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NCT Number: NCT01096719

The Healthy Eating Choices for Life Program

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.

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Key information

Conditions

Obesity Behavior Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Healthy Eating and Activity Laboratory

Knoxville, Tennessee, 37996-1920, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Behavioral Weight Loss Intervention

Behavioral

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

Dietary Goal: Reduction in Energy Density of Dietary Intake

Behavioral

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.

Dietary Goal: Reduction of Energy Intake

Behavioral

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Registry information

Official study 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.

Acronym: HEC4L

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Mar 31, 2010
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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