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临床试验/NCT04025099
NCT04025099已完成不适用

Internal Cues Versus External Cues for Eating and Activity

University of Delaware2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Intuitive Eating

研究概览

简要总结

The majority of female undergraduate students experience disordered eating and/or weight gain, increasing the risk for two serious public health problems, eating disorders and obesity. Traditional nutrition education about weight control delivered during college has not been effective and may even exacerbate these problems. Thus, the investigators propose that instead of focusing on external information as taught by nutrition education (e.g. 'calories in, calories out', quantification and cognitive processing of nutrition information), at-risk females be trained to become more attuned to their internal hunger and fullness signaling to set them on a trajectory for decreased chronic disease risk as they age.

详细描述

The proposed study, Internal versus External Cues for Eating and Activity, will collect data on within-person changes in psychological (e.g. attunement with bodily signals, eating and activity behaviors) and physiological (e.g., body mass index, heart rate, saliva) markers of risk for both eating disorders and obesity in female University of Delaware students. Outcomes will be assessed at baseline, mid-treatment, end-of-treatment, and one-year follow-up. This three-armed randomized, controlled trial will assess the effects of a novel internal cues intervention (treatment group; intuitive eating and body positive yoga) compared to an active control group consisting of traditional healthy weight sessions, following standardized government recommendations for eating and activity, and a no-treatment control group completing assessments only. The Internal Cues group will attend one intuitive eating session and take three body-positive yoga sessions weekly for ten weeks. The External Cues group will attend one healthy weight class and three cardiovascular-based exercise sessions each week for ten weeks. The Assessment Only no-treatment control group will only attend assessments. The curriculum for the intuitive eating classes (previously piloted and revised accordingly) and healthy weight classes (modeled off of classes offered at universities and government-available recommendations and educational documents) will be taught by two Registered Dietitians who are Certified Intuitive Eating Counselors. The yoga classes will be taught by a Registered Yoga Instructor trained in Body Positive Yoga and in a curriculum specifically designed for UD students (funded by Dean Matt). During the Internal Cues group's intuitive eating classes, participants will, as a group, eat dinner that is prepared by ServSafe certified undergraduate dietetics students in the test kitchen in the STAR Tower. This dinner will allow the participants to experientially learn the intuitive eating principles taught in class. The External Cues group will receive an identical dinner during the class period but they will learn how to properly portion their meals to meet their caloric needs, in line with traditional education about weight control. Finally, students randomized to the External Cues group will receive a UD fitness pass and will be able to choose from select cardio-based fitness classes in order to meet public health recommendations for physical activity.

Additionally, the interventionists for both the Internal Cues and External Cues sessions will be video recorded to allow content to be tested in a lab study following the intervention. The research team worked with IT at STAR campus to position equipment so that the video only captures the interventionists (session leaders). Participants will not be recorded. If any participant audio is captured, content containing participants' voices will be deleted from the file. The purpose of recording is to modify the curriculum for future interventions and programs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 26 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Between the ages of 18 and 26
  • Freshman, Sophomore, or Junior University of Delaware student
  • Willing and able to commit to the 10-week study at the specified times and a follow up visit 1-year after the completion of the study
  • Have concerns about body shape, weight, and/or eating
  • Are not currently being treated for an eating disorder

排除标准

  • They do not meet the inclusion criteria.
  • They have a severe medical food allergy.
  • They are pregnant - this program is not geared towards someone who is pregnant.

结局指标

主要结局

Intuitive Eating

时间窗: Follow-up - 1 year post study completion

Using the Intuitive Eating Scale-2 Measures tendency to follow physical hunger and fullness cues \*Total\*score range = 5-115 Higher scores indicate greater levels of intuitive eating or its dimensions

Interoceptive Awareness

时间窗: Follow-up - 1 year post study completion

Using the Multi-Dimensional Assessment of Interoceptive Awareness - 2 Measures the multiple levels of individual interoception \*Total\*score range = 0-185 Higher total scores and sub scale scores indicate higher levels of positive awareness

Dietary Restraint

时间窗: Follow-up - 1 year post study completion

Using the Three-Factor Eating Questionnaire-18 Measures dietary restraint Means are computed for three subscales and are transformed to a 0-100 scale score Higher scores indicate greater cognitive restraint, uncontrolled, emotional eating

Embodiment

时间窗: Follow-up - 1 year post study completion

Using the Experience of Embodiment Scale - Body Connection and Comfort Subscale Measures one of the five dimensions of embodiment: body connection and comfort Subscale score range = 12-36 Higher sub scale scores indicate higher levels of embodiment in terms of connection and comfort to one's body

Body Appreciation

时间窗: Follow-up - 1 year post study completion

Using the Body Appreciation Scale - 2 Measures one's acceptance of, favorable opinions toward, and respect for their body Score answers are totaled and divided by 10 for an average score. \*total\* average scores can range from = 1-5 Higher scores indicate higher levels of body appreciation

次要结局

  • Fruit Consumption(Follow-up - 1 year post study completion)
  • Vegetable Consumption(Follow-up - 1 year post study completion)
  • Participation in Yoga(Follow-up - 1 year post study completion)
  • Participation in Physical Activity(Follow-up - 1 year post study completion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carly R Pacanowski

Principal Investigator

University of Delaware

研究点 (2)

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