Trial Outcomes & Findings for Evaluation of a Primary Type 2 Diabetes Prevention Programme (NCT NCT00707447)

Results Overview

Mean weight change (in kg) after 12 months

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

182 participants

Primary outcome timeframe

12 month

Results posted on

2014-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	1/Control Control group received written instruction about healthy eating and increasing physical exercise	2/PREDIAS Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle
Overall Study STARTED	89	93
Overall Study COMPLETED	81	85
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Primary Type 2 Diabetes Prevention Programme

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1/Control n=89 Participants Control group received written instruction about healthy eating and increasing physical exercise	2/PREDIAS n=93 Participants Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle	Total n=182 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	72 Participants n=99 Participants	80 Participants n=107 Participants	152 Participants n=206 Participants
Age, Categorical >=65 years	17 Participants n=99 Participants	13 Participants n=107 Participants	30 Participants n=206 Participants
Age, Continuous	55.9 years STANDARD_DEVIATION 10.7 • n=99 Participants	56.6 years STANDARD_DEVIATION 9.6 • n=107 Participants	56.2 years STANDARD_DEVIATION 10.1 • n=206 Participants
Sex: Female, Male Female	40 Participants n=99 Participants	38 Participants n=107 Participants	78 Participants n=206 Participants
Sex: Female, Male Male	49 Participants n=99 Participants	55 Participants n=107 Participants	104 Participants n=206 Participants
Region of Enrollment Germany	89 participants n=99 Participants	93 participants n=107 Participants	182 participants n=206 Participants

PRIMARY outcome

Timeframe: 12 month

Population: Intention to treat analysis (LOCF) and per protocol analysis for primary outcome and per protocol analysis for secondary outcome measures

Mean weight change (in kg) after 12 months

Outcome measures

Outcome measures
Measure	Lifestyle Intervention Group (PREDIAS) n=85 Participants 10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes	Control Group n=81 Participants Written information material about diabetes prevention by loosing weight, increasing physical activity
Weight Change	-3.8 kg Standard Deviation 5.2	-1.4 kg Standard Deviation 4.0

PRIMARY outcome

Timeframe: 12 months

Mean change in waist circumference (in cm) after 12 months

Outcome measures

Outcome measures
Measure	Lifestyle Intervention Group (PREDIAS) n=85 Participants 10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes	Control Group n=81 Participants Written information material about diabetes prevention by loosing weight, increasing physical activity
Waist Circumference	-4.1 cm Standard Deviation 6.0	-0.4 cm Standard Deviation 6.2

SECONDARY outcome

Timeframe: 12 months

Mean changes in fasting glucose (in mg/dl) after 12 month

Outcome measures

Outcome measures
Measure	Lifestyle Intervention Group (PREDIAS) n=85 Participants 10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes	Control Group n=81 Participants Written information material about diabetes prevention by loosing weight, increasing physical activity
Fasting Glucose	-4.3 mg/dl Standard Deviation 11.3	1.8 mg/dl Standard Deviation 13.1

SECONDARY outcome

Timeframe: 12 months

Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months

Outcome measures

Outcome measures
Measure	Lifestyle Intervention Group (PREDIAS) n=85 Participants 10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes	Control Group n=81 Participants Written information material about diabetes prevention by loosing weight, increasing physical activity
Glucose Tolerance	-7.3 mg/dl Standard Deviation 30.8	-8.2 mg/dl Standard Deviation 36.9

SECONDARY outcome

Timeframe: 12 months

Mean changes in physical exercise (in min/week) after 12 months

Outcome measures

Outcome measures
Measure	Lifestyle Intervention Group (PREDIAS) n=85 Participants 10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes	Control Group n=81 Participants Written information material about diabetes prevention by loosing weight, increasing physical activity
Physical Exercise	46.6 minutes per week Standard Deviation 95.5	17.9 minutes per week Standard Deviation 63.8

SECONDARY outcome

Timeframe: 12 months

The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale "cognitive restraint" consists of 21 Item with a minimum score of "0" and a maximum score of "21". Low scores indicate an uninhibited eating behavior. Mean change in the TFEQ - cognitive restraint scale after 12 months

Outcome measures

Outcome measures
Measure	Lifestyle Intervention Group (PREDIAS) n=85 Participants 10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes	Control Group n=81 Participants Written information material about diabetes prevention by loosing weight, increasing physical activity
Eating Behavior (TFEQ) - Cognitive Restraint	3.9 units on a scale Standard Deviation 3.8	1.5 units on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: 12 months

The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale "disinhibition" consists of 16 Item with a minimum score of "0" and a maximum score of "16". High scores indicate an uninhibited eating behavior strongly depending on external cues. Mean change in the TFEQ - disinhibition scale after 12 months

Outcome measures

Outcome measures
Measure	Lifestyle Intervention Group (PREDIAS) n=85 Participants 10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes	Control Group n=81 Participants Written information material about diabetes prevention by loosing weight, increasing physical activity
Eating Behavior (TFEQ) - Disinhibition	-1.2 units on a scale Standard Deviation 2.7	-0.4 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 12 months

The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale "hunger" consists of 14 Item with a minimum score of "0" and a maximum score of "14". Low scores indicate an eating behavior strongly depending on feelings of hunger. Mean change in the TFEQ - hunger scale after 12 months

Outcome measures

Outcome measures
Measure	Lifestyle Intervention Group (PREDIAS) n=85 Participants 10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes	Control Group n=81 Participants Written information material about diabetes prevention by loosing weight, increasing physical activity
Eating Behavior (TFEQ) - Hunger	-1.1 units on a scale Standard Deviation 3.1	-0.2 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 12 months

The WHO (Five) Well-being index consists of 5 items on the overall well-being over the last two weeks. Each of the five items is rated from 0 (= not present) to 5 (= constantly present). Scores are summated, with raw score ranging from 0 to 25. Then the scores are transformed to 0-100 by multiplying by 4, with higher scores meaning better well-being. Mean change in psychological well-being score (WHO-5) after 12 months

Outcome measures

Outcome measures
Measure	Lifestyle Intervention Group (PREDIAS) n=85 Participants 10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes	Control Group n=81 Participants Written information material about diabetes prevention by loosing weight, increasing physical activity
Psychological Well-being (WHO-5)	1.4 units on a scale Standard Deviation 3.9	0.0 units on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: 12 months

The Center for Epidemiologic Studies Depression Scale (CES-D) consists of 20 items scored from "0" to "3". Scores are summated, with raw score ranging from 0 to 25. Higher Scores idicate a higher depressive state. Mean change in depression score (CES-D) after 12 months

Outcome measures

Outcome measures
Measure	Lifestyle Intervention Group (PREDIAS) n=85 Participants 10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes	Control Group n=81 Participants Written information material about diabetes prevention by loosing weight, increasing physical activity
Emotional Well-being/ Depression (CES-D)	-3.5 units on a scale Standard Deviation 7.1	-1.0 units on a scale Standard Deviation 6.1

Adverse Events

1/Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2/PREDIAS

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

Norbert Hermanns

FIDAM

Phone: 0049 7931 594

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place