Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 10:20 PM
Study NCT ID:
NCT00425269
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2007-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lifestyle Intervention for Pakistani Women in Oslo
Sponsor:
Organization:
Raw JSON
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All the teaching was translated into Punjabi, the preferred language of the participants.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Fasting Plasma Glucose Value, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. 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All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.39', 'groupId': 'OG000', 'lowerLimit': '28.3', 'upperLimit': '30.6'}, {'value': '29.73', 'groupId': 'OG001', 'lowerLimit': '28.6', 'upperLimit': '30.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'unitOfMeasure': 'kg/m^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intake of Vegetables, Fruit and Fruit Juice, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. 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All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '328.9', 'groupId': 'OG000', 'lowerLimit': '161', 'upperLimit': '450'}, {'value': '306.3', 'groupId': 'OG001', 'lowerLimit': '193', 'upperLimit': '375'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'unitOfMeasure': 'gram per day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intake of Soft Drinks With Added Sugar, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. 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Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.5'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'unitOfMeasure': 'portions/week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intake of Poultry, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'unitOfMeasure': 'portions/week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intake of Fish, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.97', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '1.3'}, {'value': '0.77', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'unitOfMeasure': 'portions/week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Fasting Plasma Glucose, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.39', 'groupId': 'OG000', 'lowerLimit': '5.24', 'upperLimit': '5.54'}, {'value': '5.66', 'groupId': 'OG001', 'lowerLimit': '5.36', 'upperLimit': '5.95'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Glucose, 2-h, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.00', 'groupId': 'OG000', 'lowerLimit': '7.52', 'upperLimit': '8.48'}, {'value': '8.20', 'groupId': 'OG001', 'lowerLimit': '7.58', 'upperLimit': '8.80'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'HbA1C, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '5.5'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '5.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'percent of Hb', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'C-peptid, 0-h, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '878.5', 'groupId': 'OG000', 'lowerLimit': '809.0', 'upperLimit': '948.1'}, {'value': '914.6', 'groupId': 'OG001', 'lowerLimit': '837.8', 'upperLimit': '991.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'pmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'C-peptid, 2-h, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '3618.1', 'groupId': 'OG000', 'lowerLimit': '3297.8', 'upperLimit': '3938.3'}, {'value': '3439.9', 'groupId': 'OG001', 'lowerLimit': '3096.4', 'upperLimit': '3783.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'pmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Insulin, 0-h, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '121.8', 'groupId': 'OG000', 'lowerLimit': '110.6', 'upperLimit': '133.1'}, {'value': '123.3', 'groupId': 'OG001', 'lowerLimit': '112.1', 'upperLimit': '134.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'pmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Insulin, 2-h, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '861.8', 'groupId': 'OG000', 'lowerLimit': '660.8', 'upperLimit': '1062.8'}, {'value': '786.1', 'groupId': 'OG001', 'lowerLimit': '615.2', 'upperLimit': '957.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'pmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'High-Density Lipoprotein Cholesterol, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.24', 'groupId': 'OG000', 'lowerLimit': '1.17', 'upperLimit': '1.30'}, {'value': '1.20', 'groupId': 'OG001', 'lowerLimit': '1.14', 'upperLimit': '1.26'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Triglycerides, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '1.5'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '1.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '114.4', 'groupId': 'OG000', 'lowerLimit': '111.0', 'upperLimit': '117.7'}, {'value': '117.1', 'groupId': 'OG001', 'lowerLimit': '114.0', 'upperLimit': '120.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000', 'lowerLimit': '76.4', 'upperLimit': '80.8'}, {'value': '80.1', 'groupId': 'OG001', 'lowerLimit': '77.9', 'upperLimit': '82.