- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00030160
Strength Training for Obesity Prevention
12 gennaio 2010 aggiornato da: 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione
160
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55454
- University of Minnesota, Division of Epidemiology
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 25 anni a 44 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Femmina
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2002
Completamento dello studio
1 luglio 2005
Date di iscrizione allo studio
Primo inviato
7 febbraio 2002
Primo inviato che soddisfa i criteri di controllo qualità
7 febbraio 2002
Primo Inserito (Stima)
8 febbraio 2002
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
13 gennaio 2010
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 gennaio 2010
Ultimo verificato
1 gennaio 2010
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Schmitzm (completed)
- 1R01DK060743-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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