- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01040546
The Effect of a Diet- and Exercise- Related Weight Control Intervention Program on Obesity in Adult Aged 40 and Over
The Association of Obesity With Food Intake and Metabolic Syndrome in Adult Aged 40 and Over and the Effect of a Diet- and Exercise- Related Weight Control Intervention Program on Obesity
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Obesity and metabolic syndrome increase the risk of developing cardiovascular disease. Besides, they prevail around the world and certainly become the most important health problems globally. Dietary intake and exercise are regarded as the first line approach to reduce the occurrence of obesity and metabolic syndrome. The purpose of this study is to assess study subjects' adherence to different weight control intervention programs and the effect of intervention programs on physical and biochemical examinations, physical fitness, food intake and exercise behaviors and the prevalence of metabolic syndrome and its components' abnormalities.
This is a two-year project. In the first year, we estimated the prevalence of obesity and metabolic syndrome and explored their relationship with dietary intake and exercise status using the cross-sectional framework in subjects aged 40 years and over from Taichung Community Health Study. Then, we conducted a randomized controlled trial to evaluate the effects of three types of weight control educational intervention programs. Obese subjects were randomly allocated into "individualized health education group", "fellowship health education group" and "mail-delivered health education group". The sample size for these three groups was 79, 81, 80, respectively. All subjects received one of three 6-month interventions and were followed up for 1 year and were assessed at 6-month interval.
This study adopted the criteria of WHO for Asia area and the Department of Health (DOH), Executive Yuan, Taiwan to define the obesity. The prevalence of obesity for WHO definition modified for Asians and DOH among Taichung residents aged forty years old and over is 37.34% and 18.79%, respectively. For the effectiveness of weight control educational programs, after 6-month intervention, reductions in weight, BMI, waist, hip, arm, and bad diet habit were observed in all groups. And after 6-month intervention, reductions in BMI is significantly greater in the individualized and fellowship weight control groups than in the "health education group". After 6-month educational intervention, metabolic syndrome in the individualized and fellowship health education groups decreased from 78.48% and 72.84% to 60.76% and 61.73%, respectively, which corresponded to reductions of 17.72% and 11.11% of baseline metabolic syndrome.
Our study's findings indicate that individualized and fellowship health education groups modify food intake and exercise behaviors, and further reduce body composition, level of biomarkers and prevalence of metabolic syndrome and its components abnormalities.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Taichung, Tchaj-wan
- Department of Famility Medicine,China Medical University Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Those with overweight or central obesity (body mass index >= 24 kg/m2) and/or waist circumference >= 90 cm in men or >= 80 cm in women.
Exclusion Criteria:
- Those with impaired hearing,
- Those who are handicap,
- Those living outland,
- Those who are older than 75 years old, and
- Those participates that cannot keep to regular follow-up in this study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Individualized education
Individualized consultation of health problem, dietary intake and exercise
|
We conducted a randomized controlled trial to evaluate the effects of three types of weight control educational intervention programs.
Obese subjects were randomly allocated into "individualized health education group", "group weight control education" and "mail-delivered health education group".Obese subjects who were randomly allocated into "individualized health education group" received consulting services provided by a doctor, nutritionist and fitness expert.
The interventions were 12 sessions over 6 months.
|
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Experimentální: Grouped education
Grouped consultation of health problem, dietary intake and exercise
|
We conducted a randomized controlled trial to evaluate the effects of three types of weight control educational intervention programs.
Obese subjects were randomly allocated into "individualized health education group", "group weight control education" and "mail-delivered health education group".Obese subjects who were randomly allocated into "grouped health education group" attended 12 sessions of group intervention over 6 months.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Weight, BMI, total body fat and waist circumference
Časové okno: 3,6 and 12 months since intervention
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3,6 and 12 months since intervention
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Metabolic syndrome and its components
Časové okno: 3,6 and 12 months since intervention
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3,6 and 12 months since intervention
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Cheng-Chieh Lin, Ph.D., China Medical University Hospital,Taiwan
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- DOH97-TD-F-113-96002
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 .
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