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '97.9'}, {'value': '96.8', 'groupId': 'OG001', 'lowerLimit': '94.5', 'upperLimit': '99.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'cm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Mass Index, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.11', 'groupId': 'OG000', 'lowerLimit': '28.0', 'upperLimit': '30.3'}, {'value': '29.65', 'groupId': 'OG001', 'lowerLimit': '28.5', 'upperLimit': '30.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'kg/m^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intake of Vegetables, Fruit and Fruit Juice, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '375.4', 'groupId': 'OG000', 'lowerLimit': '193', 'upperLimit': '493'}, {'value': '328.3', 'groupId': 'OG001', 'lowerLimit': '193', 'upperLimit': '450'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'grams per day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intake of Soft Drinks With Added Sugar, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.8'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '5.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'dl/week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intake of Red Meat, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'portions/week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intake of Poultry, Post-test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.5'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'portions/week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intake of Fish, Post Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.5'}, {'value': '1.11', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post-test, after completion of all six group sessions', 'unitOfMeasure': 'portions/week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'moved or medical reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'A multi-recruitment strategy included visits to mosques and other formal and informal gatherings in the local community, as well as word of mouth. Interested women came to an appointment at the local mother and baby health care centre where the intervention took place. An Urdu-speaking research assistant was in charge of the recruitment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.\n\nThe group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Norway', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Years of residence in Norway', 'classes': [{'categories': [{'measurements': [{'value': '18', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '19', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '19', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Years of education', 'classes': [{'categories': [{'measurements': [{'value': '9', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '9', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '9', 'spread': '4.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '29.8', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '29.6', 'spread': '5.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Women, aged 18-65 years, more than 50 percent rated their command of the Norwegian language as poor, and mean number of years of education was 9.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-24', 'studyFirstSubmitDate': '2007-01-19', 'resultsFirstSubmitDate': '2014-04-11', 'studyFirstSubmitQcDate': '2007-01-19', 'lastUpdatePostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-24', 'studyFirstPostDateStruct': {'date': '2007-01-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Fasting Plasma Glucose Value, Baseline', 'timeFrame': 'baseline'}, {'measure': 'Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline', 'timeFrame': 'baseline'}, {'measure': 'The Fasting Plasma Glucose, Post-test', 'timeFrame': 'post-test'}, {'measure': 'Plasma Glucose, 2-h, Post-test', 'timeFrame': 'post-test'}], 'secondaryOutcomes': [{'measure': 'HbA1c, Baseline', 'timeFrame': 'baseline'}, {'measure': 'C-peptide, 0-h, Baseline', 'timeFrame': 'baseline'}, {'measure': 'C-peptid, 2-h, Baseline', 'timeFrame': 'baseline'}, {'measure': 'Insulin, 0-h, Baseline', 'timeFrame': 'baseline'}, {'measure': 'Insulin, 2-h, Baseline', 'timeFrame': 'baseline'}, {'measure': 'High-Density Lipoprotein Cholesterol, Baseline', 'timeFrame': 'baseline'}, {'measure': 'Triglycerides, Baseline', 'timeFrame': 'baseline'}, {'measure': 'Systolic Blood Pressure, Baseline', 'timeFrame': 'baseline'}, {'measure': 'Diastolic Blood Pressure, Baseline', 'timeFrame': 'baseline'}, {'measure': 'Waist Circumference, Baseline', 'timeFrame': 'baseline'}, {'measure': 'Body Mass Index, Baseline', 'timeFrame': 'baseline'}, {'measure': 'Intake of Vegetables, Fruit and Fruit Juice, Baseline', 'timeFrame': 'baseline'}, {'measure': 'Intake of Soft Drinks With Added Sugar, Baseline', 'timeFrame': 'baseline'}, {'measure': 'Intake of Red Meat, Baseline', 'timeFrame': 'baseline'}, {'measure': 'Intake of Poultry, Baseline', 'timeFrame': 'baseline'}, {'measure': 'Intake of Fish, Baseline', 'timeFrame': 'baseline'}, {'measure': 'HbA1C, Post-test', 'timeFrame': 'post-test, after completion of all six group sessions'}, {'measure': 'C-peptid, 0-h, Post-test', 