Comparing Diet and Exercise Approaches in Women (CWW)
30. april 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
120
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 45 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Control
No diet or exercise intervention
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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Body Composition: Body Weight
Tidsramme: 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)
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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
Tidsramme: 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
|
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Body Composition: Lean Mass
Tidsramme: 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
Tidsramme: 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
|
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Energy Homeostasis: Resting Energy Expenditure (REE)
Tidsramme: 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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press
Tidsramme: 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
|
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Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press
Tidsramme: 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
|
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Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test
Tidsramme: 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
Tidsramme: 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
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Lipid Panel: Cholesterol
Tidsramme: 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
|
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Lipid Panel: HDL Cholesterol
Tidsramme: 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
|
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Lipid Panel: LDL Cholesterol
Tidsramme: 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
|
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Lipid Panel: Triglycerides
Tidsramme: 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
|
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Lipid Panel: Cholesterol:HDL Ratio
Tidsramme: 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
|
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Comprehensive Metabolic Panel (CMP): Glucose
Tidsramme: 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
Tidsramme: 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
|
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Hormones: Leptin
Tidsramme: 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
|
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Homeostatic Model Assessment of Insulin Resistance (HOMA-IR): Homeostatic Model Assessment of Insulin Resistance
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
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Anthropometric Measures: Waist Circumference
Tidsramme: 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
|
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Anthropometric Measures: Hip Circumference
Tidsramme: 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
Tidsramme: 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)
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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)
Tidsramme: 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
|
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Exercise Capacity: Time to Peak Exercise Capacity (time to peak VO2)
Tidsramme: 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
|
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Dietary Energy Intake: Total Caloric Intake (kcals/d)
Tidsramme: 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
Tidsramme: 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)
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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
Tidsramme: 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
Tidsramme: 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)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Richard B Kreider, PhD, Texas A&M University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. april 2010
Primær fullføring (Faktiske)
22. mars 2012
Studiet fullført (Faktiske)
22. mars 2012
Datoer for studieregistrering
Først innsendt
30. april 2020
Først innsendt som oppfylte QC-kriteriene
30. april 2020
Først lagt ut (Faktiske)
4. mai 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. mai 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. april 2020
Sist bekreftet
1. april 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- IRB2010-0130F
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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