Trial Outcomes & Findings for Lifestyle Intervention for Pakistani Women in Oslo (NCT NCT00425269)

NCT ID: NCT00425269

Last Updated: 2014-07-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 198 participants
• Primary outcome timeframe: baseline
• Results posted on: 2014-07-21

Participant Flow

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

Participant milestones

Measure	Intervention 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. The 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.	Control Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests.
Overall Study STARTED	101	97
Overall Study COMPLETED	82	77
Overall Study NOT COMPLETED	19	20

Reasons for withdrawal

Measure	Intervention 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. The 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.	Control Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests.
Overall Study Pregnancy	5	7
Overall Study Lost to Follow-up	9	9
Overall Study moved or medical reason	5	4

Baseline Characteristics

Lifestyle Intervention for Pakistani Women in Oslo

Baseline characteristics by cohort

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests.	Total n=198 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	101 Participants n=5 Participants	97 Participants n=7 Participants	198 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	97 Participants n=7 Participants	198 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Norway	101 participants n=5 Participants	97 participants n=7 Participants	198 participants n=5 Participants
Years of residence in Norway	18 years STANDARD_DEVIATION 7.9 • n=5 Participants	19 years STANDARD_DEVIATION 7.6 • n=7 Participants	19 years STANDARD_DEVIATION 7.8 • n=5 Participants
Years of education	9 years STANDARD_DEVIATION 4.7 • n=5 Participants	9 years STANDARD_DEVIATION 4.3 • n=7 Participants	9 years STANDARD_DEVIATION 4.5 • n=5 Participants
Body Mass Index	29.4 kg/m^2 STANDARD_DEVIATION 5.6 • n=5 Participants	29.8 kg/m^2 STANDARD_DEVIATION 5.5 • n=7 Participants	29.6 kg/m^2 STANDARD_DEVIATION 5.6 • n=5 Participants

PRIMARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
The Fasting Plasma Glucose Value, Baseline	5.55 mmol/L Interval 5.37 to 5.72	5.53 mmol/L Interval 5.37 to 5.69

PRIMARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline	8.52 mmol/L Interval 8.03 to 9.02	8.41 mmol/L Interval 7.86 to 8.96

PRIMARY outcome

Timeframe: post-test

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
The Fasting Plasma Glucose, Post-test	5.39 mmol/L Interval 5.24 to 5.54	5.66 mmol/L Interval 5.36 to 5.95

PRIMARY outcome

Timeframe: post-test

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Plasma Glucose, 2-h, Post-test	8.00 mmol/L Interval 7.52 to 8.48	8.20 mmol/L Interval 7.58 to 8.8

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
HbA1c, Baseline	5.4 percent of Hb Interval 5.3 to 5.5	5.4 percent of Hb Interval 5.3 to 5.5

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
C-peptide, 0-h, Baseline	855.0 pmol/L Interval 787.2 to 922.8	839.9 pmol/L Interval 769.3 to 910.5

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
C-peptid, 2-h, Baseline	3851.5 pmol/L Interval 3508.1 to 4194.9	3628.9 pmol/L Interval 3258.2 to 3999.5

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Insulin, 0-h, Baseline	127.6 pmol/L Interval 113.6 to 141.7	116.3 pmol/L Interval 103.9 to 128.6

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Insulin, 2-h, Baseline	931.1 pmol/L Interval 715.2 to 1146.7	839.5 pmol/L Interval 593.6 to 1085.4

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
High-Density Lipoprotein Cholesterol, Baseline	1.26 mmol/L Interval 1.2 to 1.33	1.25 mmol/L Interval 1.19 to 1.32

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Triglycerides, Baseline	1.4 mmol/L Interval 1.2 to 1.5	1.4 mmol/L Interval 1.3 to 1.5

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Systolic Blood Pressure, Baseline	115.6 mmHg Interval 111.7 to 119.6	118.7 mmHg Interval 115.5 to 122.0

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Diastolic Blood Pressure, Baseline	80.0 mmHg Interval 77.8 to 82.4	80.8 mmHg Interval 78.9 to 82.7

