跳至主要内容
临床试验/NCT02674971
NCT02674971已完成不适用

Lowering Caloric Density of the Diet

The University of Tennessee, Knoxville2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Dietary: Macronutrients

研究概览

简要总结

For weight loss to occur, energy intake needs to be reduced to incur an energy deficit. One dietary strategy that may facilitate reducing energy intake and enhancing weight loss is consuming a diet low in dietary energy density (ED). The ED of a given food, defined as the ratio of energy of the food to the weight of the food (kcal/g), is largely determined by water content, but is also affected by fat and fiber. Although the 2010 Dietary Guidelines encourage an eating pattern low in energy density (ED) to manage weight, it is currently not known what the best strategy is for reducing ED in the diet. Eating a greater number of foods low in ED or reducing the number of foods high in ED may reduce overall dietary ED. As ED is believed to reduce intake by allowing a greater weight of food relative to total energy consumed assisting with enhancing feelings of fullness, it is anticipated that either increasing consumption of low-ED foods in the diet alone or combining an increase in consumption of low-ED foods with a decrease in consumption of high-ED foods may be the best strategies for reducing overall dietary ED for weight loss.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1) age between 18 and 65 years and 2) a body mass index (BMI)7 between 27 and 45 kg/m2.

排除标准

  • report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q)8 (medical conditions that could limit exercise for safety reasons will be required to obtain written physician consent before participating in the investigation)
  • report being unable to walk for 2 blocks (1/4 mile) without stopping
  • 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
  • report major psychiatric diseases or organic brain syndromes
  • have had bariatric surgery or are planning to have bariatric surgery within the next 4 months
  • intend to move outside of the metropolitan area within the time frame of the investigation
  • are pregnant, lactating, < 6 months post-partum, or plan to become pregnant during the investigation.

研究组 & 干预措施

INCREASE

Active Comparator

This condition will be instructed to make food consumption decisions based solely upon the ED of a food. The goal of the ED condition will be to consume at least 10 foods ≤ 1.0 kcal/g (i.e., fruits and vegetables, broth based soups, non-fat yogurts, some legumes, egg substitutes, some white fish, etc.) per day.

干预措施: Common components of intervention (Behavioral)

COMBINATION

Active Comparator

This condition will be identical to the INCREASE condition, except it will also have a goal regarding the number of high-ED foods to consume and substituting low-ED foods for high-ED foods. Thus, this condition will have ED goals to consume at least 10 foods ≤ 1.0 kcal/g (i.e., fruits and vegetables, broth based soups, non-fat yogurts, some legumes, egg substitutes, some white fish, etc.) and no more than 2 foods ≥ 3.0 kcal/g (i.e., crackers, chips, cookies, hard cheeses, hot dogs, salad dressings, etc.) per day. Foods with an ED >1.0 kcal/g but < 3.0 kcal/g will be unlimited; however, lower ED foods will be strongly encouraged. Furthermore, additions to beverages (i.e., sugar, cream) will count toward the > 3.0 kcal/g goal if the additions meet that ED criteria.

干预措施: Common components of intervention (Behavioral)

结局指标

主要结局

Dietary: Macronutrients

时间窗: change from baseline to 12 weeks

Changes in overall dietary intake and changes per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.

Physical activity

时间窗: change from baseline to 12 weeks

Changes in self-reported physical activity will be determined by the Paffenbarger Activity Questionnaire (PAQ).16 This questionnaire yields estimates of the total energy expended in PA per week based on flights of stairs climbed per day, city blocks walked per day, and hours of structured activity acquired within a typical week. The PAQ has been shown to be significantly correlated with an objective measure of PA.

Dietary: Grams of Intake

时间窗: change from baseline to 12 weeks

Changes in overall dietary intake and changes per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.

Dietary: Energy Density

时间窗: change from baseline to 12 weeks

Changes in overall dietary intake and changes per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.

Dietary: Fiber

时间窗: change from baseline to 12 weeks

Changes in overall dietary intake and changes per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.

BMI

时间窗: change from baseline to 12 weeks

Change in BMI (kg/m2) will be calculated from height and weight measures.

Height

时间窗: baseline

Height will be assessed by stadiometer, using standard procedures.

Dietary: Energy Intake

时间窗: change from baseline to 12 weeks

Changes in overall dietary intake and changes per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.

Ecological Momentary Assessment (EMA)

时间窗: change from baseline to 12 weeks

(EMA) refers to a collection of methods often used in behavioral medicine research by which a research participant repeatedly reports on symptoms, affect, behavior, and cognitions close in time to experience and in the participants' natural environment. EMA protocol will be conducted over 7 continuous days using both semi-random and event-contingent sampling. Semi-random responses will be collected at varied times within three windows (morning, afternoon, and evening), with three assessments occurring per day triggered by an alarm prompt that signals a 30-minute window for response. Event-based sampling will be used to assess eating bouts. Semi-random sampling will assess consumption cues (i.e. feelings of temptation, fullness, desire to eat, energy level and control over eating), along with feelings of hunger, satiation, and deprivation using a series of 11 questions.

Weight

时间窗: change from baseline to 12 weeks

Change in weight will be assessed by an electronic scale, using standard procedures.

次要结局

  • Diet satisfaction(12 weeks)

研究者

发起方
The University of Tennessee, Knoxville
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hollie Raynor

Professor

The University of Tennessee, Knoxville

研究点 (2)

Loading locations...

相似试验