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Comparing Diet and Exercise Approaches in Women (CWW)

30 aprile 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

120

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 45 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Control
No diet or exercise intervention
Sperimentale: 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.
Altro: 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.
Sperimentale: 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.
Altro: Weight Watchers
The Weight Watchers program encourages one to increase physical activity.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Body Composition: Body Weight
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Body Composition: Fat Mass
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Body Composition: Lean Mass
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Body Composition: Percent Body Fat
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Energy Homeostasis: Resting Energy Expenditure (REE)
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 16 weeks
Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 16 weeks
Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 16 weeks
Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 16 weeks
Lipid Panel: Cholesterol
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Lipid Panel: HDL Cholesterol
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Lipid Panel: LDL Cholesterol
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Lipid Panel: Triglycerides
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Lipid Panel: Cholesterol:HDL Ratio
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Comprehensive Metabolic Panel (CMP): Glucose
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Hormones: Insulin
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Hormones: Leptin
Lasso di tempo: 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)
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
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Hemodynamic Variable: Resting Heart Rate (HR)
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Hemodynamic Variable: Resting Diastolic Blood Pressure (SBP)
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Anthropometric Measures: Waist Circumference
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Anthropometric Measures: Hip Circumference
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Anthropometric Measures: Waist to Hip Ratio
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Exercise Capacity: Peak Exercise Capacity (VO2)
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 16 weeks
Exercise Capacity: Time to Peak Exercise Capacity (time to peak VO2)
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 16 weeks
Dietary Energy Intake: Total Caloric Intake (kcals/d)
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Dietary Energy Intake: Carbohydrate
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Dietary Energy Intake: Fat
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
Dietary Energy Intake: Protein
Lasso di tempo: 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)
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Texas A&M University

Investigatori

  • Investigatore principale: Richard B Kreider, PhD, Texas A&M University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 aprile 2010

Completamento primario (Effettivo)

22 marzo 2012

Completamento dello studio (Effettivo)

22 marzo 2012

Date di iscrizione allo studio

Primo inviato

30 aprile 2020

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2020

Primo Inserito (Effettivo)

4 maggio 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 aprile 2020

Ultimo verificato

1 aprile 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • IRB2010-0130F

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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