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Waist Circumference, Baseline	95.3 cm Interval 92.4 to 98.1	96.2 cm Interval 93.9 to 98.5

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Body Mass Index, Baseline	29.39 kg/m^2 Interval 28.3 to 30.6	29.73 kg/m^2 Interval 28.6 to 30.9

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Intake of Vegetables, Fruit and Fruit Juice, Baseline	328.9 gram per day Interval 161.0 to 450.0	306.3 gram per day Interval 193.0 to 375.0

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Intake of Soft Drinks With Added Sugar, Baseline	5.0 dL/week Interval 0.0 to 5.8	4.4 dL/week Interval 0.0 to 5.8

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Intake of Red Meat, Baseline	2.1 portions/week Interval 1.0 to 2.5	2.0 portions/week Interval 1.0 to 2.5

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Intake of Poultry, Baseline	2.1 portions/week Interval 1.0 to 3.0	2.1 portions/week Interval 1.0 to 2.5

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Intervention n=101 Participants 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. The 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.	Control n=97 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Intake of Fish, Baseline	0.97 portions/week Interval 0.38 to 1.3	0.77 portions/week Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
HbA1C, Post-test	5.4 percent of Hb Interval 5.3 to 5.5	5.5 percent of Hb Interval 5.3 to 5.6

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
C-peptid, 0-h, Post-test	878.5 pmol/L Interval 809.0 to 948.1	914.6 pmol/L Interval 837.8 to 991.5

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
C-peptid, 2-h, Post-test	3618.1 pmol/L Interval 3297.8 to 3938.3	3439.9 pmol/L Interval 3096.4 to 3783.4

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Insulin, 0-h, Post-test	121.8 pmol/L Interval 110.6 to 133.1	123.3 pmol/L Interval 112.1 to 134.5

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Insulin, 2-h, Post-test	861.8 pmol/L Interval 660.8 to 1062.8	786.1 pmol/L Interval 615.2 to 957.1

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
High-Density Lipoprotein Cholesterol, Post-test	1.24 mmol/L Interval 1.17 to 1.3	1.20 mmol/L Interval 1.14 to 1.26

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Triglycerides, Post-test	1.3 mmol/L Interval 1.2 to 1.5	1.5 mmol/L Interval 1.3 to 1.6

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Systolic Blood Pressure, Post-test	114.4 mmHg Interval 111.0 to 117.7	117.1 mmHg Interval 114.0 to 120.2

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Diastolic Blood Pressure, Post-test	78.6 mmHg Interval 76.4 to 80.8	80.1 mmHg Interval 77.9 to 82.2

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Waist Circumference	95.1 cm Interval 92.4 to 97.9	96.8 cm Interval 94.5 to 99.1

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Body Mass Index, Post-test	29.11 kg/m^2 Interval 28.0 to 30.3	29.65 kg/m^2 Interval 28.5 to 30.8

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Intake of Vegetables, Fruit and Fruit Juice, Post-test	375.4 grams per day Interval 193.0 to 493.0	328.3 grams per day Interval 193.0 to 450.0

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Intake of Soft Drinks With Added Sugar, Post-test	2.5 dl/week Interval 0.0 to 5.8	5.1 dl/week Interval 0.0 to 5.8

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Intake of Red Meat, Post-test	1.6 portions/week Interval 1.0 to 2.0	2.0 portions/week Interval 1.0 to 2.5

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Intake of Poultry, Post-test	1.9 portions/week Interval 1.0 to 2.5	1.8 portions/week Interval 1.0 to 2.5

SECONDARY outcome

Timeframe: post-test, after completion of all six group sessions

Outcome measures

Measure	Intervention n=82 Participants 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. The 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.	Control n=77 Participants Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
Intake of Fish, Post Test	1.13 portions/week Interval 0.5 to 1.5	1.11 portions/week Interval 0.0 to 2.0

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Victoria Telle Hjellset

University of Oslo

Phone: 0047 22 85 06 12

Email: t.v.t.hjellset@medisin.uio.no

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place