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OpenTrials
Completed

NCT Number: NCT04372771

Comparing Diet and Exercise Approaches in 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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Curves Circuit

Other

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

Other

The Weight Watchers program encourages one to increase physical activity.

Primary outcomes

  1. Body Composition: Body Weight

    Time frame: 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)

  2. Body Composition: Fat Mass

    Time frame: 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)

  3. Body Composition: Lean Mass

    Time frame: 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)

  4. Body Composition: Percent Body Fat

    Time frame: 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)

  5. Energy Homeostasis: Resting Energy Expenditure (REE)

    Time frame: 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 outcomes

  1. Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press

    Time frame: 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)

  2. Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press

    Time frame: 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)

  3. Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test

    Time frame: 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)

  4. Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test

    Time frame: 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)

  5. Lipid Panel: Cholesterol

    Time frame: 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)

  6. Lipid Panel: HDL Cholesterol

    Time frame: 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)

  7. Lipid Panel: LDL Cholesterol

    Time frame: 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)

  8. Lipid Panel: Triglycerides

    Time frame: 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)

  9. Lipid Panel: Cholesterol:HDL Ratio

    Time frame: 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)

  10. Comprehensive Metabolic Panel (CMP): Glucose

    Time frame: 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)

  11. Hormones: Insulin

    Time frame: 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)

  12. Hormones: Leptin

    Time frame: 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)

  13. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR): Homeostatic Model Assessment of Insulin Resistance

    Time frame: 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)

  14. Hemodynamic Variable: Resting Heart Rate (HR)

    Time frame: 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)

  15. Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)

    Time frame: 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)

  16. Hemodynamic Variable: Resting Diastolic Blood Pressure (SBP)

    Time frame: 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)

  17. Anthropometric Measures: Waist Circumference

    Time frame: 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)

  18. Anthropometric Measures: Hip Circumference

    Time frame: 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)

  19. Anthropometric Measures: Waist to Hip Ratio

    Time frame: 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)

  20. Exercise Capacity: Peak Exercise Capacity (VO2)

    Time frame: 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)

  21. Exercise Capacity: Time to Peak Exercise Capacity (time to peak VO2)

    Time frame: 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)

  22. Dietary Energy Intake: Total Caloric Intake (kcals/d)

    Time frame: 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)

  23. Dietary Energy Intake: Carbohydrate

    Time frame: 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)

  24. Dietary Energy Intake: Fat

    Time frame: 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)

  25. Dietary Energy Intake: Protein

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

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

Acronym: CWW

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 4, 2020
Registry last updated
May 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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