Trial Outcomes & Findings for Diabetes Prevention and Control in the Workplace: A Pilot Study (NCT NCT00739336)

NCT ID: NCT00739336

Last Updated: 2016-10-05

Results Overview

Weight loss in kg

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2016-10-05

Participant Flow

Participant milestones

Measure	Intervention A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.	Control This is a "wait control" group, This group will begin the program (described in A,1) after 3 months.
Overall Study STARTED	21	24
Overall Study COMPLETED	17	24
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diabetes Prevention and Control in the Workplace: A Pilot Study

Baseline characteristics by cohort

Measure	Intervention n=21 Participants A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years. Diabetes Prevention and Control: The program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings.	Control n=24 Participants This is a "wait control" group, This group will begin the program (described in A,1) after 3 months.	Total n=45 Participants Total of all reporting groups
Age, Continuous	51.1 years STANDARD_DEVIATION 9.6 • n=5 Participants	51.2 years STANDARD_DEVIATION 6.4 • n=7 Participants	51.2 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	24 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Participants from the wait-list "Control" Arm have been combined in the "Intervention" Arm with those receiving the intervention immediately upon study entry for the purposes of this analysis.

Weight loss in kg

Outcome measures

Measure	Intervention n=41 Participants A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.	Control n=24 Participants This is a "wait control" group, This group will begin the program (described in A,1) after 3 months.
Body Weight	-2.3 kg Interval -3.5 to -0.97	0.73 kg Interval 0.17 to 1.28

SECONDARY outcome

Timeframe: Baseline

Fasting glucose (mg/dL)

Outcome measures

Measure	Intervention n=21 Participants A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.	Control n=24 Participants This is a "wait control" group, This group will begin the program (described in A,1) after 3 months.
Fasting Glucose Level	107 mg/dL Standard Deviation 36	111 mg/dL Standard Deviation 36

SECONDARY outcome

Timeframe: Baseline

LDL-cholesterol (mg/dL)

Outcome measures

Measure	Intervention n=21 Participants A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.	Control n=24 Participants This is a "wait control" group, This group will begin the program (described in A,1) after 3 months.
Fasting Lipid Profile	126 mg/dL Standard Deviation 24	112 mg/dL Standard Deviation 34

SECONDARY outcome

Timeframe: baseline

hemoglobin A1c (%)

Outcome measures

Measure	Intervention n=21 Participants A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.	Control n=24 Participants This is a "wait control" group, This group will begin the program (described in A,1) after 3 months.
Hemoglobin A1c	6.2 percent Standard Deviation 1.3	6.4 percent Standard Deviation 1.3

SECONDARY outcome

Timeframe: baseline, 3, 6, 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 3, 6, 12 months

Outcome measures

Outcome data not reported

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

Clinical Trials Officer

SUNY Upstate Medical University

Phone: 315-464-5476

Email: Rudesj@upstate.edu

Results disclosure agreements

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