Comparing Diet and Exercise Approaches in Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diet Modification

Intervention / Treatment
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* Other: Curves Circuit
* Other: Weight Watchers


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No diet or exercise intervention | |
| Experimental: Curves Program<br>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. | Other: Curves Circuit<br>* 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.<br>|
| Experimental: Weight Watchers Momentum Program<br>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. | Other: Weight Watchers<br>* The Weight Watchers program encourages one to increase physical activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition: Body Weight | 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 | 
| Body Composition: Fat Mass | 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 | 
| Body Composition: Lean Mass | 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 | 
| Body Composition: Percent Body Fat | 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 | 
| Energy Homeostasis: Resting Energy Expenditure (REE) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press | 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 | 
| Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press | 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 | 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 | 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 | 
| Lipid Panel: Cholesterol | 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 | 
| Lipid Panel: HDL Cholesterol | 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 | 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 | 
| Lipid Panel: Triglycerides | 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 | 
| Lipid Panel: Cholesterol:HDL Ratio | 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 | 
| Comprehensive Metabolic Panel (CMP): Glucose | 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 | 
| Hormones: Insulin | 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 | 
| Hormones: Leptin | 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 | 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) | 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) | 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 | 
| Hemodynamic Variable: Resting Diastolic Blood Pressure (SBP) | 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 | 
| Anthropometric Measures: Waist Circumference | 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 | 
| Anthropometric Measures: Hip Circumference | 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 | 
| Anthropometric Measures: Waist to Hip Ratio | 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 | 
| Exercise Capacity: Peak Exercise Capacity (VO2) | 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 | 
| Exercise Capacity: Time to Peak Exercise Capacity (time to peak VO2) | 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 | 
| Dietary Energy Intake: Total Caloric Intake (kcals/d) | 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 | 
| Dietary Energy Intake: Carbohydrate | 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 | 
| Dietary Energy Intake: Fat | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise Intervention