KU Alternate Meal Energy Level Study

赞助:

合作者:

信息的提供 (责任方):

Debra K. Sullivan, PhD, RD，University of Kansas Medical Center

追踪信息

首次提交日期 ^ICMJE

September 26, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

January 16, 2018

预计主要完成日期

October 2018 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Weight (lbs, % change from baseline)[ Time Frame: Change from baseline to 24 weeks ]

Change in absolute (lbs) and relative (%) weight from baseline to the end of the intervention (24 weeks)

Body composition[ Time Frame: Change from baseline to 24 weeks ]

Change in absolute (g) and relative (%) fat mass and fat-free mass from baseline to 24 weeks

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Program adherence[ Time Frame: weekly through study completion (24 weeks) ]
Compliance to intervention protocol; adherence = (# attained / # expected)*100
Nutrition-related quality of life[ Time Frame: baseline, week 12, week 24 ]
Assessed via questionnaire; higher scores indicate greater nutrition-related quality of life.
Dietary restraint[ Time Frame: baseline, week 12, week 24 ]
Assessed via three-factor eating questionnaire with three component scores for cognitive restraint, disinhibition, hunger)

描述性信息

简略标题 ^ICMJE

KU Alternate Meal Energy Level Study

正式标题 ^ICMJE

KU Alternate Meal Energy Level Study

简要概况

Compare intermittent versus continuous calorie restriction to learn more about these eating plans and determine whether they are useful and effective to lose weight and keep it off.

详细说明

The purpose of this study is to provide evidence for the feasibility of an alternative weight control strategy by comparing two diets to see how intermittent calorie restriction compares to continuous or daily calorie restriction for weight loss in 35 adults with overweight or obesity. These diets will be incorporated into a comprehensive and intensive weight management program involving weekly health education meetings, regular diet and physical activity tracking, and feedback from a registered dietitian. Each intervention includes 3 months of weight loss and 3 months of weight maintenance. Group 1: Follow a low-calorie diet every day (1,200 - 1,500 calories daily) Group 2: Follow an intermittent very-low calorie diet (500-800 calories). Participants in this group will alternate between days of 500-800 calories and days of structured eating using healthy eating principles.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Dietary Supplement: Portion-Controlled Meals
Increase dietary structure using portion-controlled meals (PCM)
Behavioral: Low-Calorie Diet
Restrict calorie intake daily
Behavioral: Intermittent Very-Low Calorie Diet
Severely restrict calorie intake intermittently

研究工具

Active Comparator: Continuous Calorie Restriction
Daily calorie restriction: follow low-calorie diet (1,200-1,500 calories) daily using portion-controlled meals
Experimental: Intermittent Very-Low Calorie Diet
Intermittent Restriction: follow very-low calorie diet (500-800) with portion-controlled meals three days per week and structured healthy eating on other days

招募信息

招募状态 ^ICMJE

Active, not recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 2018

预计主要完成日期

October 2018 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: 1. Age 21-65 years. 2. BMI 25-35. Patients with a BMI less than 25 are not classified as overweight and individuals with a BMI >35 may require more aggressive weight management strategies. 3. Clearance for participation from their PCP. Exclusion Criteria: 1. Participation in a research project or formal program involving weight loss or exercise in the previous 6 mos., as these proximal experiences may impact the results of this study. 2. Participation in a regular exercise program (i.e., > 500 kcal/wk. of planned activity as estimated by questionnaire [34]. 3. Not weight stable (-/+ 5%) for 6 mos. prior to intake. This will be determined by phone screen and self-report on the health history questionnaire 4. Unwilling to be randomized to one of two diet strategies for weight loss. 5. Pregnant during the previous 6 mos., lactating, or planned pregnancy in the following 6 mos. 6. Serious medical risk (e.g. diabetes, cancer, cardiovascular disease) as determined by the individual's physician via the clearance to participate in the investigation. 7. Disordered eating as determined by the Eating Attitudes Test using a score of 20 or greater [35]. This score indicates the need for counseling outside the scope of this study. 8. Current treatment for psychological problems, or taking psychotropic medications. Addressing psychological problems is outside the scope of this study. 9. Medications known to significantly influence weight. 10. Adherence to specialized diet regimens (e.g., multiple food allergies, vegan, etc.) 11. Do not have access to or independence over grocery shopping and meal preparation (i.e. those in military, college with cafeteria plan, etc.). 12. If participants have recently undergone CT (Computed Tomography), PET, fluoroscopic, or nuclear medicine studies within the past year.

性别

参与研究的性别:

All

年龄

最小年龄：21 Years ，最大年龄：65 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Undecided

责任方

Debra K. Sullivan, PhD, RD，University of Kansas Medical Center

研究赞助商 ^ICMJE

University of Kansas Medical Center

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Debra Sullivan, PhD, RD University of Kansas Medical Center

PRS 账户

University of Kansas Medical Center

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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