- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00030160
Strength Training for Obesity Prevention
12. ledna 2010 aktualizováno: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recent obesity prevalence increases have made obesity prevention a clear and pressing public health issue.
The average US.
woman gains about 0.5 kg per year.
Overweight women aged 25 to 44 have a higher prevalence of significant weight gains (BMI increases of > 5 kg/m2) than men or older or thinner women.
The difficulty in successfully losing weight and maintaining weight loss has resulted in recommendations from several expert panels to advise overweight and mildly obese individuals free of co-morbidities to avoid weight gains rather than to lose weight.
Physical activity is observed to decline with age while caloric intake remains stable or declines slightly.
There is strong observational evidence that physical activity could prevent or attenuate age associated fat gains.
This randomized, controlled behavioral intervention trial will test the hypothesis that regular participation in a twice weekly strength training program over 2 years, can prevent age associated body fat increases (total and abdominal fat) in 80 overweight to mildly obese premenopausal women between the ages of 25 and 44 years, compared to a 'standard care' group (n=80).
The overall aim of the study is to prevent body fat gains and to reduce health risks associated with obesity.
Treatment effects will be assessed for insulin sensitivity, blood pressure, blood lipids, muscle strength, and psychosocial predictors of strength training adherence.
The innovation of this approach rests in its simplicity and the minimal time requirement for full participation (2 exercise sessions weekly).
A preliminary study of this innovative approach resulted in 88% exercise session attendance over 12 months and maintenance of treatment effects on total body fat percentage to the end of pilot study measurements (9 months).
This supports the feasibility and potential for long term efficacy of the proposed intervention approach.
The long-term implication of success in this efficacy trial would be that this modest behavior change could prevent the fat gains and associated co-morbidities commonly observed in midlife women.
Přehled studie
Detailní popis
Recent obesity prevalence increases have made obesity prevention a clear and pressing public health issue.
The average US.
woman gains about 0.5 kg per year, 60 to 80% of which can be assumed to be fat.
Overweight women aged 25 to 44 have a higher prevalence of significant weight gains (BMI increases of > 5 kg/m2) than men or older or thinner women.
Total and visceral abdominal fat gains are associated with a variety of obesity co-morbidities, including insulin resistance, hypertension, and dyslipidemia.
The difficulty in successfully losing weight and maintaining weight loss has resulted in recommendations from several expert panels to advise overweight and mildly obese individuals free of co-morbidities to avoid weight gains rather than to lose weight.
Physical activity is observed to decline with age while caloric intake remains stable or declines slightly.
There is strong observational evidence that physical activity could prevent or attenuate age associated fat gains.
This randomized, controlled behavioral intervention trial will test the hypothesis that regular participation in a twice weekly strength training program over 2 years, can prevent age associated body fat increases (total and visceral abdominal fat) in 80 overweight to mildly obese premenopausal women (BMI 25-35 kg/m2) between the ages of 25 and 44 years, compared to a 'standard care' group (n=80).
The overall aim of the study is to prevent body fat gains and to reduce health risks associated with obesity.
Treatment effects will be assessed for insulin sensitivity, blood pressure, blood lipids, muscle strength, and psychosocial predictors of strength training adherence.
The innovation of this approach rests in its simplicity and the minimal time requirement for full participation (2 exercise sessions weekly).
A preliminary study of this innovative approach resulted in 88% exercise session attendance over 12 months and maintenance of treatment effects on total body fat percentage to the end of pilot study measurements (9 months).
This supports the feasibility and potential for long term efficacy of the proposed intervention approach.
The long-term implication of success in this efficacy trial would be that this modest behavior change could prevent the fat gains and associated co-morbidities commonly observed in midlife women.
Typ studie
Intervenční
Zápis
160
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Minnesota
-
Minneapolis, Minnesota, Spojené státy, 55454
- University of Minnesota, Division of Epidemiology
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
25 let až 44 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Ženský
Popis
Eligible participants will include women between the ages of 25 and 44, BMI between 25 and 35 (inclusive).
Other inclusion/exclusion criteria:
- Weight stable (<5% body weight change over past year)
- No medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims (e.g. fibromyalgia, chronic fatigue syndrome, metabolic disorders, recent cardiovascular event, orthopedic limitations, any drug expected to impact body weight, psychiatric disorders requiring anti-psychotic drugs)
- Uncontrolled hypertension (systolic blood pressure over 160 and/or diastolic blood pressure over 99)
- No history of cancer within the past 5 years, excepting non-melanoma skin cancers
- Not currently or recently (past 6 months) pregnant
- Not planning to become pregnant during the study period
- Not currently or recently (past 2 months) lactating
- No history of physician diagnosed menstrual irregularities or significant gynecologic conditions (e.g. fibroids, endometriosis)
- Pre-menopausal
- Current non-smokers (for at least the past 2 years)
- Sedentary to modestly physically active (up to 3 sessions weekly of physical activity of no greater intensity than brisk walking) with no history of strength training within the past 6 months
- Not planning to move away from the Twin Cities area over the next 2 years
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. dubna 2002
Dokončení studie
1. července 2005
Termíny zápisu do studia
První předloženo
7. února 2002
První předloženo, které splnilo kritéria kontroly kvality
7. února 2002
První zveřejněno (Odhad)
8. února 2002
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
13. ledna 2010
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. ledna 2010
Naposledy ověřeno
1. ledna 2010
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Schmitzm (completed)
- 1R01DK060743-01 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Strength Training
-
Trinitas Comprehensive Cancer CenterAptium Oncology Research NetworkNeznámýRakovina prsuSpojené státy
-
Florida State UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH)Dokončeno
-
Appalachian State UniversityHerbalife International of America, Inc.Dokončeno
-
Pernille Louise KjeldsenUniversity of Aarhus; Innovation Fund Denmark; Brain+ ApS; Eurostars EUREKAZatím nenabírámeMírná kognitivní poruchaDánsko
-
Cambridge Health AllianceNational Institute of General Medical Sciences (NIGMS); Healing Lodge of the...Zápis na pozvánkuPoruchy související s látkami | Duševní zdravíSpojené státy
-
Wake Forest UniversityNáborSarkopenieSpojené státy
-
Riphah International UniversityNáborVysoce intenzivní intervalový trénink | Funkční výkon | Fotbaloví hráčiPákistán
-
University of ManitobaDokončeno
-
Rockefeller UniversityNáborStres, psychologický | RasismusSpojené státy