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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Holmlia, Oslo
-
Oslo, Holmlia, Oslo, Noruega, 1255
- Primary Health Care Health Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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
|
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.
|
|
Sem intervenção: Control
One lesson recieved after post-test
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
The Fasting Plasma Glucose Value, Baseline
Prazo: baseline
|
baseline
|
|
Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
Prazo: baseline
|
baseline
|
|
The Fasting Plasma Glucose, Post-test
Prazo: post-test
|
post-test
|
|
Plasma Glucose, 2-h, Post-test
Prazo: post-test
|
post-test
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
HbA1c, Baseline
Prazo: baseline
|
baseline
|
|
C-peptide, 0-h, Baseline
Prazo: baseline
|
baseline
|
|
C-peptid, 2-h, Baseline
Prazo: baseline
|
baseline
|
|
Insulin, 0-h, Baseline
Prazo: baseline
|
baseline
|
|
Insulin, 2-h, Baseline
Prazo: baseline
|
baseline
|
|
High-Density Lipoprotein Cholesterol, Baseline
Prazo: baseline
|
baseline
|
|
Triglycerides, Baseline
Prazo: baseline
|
baseline
|
|
Systolic Blood Pressure, Baseline
Prazo: baseline
|
baseline
|
|
Diastolic Blood Pressure, Baseline
Prazo: baseline
|
baseline
|
|
Waist Circumference, Baseline
Prazo: baseline
|
baseline
|
|
Body Mass Index, Baseline
Prazo: baseline
|
baseline
|
|
Intake of Vegetables, Fruit and Fruit Juice, Baseline
Prazo: baseline
|
baseline
|
|
Intake of Soft Drinks With Added Sugar, Baseline
Prazo: baseline
|
baseline
|
|
Intake of Red Meat, Baseline
Prazo: baseline
|
baseline
|
|
Intake of Poultry, Baseline
Prazo: baseline
|
baseline
|
|
Intake of Fish, Baseline
Prazo: baseline
|
baseline
|
|
HbA1C, Post-test
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
|
C-peptid, 0-h, Post-test
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
|
C-peptid, 2-h, Post-test
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
|
Insulin, 0-h, Post-test
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
|
Insulin, 2-h, Post-test
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
|
High-Density Lipoprotein Cholesterol, Post-test
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
|
Triglycerides, Post-test
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
|
Systolic Blood Pressure, Post-test
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
|
Diastolic Blood Pressure, Post-test
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
|
Waist Circumference
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
|
Body Mass Index, Post-test
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
|
Intake of Vegetables, Fruit and Fruit Juice, Post-test
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
|
Intake of Soft Drinks With Added Sugar, Post-test
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
|
Intake of Red Meat, Post-test
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
|
Intake of Poultry, Post-test
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
|
Intake of Fish, Post Test
Prazo: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gerd Holmboe-Ottesen, Dr. Philos., University of Oslo
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NFR 166998/166977
- EU-DEPLAN 2004310
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .