Comparing Diet and Exercise Approaches in Women

Diet Modification Clinical Trial

— CWW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04372771
• Other study ID #: IRB2010-0130F
• Status: Completed
• Phase: N/A
• Start date: April 19, 2010
• Est. completion date: March 22, 2012

Study information

• Verified date: April 2020
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 22, 2012
• Est. primary completion date: March 22, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diet Modification

Intervention

Other:
• Curves 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.
• Weight Watchers
The Weight Watchers program encourages one to increase physical activity.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Texas A&M University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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