'timeFrame': 'post-test, after completion of all six group sessions'}, {'measure': 'C-peptid, 2-h, Post-test', 'timeFrame': 'post-test, after completion of all six group sessions'}, {'measure': 'Insulin, 0-h, Post-test', 'timeFrame': 'post-test, after completion of all six group sessions'}, {'measure': 'Insulin, 2-h, Post-test', 'timeFrame': 'post-test, after completion of all six group sessions'}, {'measure': 'High-Density Lipoprotein Cholesterol, Post-test', 'timeFrame': 'post-test, after completion of all six group sessions'}, {'measure': 'Triglycerides, Post-test', 'timeFrame': 'post-test, after completion of all six group sessions'}, {'measure': 'Systolic Blood Pressure, Post-test', 'timeFrame': 'post-test, after completion of all six group sessions'}, {'measure': 'Diastolic Blood Pressure, Post-test', 'timeFrame': 'post-test, after completion of all six group sessions'}, {'measure': 'Waist Circumference', 'timeFrame': 'post-test, after completion of all six group sessions'}, {'measure': 'Body Mass Index, Post-test', 'timeFrame': 'post-test, after completion of all six group sessions'}, {'measure': 'Intake of Vegetables, Fruit and Fruit Juice, Post-test', 'timeFrame': 'post-test, after completion of all six group sessions'}, {'measure': 'Intake of Soft Drinks With Added Sugar, Post-test', 'timeFrame': 'post-test, after completion of all six group sessions'}, {'measure': 'Intake of Red Meat, Post-test', 'timeFrame': 'post-test, after completion of all six group sessions'}, {'measure': 'Intake of Poultry, Post-test', 'timeFrame': 'post-test, after completion of all six group sessions'}, {'measure': 'Intake of Fish, Post Test', 'timeFrame': 'post-test, after completion of all six group sessions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lifestyle intervention', 'Type 2 Diabetes', 'Metabolic syndrome', 'Pakistani women', 'dietary change', 'Physical activity', 'Norway'], 'conditions': ['Metabolic Syndrome', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Immigrants from South Asia in Norway have a high prevalence of type 2 diabetes and conditions related to the metabolic syndrome. It has been documented that these conditions may be prevented by changes in lifestyle. No previous intervention studies on immigrants with focus on diet and physical activity have been carried out in Norway. This project concerns a randomized controlled trial with intervention to change diet and physical activity in 200 high risk female Pakistani immigrants living in Oslo. The intervention will be evaluated both in terms of outcome and process.', 'detailedDescription': 'Objectives:\n\n1. 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.\n2. 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.\n\nBackground: 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.\n\nIntervention 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.\n\nThe 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).\n\nEvaluation: 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.\n\nSecondary 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.\n\nDietary 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.\n\nPhysical 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.\n\nThe completion of the questionnaires will take the form of an interview by Urdu speaking staff.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Risk score developed by Ramachandran et al for Asian Indians:\n\n * BMI, waist circumference, family history of diabetes and sedentary physical activity\n\nExclusion Criteria:\n\n* Type 1 diabetes.\n* Positive auto antibodies.\n* Diagnosis of type 2 diabetes more than 6 months.\n* Medication for type 2 diabetes.\n* Pregnancy at intervention start.\n* Suffering from heart attack or stroke the last 3 months.\n* Already participating in organised physical exercise.'}, 'identificationModule': {'nctId': 'NCT00425269', 'acronym': 'InnvaDiab', 'briefTitle': 'Lifestyle Intervention for Pakistani Women in Oslo', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'Evaluation of a Lifestyle Intervention to Prevent Type 2 Diabetes/Metabolic Syndrome Among Pakistani Immigrants - Focusing on Changes in Diet and Physical Activity', 'orgStudyIdInfo': {'id': 'NFR 166998/166977'}, 'secondaryIdInfos': [{'id': 'EU-DEPLAN 2004310'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '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', 'interventionNames': ['Behavioral: lifestyle intervention (diet and physical activity)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'One lesson recieved after post-test'}], 'interventions': [{'name': 'lifestyle intervention (diet and physical activity)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1255', 'city': 'Oslo', 'state': 'Holmlia, Oslo', 'country': 'Norway', 'facility': 'Primary Health Care Health Center', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Gerd Holmboe-Ottesen, Dr. Philos.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oslo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}, {'name': 'The Research Council of Norway', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Gerd Holmboe-Ottesen', 'investigatorAffiliation': 'University of Oslo'}}}}