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The Healthy Eating Choices for Life Program (HEC4L)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hollie Raynor, University of Tennessee
ClinicalTrials.gov Identifier:
NCT01096719
First received: March 24, 2010
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Energy density of the diet [ Time Frame: Weeks 0 and 13 ] [ Designated as safety issue: No ]
    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:
  • Weight Loss [ Time Frame: Weeks 0 and 13 ] [ Designated as safety issue: No ]
  • Feelings of dietary deprivation and satisfaction [ Time Frame: Weeks 0 and 13 ] [ Designated as safety issue: No ]
    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).

  • Hunger [ Time Frame: Weeks 0 and 13 ] [ Designated as safety issue: No ]
    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).


Enrollment: 45
Study Start Date: January 2010
Study Completion Date: August 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096719

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

Additional Information:
Healthy Eating and Activity Laboratory Homepage  This link exits the ClinicalTrials.gov site

No publications provided by University of Tennessee

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hollie Raynor, Associate professor, University of Tennessee
ClinicalTrials.gov Identifier: NCT01096719     History of Changes
Other Study ID Numbers: IRB 8107 B
Study First Received: March 24, 2010
Last Updated: November 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
Weight
Dietary intake
Energy Density
Behavioral
Satiety
 Deprivation
Hunger
Fruit
Vegetable

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013