, Professor, The University of Tennessee, Knoxville
ClinicalTrials.gov Identifier: NCT01096719     History of Changes
Other Study ID Numbers: IRB 8107 B
First Posted: March 31, 2010    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by Hollie Raynor, The University of Tennessee, Knoxville:
Weight
Dietary intake
Energy Density
Behavioral
Satiety
Deprivation
Hunger
Fruit
Vegetable