Comparing Diet and Exercise Approaches in Women (CWW)
30 апреля 2020 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
120
Фаза
- Непригодный
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 45 лет (Взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Женский
Описание
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).
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: Control
No diet or exercise intervention
|
|
|
Экспериментальный: 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.
|
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.
|
|
Экспериментальный: 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.
|
The Weight Watchers program encourages one to increase physical activity.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Body Composition: Body Weight
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
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Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
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Hormones: Insulin
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
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Anthropometric Measures: Waist to Hip Ratio
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
|
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Dietary Energy Intake: Carbohydrate
Временное ограничение: 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
|
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Dietary Energy Intake: Fat
Временное ограничение: 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
|
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Dietary Energy Intake: Protein
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Richard B Kreider, PhD, Texas A&M University
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
19 апреля 2010 г.
Первичное завершение (Действительный)
22 марта 2012 г.
Завершение исследования (Действительный)
22 марта 2012 г.
Даты регистрации исследования
Первый отправленный
30 апреля 2020 г.
Впервые представлено, что соответствует критериям контроля качества
30 апреля 2020 г.
Первый опубликованный (Действительный)
4 мая 2020 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
4 мая 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
30 апреля 2020 г.
Последняя проверка
1 апреля 2020 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- IRB2010-0130F
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Нет
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
продукт, произведенный в США и экспортированный из США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .