Comparing Diet and Exercise Approaches in Women (CWW)
30 avril 2020 mis à jour par: Richard B. Kreider, Texas A&M University
Comparison of Two Diet and Exercise Approaches on Weight Loss and Health Outcomes in Obese 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
120
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 45 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
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).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Control
No diet or exercise intervention
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Expérimental: Curves Program
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.
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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.
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Expérimental: Weight Watchers Momentum Program
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.
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The Weight Watchers program encourages one to increase physical activity.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Body Composition: Body Weight
Délai: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Body Composition: Fat Mass
Délai: 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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Body Composition: Lean Mass
Délai: 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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Body Composition: Percent Body Fat
Délai: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Energy Homeostasis: Resting Energy Expenditure (REE)
Délai: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press
Délai: 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)
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Measured prior to supplementation (Pre), and after 16 weeks
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Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press
Délai: Measured prior to supplementation (Pre), and after 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 16 weeks
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Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test
Délai: 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)
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Measured prior to supplementation (Pre), and after 16 weeks
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Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test
Délai: 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)
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Measured prior to supplementation (Pre), and after 16 weeks
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Lipid Panel: Cholesterol
Délai: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Lipid Panel: HDL Cholesterol
Délai: 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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Lipid Panel: LDL Cholesterol
Délai: 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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Lipid Panel: Triglycerides
Délai: 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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Lipid Panel: Cholesterol:HDL Ratio
Délai: 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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Comprehensive Metabolic Panel (CMP): Glucose
Délai: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Hormones: Insulin
Délai: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Hormones: Leptin
Délai: 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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Homeostatic Model Assessment of Insulin Resistance (HOMA-IR): Homeostatic Model Assessment of Insulin Resistance
Délai: 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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Hemodynamic Variable: Resting Heart Rate (HR)
Délai: 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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)
Délai: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Hemodynamic Variable: Resting Diastolic Blood Pressure (SBP)
Délai: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Anthropometric Measures: Waist Circumference
Délai: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Anthropometric Measures: Hip Circumference
Délai: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Anthropometric Measures: Waist to Hip Ratio
Délai: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Exercise Capacity: Peak Exercise Capacity (VO2)
Délai: Measured prior to supplementation (Pre), and after 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 16 weeks
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Exercise Capacity: Time to Peak Exercise Capacity (time to peak VO2)
Délai: Measured prior to supplementation (Pre), and after 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 16 weeks
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Dietary Energy Intake: Total Caloric Intake (kcals/d)
Délai: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Dietary Energy Intake: Carbohydrate
Délai: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Dietary Energy Intake: Fat
Délai: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Dietary Energy Intake: Protein
Délai: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Richard B Kreider, PhD, Texas A&M University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
19 avril 2010
Achèvement primaire (Réel)
22 mars 2012
Achèvement de l'étude (Réel)
22 mars 2012
Dates d'inscription aux études
Première soumission
30 avril 2020
Première soumission répondant aux critères de contrôle qualité
30 avril 2020
Première publication (Réel)
4 mai 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 mai 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 avril 2020
Dernière vérification
1 avril 2020
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IRB2010-0130F
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .