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

March 24, 2010
November 14, 2012
January 2010
July 2010   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01096719 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
The Healthy Eating Choices for Life Program
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • 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.
  • Experimental: Energy Density
    Interventions:
    • Behavioral: Standard Behavioral Weight Loss Intervention
    • Behavioral: Dietary Goal: Reduction in Energy Density of Dietary Intake
  • Active Comparator: Lifestyle Treatment
    Interventions:
    • Behavioral: Standard Behavioral Weight Loss Intervention
    • Behavioral: Dietary Goal: Reduction of Energy Intake
  • Experimental: Energy Density + Lifestyle Treatment
    Interventions:
    • Behavioral: Standard Behavioral Weight Loss Intervention
    • Behavioral: Dietary Goal: Reduction in Energy Density of Dietary Intake
    • Behavioral: Dietary Goal: Reduction of Energy Intake
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
August 2011
July 2010   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01096719
IRB 8107 B
No
Hollie Raynor, University of Tennessee
University of Tennessee
Not Provided
Principal Investigator: Hollie A Raynor, PhD, RD, LDN University of Tennessee
University of Tennessee
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP