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Comparing Diet and Exercise Approaches in Women (CWW)

30 kwietnia 2020 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

120

Faza

  • Nie dotyczy

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 45 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Control
No diet or exercise intervention
Eksperymentalny: 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.
Inny: 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.
Eksperymentalny: 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.
Inny: Weight Watchers
The Weight Watchers program encourages one to increase physical activity.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Body Composition: Body Weight
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Texas A&M University

Śledczy

  • Główny śledczy: Richard B Kreider, PhD, Texas A&M University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

19 kwietnia 2010

Zakończenie podstawowe (Rzeczywisty)

22 marca 2012

Ukończenie studiów (Rzeczywisty)

22 marca 2012

Daty rejestracji na studia

Pierwszy przesłany

30 kwietnia 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 kwietnia 2020

Pierwszy wysłany (Rzeczywisty)

4 maja 2020

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 maja 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 kwietnia 2020

Ostatnia weryfikacja

1 kwietnia 2020

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • IRB2010-0130F

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Nie

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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