Comparing Diet and Exercise Approaches in Women (CWW)
30 april 2020 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
120
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 45 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Control
No diet or exercise intervention
|
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Body Composition: Body Weight
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Richard B Kreider, PhD, Texas A&M University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
19 april 2010
Primärt slutförande (Faktisk)
22 mars 2012
Avslutad studie (Faktisk)
22 mars 2012
Studieregistreringsdatum
Först inskickad
30 april 2020
Först inskickad som uppfyllde QC-kriterierna
30 april 2020
Första postat (Faktisk)
4 maj 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 maj 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 april 2020
Senast verifierad
1 april 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- IRB2010-0130F
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .