Lifestyle Intervention for Pakistani Women in Oslo (InnvaDiab)
Evaluation of a Lifestyle Intervention to Prevent Type 2 Diabetes/Metabolic Syndrome Among Pakistani Immigrants - Focusing on Changes in Diet and Physical Activity
연구 개요
상세 설명
Objectives:
- To evaluate the health effects of systematic dietary education and counselling and physical training in a group of Pakistani women with high risk of type 2 diabetes.
- To evaluate the intervention process in order to identify the most effective methods of intervention in regard to diet and physical activity for immigrant women of Pakistani origin.
Background: Immigrants from South Asia have a high prevalence of type 2 diabetes, which may be prevented by intensive on physical activity and diet. This application concerns intervention with diet and physical activity in female (ongoing study) and male (extended study) Pakistani immigrants living in Oslo to reduce their risk for these diseases.
Intervention design: The subjects will be 200 women randomized into an intervention group and a control group (100 in each). The women are being recruited from a township in Oslo with a high proportion of immigrants by using a network approach. Inclusion criteria is based on a risk score developed by Ramachandran et al for Asian Indians, entailing age, Body Mass Index, waist circumference, family history of diabetes and sedentary physical activity.
The intervention will include a combination of individual counselling and group sessions. The intervention group will be divided into subgroups of 10-12 subjects. Each subgroup will have 10 group sessions on diet/lifestyle in the 6 months the intervention period lasts, and will additionally have the possibility to join a cultural adapted exercise program of low intensity twice a week. This includes indoor activities (exercise with music) and outdoor activities (walking groups).
Evaluation: The main end point of the intervention will be the fasting and 2-h plasma glucose value after an oral glucose tolerance test (OGTT). This will be measured at baseline and after 6 months of intervention.
Secondary end-points will be Serum lipid profile (e.g. triglycerides, High-Density Lipoprotein-cholesterol) ; HbA1c ; C-peptide ; serum insulin; serum albumin; body weight; waist and hip circumference; maximum heart rate on treadmill test; self-reported level of intensity, duration and frequency of physical activity; self-reported level of "Stages of change" in regard to motivation and behavioural change; self- reported subjective health complaints; self-reported coping strategies; self-reported sleeping habits.
Dietary information will be collected by 2 x 48 hours dietary recalls. The intake of energy and nutrients will be calculated from the recalls, as well as the intake of food groups.The diet will also be evaluated by a culturally adapted food frequency questionnaire including 20 food groups (with portion sizes). In addition, the use of cooking oils will be registered by questions about the type and quantity oil used per time unit in the household. Additionally, information on knowledge and perceptions on diet and health before and after the intervention will be registered.
Physical activity will be registered using an advanced continuous body monitor, SenseWear Armband yielding information on total energy expenditure, level of intensity, duration and frequency of physical activity, duration of lying down, duration of sleeping, and sleeping quality.
The completion of the questionnaires will take the form of an interview by Urdu speaking staff.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Holmlia, Oslo
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Oslo, Holmlia, Oslo, 노르웨이, 1255
- Primary Health Care Health Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Risk score developed by Ramachandran et al for Asian Indians:
- BMI, waist circumference, family history of diabetes and sedentary physical activity
Exclusion Criteria:
- Type 1 diabetes.
- Positive auto antibodies.
- Diagnosis of type 2 diabetes more than 6 months.
- Medication for type 2 diabetes.
- Pregnancy at intervention start.
- Suffering from heart attack or stroke the last 3 months.
- Already participating in organised physical exercise.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention
The intervention group was divided into nine subgroups of ten to twelve women who were offered six educational sessions, each lasting 2 h, during a 7 +- 1-month period.
The main focus was on the physiological importance of blood glucose and its regulation by diet and physical activity, and on knowledge about the Pakistani lifestyle in Pakistan and Norway
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The intervention will include a combination of individual counselling group sessions.
The intervention groups will be divided into subgroups of 10-12 subjects.
Each group will have 10 group sessions on diet/lifestyle in the 6 months the intervention period lasts, and will additionally have the possibility to join a culturally adapted exercise program of low intensity twice a week.
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간섭 없음: Control
One lesson recieved after post-test
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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The Fasting Plasma Glucose Value, Baseline
기간: baseline
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baseline
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Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
기간: baseline
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baseline
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The Fasting Plasma Glucose, Post-test
기간: post-test
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post-test
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Plasma Glucose, 2-h, Post-test
기간: post-test
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post-test
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2차 결과 측정
결과 측정 |
기간 |
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HbA1c, Baseline
기간: baseline
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baseline
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C-peptide, 0-h, Baseline
기간: baseline
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baseline
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C-peptid, 2-h, Baseline
기간: baseline
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baseline
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Insulin, 0-h, Baseline
기간: baseline
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baseline
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Insulin, 2-h, Baseline
기간: baseline
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baseline
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High-Density Lipoprotein Cholesterol, Baseline
기간: baseline
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baseline
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Triglycerides, Baseline
기간: baseline
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baseline
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Systolic Blood Pressure, Baseline
기간: baseline
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baseline
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Diastolic Blood Pressure, Baseline
기간: baseline
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baseline
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Waist Circumference, Baseline
기간: baseline
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baseline
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Body Mass Index, Baseline
기간: baseline
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baseline
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Intake of Vegetables, Fruit and Fruit Juice, Baseline
기간: baseline
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baseline
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Intake of Soft Drinks With Added Sugar, Baseline
기간: baseline
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baseline
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Intake of Red Meat, Baseline
기간: baseline
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baseline
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Intake of Poultry, Baseline
기간: baseline
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baseline
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Intake of Fish, Baseline
기간: baseline
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baseline
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HbA1C, Post-test
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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C-peptid, 0-h, Post-test
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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C-peptid, 2-h, Post-test
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Insulin, 0-h, Post-test
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Insulin, 2-h, Post-test
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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High-Density Lipoprotein Cholesterol, Post-test
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Triglycerides, Post-test
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Systolic Blood Pressure, Post-test
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Diastolic Blood Pressure, Post-test
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Waist Circumference
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Body Mass Index, Post-test
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Intake of Vegetables, Fruit and Fruit Juice, Post-test
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Intake of Soft Drinks With Added Sugar, Post-test
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Intake of Red Meat, Post-test
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Intake of Poultry, Post-test
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Intake of Fish, Post Test
기간: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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공동 작업자 및 조사자
수사관
- 수석 연구원: Gerd Holmboe-Ottesen, Dr. Philos., University of Oslo
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. .