Diet Modification
Conditions
Keywords
Exercise Intervention
Brief summary
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
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.
Interventions
OTHERCurves Circuit
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.
OTHERWeight Watchers
The Weight Watchers program encourages one to increase physical activity.
Sponsors
Texas A&M University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition: Body Weight | 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 | 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) |
| Body Composition: Lean Mass | 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: Percent Body Fat | 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) |
| Energy Homeostasis: Resting Energy Expenditure (REE) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid Panel: HDL Cholesterol | 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) |
| Lipid Panel: LDL Cholesterol | 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) |
| Lipid Panel: Triglycerides | 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) |
| Lipid Panel: Cholesterol:HDL Ratio | 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) |
| Comprehensive Metabolic Panel (CMP): Glucose | 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) |
| Hormones: Insulin | 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) |
| Hormones: Leptin | 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) |
| 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 | 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) |
| Hemodynamic Variable: Resting Heart Rate (HR) | 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) |
| Hemodynamic Variable: Resting Systolic Blood Pressure (SBP) | 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) |
| Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press | 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) |
| Anthropometric Measures: Waist Circumference | 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) |
| Anthropometric Measures: Hip Circumference | 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) |
| Anthropometric Measures: Waist to Hip Ratio | 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) |
| Exercise Capacity: Peak Exercise Capacity (VO2) | 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) |
| Exercise Capacity: Time to Peak Exercise Capacity (time to peak VO2) | 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) |
| Dietary Energy Intake: Total Caloric Intake (kcals/d) | 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) |
| Dietary Energy Intake: Carbohydrate | 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) |
| Dietary Energy Intake: Fat | 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) |
| Dietary Energy Intake: Protein | 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) |
| Hemodynamic Variable: Resting Diastolic Blood Pressure (SBP) | 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) |
| Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press | 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) |
| Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test | 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) |
| Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test | 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) |
| Lipid Panel: Cholesterol | 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) |
Outcome results
None listed