The Healthy Eating Choices for Life Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Standard Behavioral Weight Loss Intervention
* Behavioral: Dietary Goal: Reduction in Energy Density of Dietary Intake
* Behavioral: Dietary Goal: Reduction of Energy Intake


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Weeks 0 and 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss |  | Weeks 0 and 13 | 
| 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). | Weeks 0 and 13 | 
| 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). | Weeks 0 and 13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight, Dietary intake, Energy Density, Behavioral, Satiety, Deprivation, Hunger, Fruit, Vegetable