- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Taichung, 대만
- Department of Famility Medicine,China Medical University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Individualized education
Individualized consultation of health problem, dietary intake and exercise
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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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실험적: Grouped education
Grouped consultation of health problem, dietary intake and exercise
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Weight, BMI, total body fat and waist circumference
기간: 3,6 and 12 months since intervention
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3,6 and 12 months since intervention
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2차 결과 측정
결과 측정 |
기간 |
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Metabolic syndrome and its components
기간: 3,6 and 12 months since intervention
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3,6 and 12 months since intervention
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공동 작업자 및 조사자
수사관
- 연구 의자: Cheng-Chieh Lin, Ph.D., China Medical University Hospital,Taiwan
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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