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临床试验/NCT04372771
NCT04372771已完成不适用

Comparison of Two Diet and Exercise Approaches on Weight Loss and Health Outcomes in Obese Women

Texas A&M University0 个研究点目标入组 120 人开始时间: 2010年4月19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
120
主要终点
Body Composition: Lean Mass

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Participant is female
  • Participant is between the ages of 18 and 45
  • Participant is sedentary and overweight (BMI > 27)

排除标准

  • 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).

结局指标

主要结局

Body Composition: Lean Mass

时间窗: 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)

Body Composition: Body Weight

时间窗: 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)

Body Composition: Fat Mass

时间窗: 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)

Energy Homeostasis: Resting Energy Expenditure (REE)

时间窗: 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)

Body Composition: Percent Body Fat

时间窗: 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)

次要结局

  • Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test(Measured prior to supplementation (Pre), and after 16 weeks)
  • Hormones: Leptin(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Lipid Panel: HDL Cholesterol(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Lipid Panel: LDL Cholesterol(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press(Measured prior to supplementation (Pre), and after 16 weeks)
  • Lipid Panel: Cholesterol:HDL Ratio(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(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Dietary Energy Intake: Carbohydrate(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press(Measured prior to supplementation (Pre), and after 16 weeks)
  • Lipid Panel: Triglycerides(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Hormones: Insulin(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Anthropometric Measures: Waist Circumference(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Anthropometric Measures: Waist to Hip Ratio(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Exercise Capacity: Peak Exercise Capacity (VO2)(Measured prior to supplementation (Pre), and after 16 weeks)
  • Dietary Energy Intake: Protein(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test(Measured prior to supplementation (Pre), and after 16 weeks)
  • Lipid Panel: Cholesterol(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Comprehensive Metabolic Panel (CMP): Glucose(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Hemodynamic Variable: Resting Heart Rate (HR)(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Anthropometric Measures: Hip Circumference(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Exercise Capacity: Time to Peak Exercise Capacity (time to peak VO2)(Measured prior to supplementation (Pre), and after 16 weeks)
  • Dietary Energy Intake: Total Caloric Intake (kcals/d)(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Hemodynamic Variable: Resting Diastolic Blood Pressure (SBP)(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)
  • Dietary Energy Intake: Fat(Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks)

研究者

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

Richard B. Kreider

Executive Director, Human Clinical Research Facility

Texas A&M University

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