Comparing Diet and Exercise Approaches in Women (CWW)
2020年4月30日 更新者：Richard B. Kreider、Texas A&M University
Comparison of Two Diet and Exercise Approaches on Weight Loss and Health Outcomes in Obese Women
The purpose of this study is to determine whether following a Curves high protein/low fat diet (30% carbohydrate, 45% protein, 25% fat) for 30-days several times during 16 weeks of participating in the Curves fitness program promotes stepwise reductions in body weight, improvements in body composition and/or improvements in markers of fitness and health better than following the Weight Watchers Momentum Program for the same time period.
研究概览
详细说明
The Curves International fitness and weight loss program has become a very popular means of promoting health and fitness among women.
The program involves a 30-minute circuit training program and a weight management program involving periods of moderate caloric restriction (1,200 to 1,600 calories per day) followed by short periods of higher caloric intake (2,600 calories per day).
The program is designed to promote a gradual reduction in body fat while increasing strength and muscle mass/tone.
Researchers in the Exercise and Sport Nutrition Lab at Texas A&M University have conducted an extensive study on the effectiveness and safety of the Curves fitness and diet program.
Results of this initial study have shown that the program promotes weight loss, improves markers of health, and improves fitness.
The Weight Watchers program is another popular weight loss program.
It provides a systematic approach to diet and exercise throughout the weight-loss process.
Consequently we are interested in comparing the efficacy of both programs to one another.
The purpose of this study is to determine whether following a Curves high protein/low fat diet (30% carbohydrate, 45% protein, 25% fat) for 30-days several times during 16 weeks of participating in the Curves fitness program promotes stepwise reductions in body weight, improvements in body composition and/or improvements in markers of fitness and health better than following the Weight Watchers Momentum Program for the same time period.
研究类型
介入性
注册 (实际的)
120
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 45年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Participant is female
- Participant is between the ages of 18 and 45
- Participant is sedentary and overweight (BMI > 27)
Exclusion Criteria:
- Participant has any metabolic disorder including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism;
- Participant has a history of hypertension, hepatorenal, musculoskeletal, autoimmune or neurological disease;
- Participant is taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications;
- Participant has been pregnant or lactating within the past 12 months or are planning to become pregnant during the next 12 months;
- Participant is involved in a planned exercise program (> 30 min./d. 3 d./wk.) within 3 - 6 months prior to the start of the study;
- Participant has taken any weight loss medications and/or dietary supplements that may affect muscle mass or body weight during the three month time period prior to beginning the study;
- Participant has a recent history of weight change (+/- 7 lbs. within the last 3 months).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Control
No diet or exercise intervention
|
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实验性的：Curves Program
The Curves group will follow the high protein/low fat diet (30% carbohydrate, 45% protein, 25% fat) for 7-days at 1,200 kcals/day and then 1,500 kcals/day for the remaining 21-days of the 30-day diet period.
The participants will then consume a normal maintenance diet (2,200 kcals/d; 45% carbohydrate, 30% protein, 25% fat) for 30-days.
During the maintenance period, participants will diet for 2-days at 1,200 kcals/day if they gain 3 pounds of weight.
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The Curves Circuit consists performing 13 hydraulic resistance exercise machines that utilize bidirectional resistance that work all major muscle groups.
These are interspersed with floor-based calisthenic exercises designed to maintain an elevated heart rate.
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实验性的：Weight Watchers Momentum Program
This program is based on the Weight Watchers four pillar approach (food, exercise, behavior and support).
The Momentum Program uses POINTS values to help keep track of what you eat.
A POINTS "budget" will be personalized for you at the weekly meetings.
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The Weight Watchers program encourages one to increase physical activity.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body Composition: Body Weight
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in body weight (lbs.
body weight) obtained via digital scale and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Body Composition: Fat Mass
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in body composition (lbs.
fat mass) obtained via Dual-Energy X-Ray Absorptiometry (DXA) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Body Composition: Lean Mass
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in body composition (lbs.
lean mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Body Composition: Percent Body Fat
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in body composition (% body fat) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Energy Homeostasis: Resting Energy Expenditure (REE)
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in REE obtained via metabolic cart and expressed in absolute (kcal/d) and relative terms (kcals/kg/d) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press
大体时间：Measured prior to supplementation (Pre), and after 16 weeks
|
Changes in bench press 1 Repetition Maximum (1RM) obtained from a bench press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 16 weeks
|
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Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press
大体时间：Measured prior to supplementation (Pre), and after 16 weeks
|
Changes in leg press 1RM obtained from a leg press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 16 weeks
|
|
Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test
大体时间：Measured prior to supplementation (Pre), and after 16 weeks
|
Changes in total repetitions at 80% of 1RM obtained from a bench press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 16 weeks
|
|
Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test
大体时间：Measured prior to supplementation (Pre), and after 16 weeks
|
Changes in total repetitions at 80% of 1RM obtained from a leg press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 16 weeks
|
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Lipid Panel: Cholesterol
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Lipid Panel: HDL Cholesterol
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in HDL cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
|
Lipid Panel: LDL Cholesterol
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in LDL cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Lipid Panel: Triglycerides
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in triglycerides obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Lipid Panel: Cholesterol:HDL Ratio
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in cholesterol to HDL cholesterol ratio obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Comprehensive Metabolic Panel (CMP): Glucose
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in glucose obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Hormones: Insulin
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in insulin obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Hormones: Leptin
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in leptin obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
|
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR): Homeostatic Model Assessment of Insulin Resistance
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in HOMA-IR obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
|
Hemodynamic Variable: Resting Heart Rate (HR)
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in resting heart rate (HR) obtained via a blood pressure meter and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
|
Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in resting systolic blood pressure (SBP) obtained via a blood pressure meter and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Hemodynamic Variable: Resting Diastolic Blood Pressure (SBP)
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in resting diastolic blood pressure (DBP) obtained via a blood pressure meter and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Anthropometric Measures: Waist Circumference
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in waist circumference obtained via tape measure and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Anthropometric Measures: Hip Circumference
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in hip circumference obtained via tape measure and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Anthropometric Measures: Waist to Hip Ratio
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in the ratio of waist to hip (waist/hip circumference) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Exercise Capacity: Peak Exercise Capacity (VO2)
大体时间：Measured prior to supplementation (Pre), and after 16 weeks
|
Changes in exercise capacity (VO2 max) obtained via a treadmill test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 16 weeks
|
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Exercise Capacity: Time to Peak Exercise Capacity (time to peak VO2)
大体时间：Measured prior to supplementation (Pre), and after 16 weeks
|
Changes in exercise capacity (time to peak VO2 max) obtained via a treadmill test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 16 weeks
|
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Dietary Energy Intake: Total Caloric Intake (kcals/d)
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in caloric/energy intake (kcals/d) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Dietary Energy Intake: Carbohydrate
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in dietary carbohydrate intake (g/d and g/kg/d) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Dietary Energy Intake: Fat
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in dietary fat intake (g/d and g/kg/d) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
|
Dietary Energy Intake: Protein
大体时间：Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in dietary protein intake (g/d and g/kg/d) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Richard B Kreider, PhD、Texas A&M University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2010年4月19日
初级完成 (实际的)
2012年3月22日
研究完成 (实际的)
2012年3月22日
研究注册日期
首次提交
2020年4月30日
首先提交符合 QC 标准的
2020年4月30日
首次发布 (实际的)
2020年5月4日
研究记录更新
最后更新发布 (实际的)
2020年5月4日
上次提交的符合 QC 标准的更新
2020年4月30日
最后验证
2020年4月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- IRB2010-0130F
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
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