Trial Outcomes & Findings for Diabetes Prevention Translation: the Healthy Lifestyle Project (NCT NCT01050205)
NCT ID: NCT01050205
Last Updated: 2017-08-25
Results Overview
Weight was measured twice using a digital physician's scale (DETECTO® PD100) placed on a hard, flat surface. Participants were asked to remove their shoes and stand in the middle of the scale with eyes straight forward and without touching any surface. The participant was asked to step down from the scale between measures. If the measures were more than 0.5 pounds apart, a third measure was taken. Weight is reported in pounds.
COMPLETED
NA
223 participants
Baseline and post-intervention (assessed at 6 months after commencement of intervention)
2017-08-25
Participant Flow
Individuals were recruited via screenings in 3 community settings: a) a local work site, b) 3 community/senior centers, and c) a military medical facility. The military medical facility was a pre-post study not an RCT. Results are presented for the RCT sites. Recruitment at these sites began in Fall of 2010 and was completed in Winter of 2013.
Participant milestones
| Measure |
Current Intervention
At enrollment, participants randomly assigned to "Current Intervention" will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Delayed Intervention
At enrollment, participants randomly assigned to "Delayed intervention" will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
75
|
|
Overall Study
COMPLETED
|
137
|
71
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
Reasons for withdrawal
| Measure |
Current Intervention
At enrollment, participants randomly assigned to "Current Intervention" will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Delayed Intervention
At enrollment, participants randomly assigned to "Delayed intervention" will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
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|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Relocated from area
|
1
|
2
|
|
Overall Study
Discontinued Intervention
|
2
|
0
|
Baseline Characteristics
Diabetes Prevention Translation: the Healthy Lifestyle Project
Baseline characteristics by cohort
| Measure |
Current Intervention
n=148 Participants
At enrollment, participants are randomly assigned to "Current Intervention" will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Delayed Intervention
n=75 Participants
At enrollment, participants are randomly assigned to "Delayed intervention" will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Total
n=223 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 11.4 • n=93 Participants
|
57.2 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
58.4 years
STANDARD_DEVIATION 11.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
148 participants
n=93 Participants
|
75 participants
n=4 Participants
|
223 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and post-intervention (assessed at 6 months after commencement of intervention)Population: Intent to treat using last observation carried forward when data are missing.
Weight was measured twice using a digital physician's scale (DETECTO® PD100) placed on a hard, flat surface. Participants were asked to remove their shoes and stand in the middle of the scale with eyes straight forward and without touching any surface. The participant was asked to step down from the scale between measures. If the measures were more than 0.5 pounds apart, a third measure was taken. Weight is reported in pounds.
Outcome measures
| Measure |
Current Intervention
n=148 Participants
At enrollment, participants randomly assigned to "Current Intervention" will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Delayed Intervention
n=75 Participants
At enrollment, participants randomly assigned to "Delayed intervention" will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
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|---|---|---|
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Changes in Weight Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
|
-10.4 Pounds
Standard Deviation 10.1
|
-1.8 Pounds
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Baseline and post-intervention (assessed at 6 months after commencement of intervention)Population: Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.
After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.
Outcome measures
| Measure |
Current Intervention
n=148 Participants
At enrollment, participants randomly assigned to "Current Intervention" will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Delayed Intervention
n=72 Participants
At enrollment, participants randomly assigned to "Delayed intervention" will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
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|---|---|---|
|
Changes in Fasting Glucose Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
|
-1.9 mg/dl
Standard Deviation 8.0
|
-1.5 mg/dl
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: Baseline and post-intervention (assessed at 6 months after commencement of intervention)Population: Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.
Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.
Outcome measures
| Measure |
Current Intervention
n=147 Participants
At enrollment, participants randomly assigned to "Current Intervention" will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Delayed Intervention
n=71 Participants
At enrollment, participants randomly assigned to "Delayed intervention" will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
|---|---|---|
|
Changes in Fasting Insulin Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
|
-0.18 mg/dl
Standard Deviation 5.1
|
0.81 mg/dl
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline and post-intervention (assessed at 6 months after commencement of intervention)Population: Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.
Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the work site and community/senior centers.
Outcome measures
| Measure |
Current Intervention
n=133 Participants
At enrollment, participants randomly assigned to "Current Intervention" will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Delayed Intervention
n=67 Participants
At enrollment, participants randomly assigned to "Delayed intervention" will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
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|---|---|---|
|
Changes in Fasting Lipids (Total Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
|
-2.5 mg/dl
Standard Deviation 22.4
|
-0.5 mg/dl
Standard Deviation 20.9
|
SECONDARY outcome
Timeframe: Baseline and post-intervention (assessed at 6 months after commencement of intervention)Population: Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.
Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.
Outcome measures
| Measure |
Current Intervention
n=133 Participants
At enrollment, participants randomly assigned to "Current Intervention" will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Delayed Intervention
n=66 Participants
At enrollment, participants randomly assigned to "Delayed intervention" will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
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|---|---|---|
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Changes in Fasting Lipids (Triglycerides) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
|
-1.0 mg/dl
Interval -28.0 to 19.0
|
6.5 mg/dl
Interval -25.0 to 33.0
|
SECONDARY outcome
Timeframe: Baseline and post-intervention (assessed at 6 months after commencement of intervention)Population: Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.
Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.
Outcome measures
| Measure |
Current Intervention
n=133 Participants
At enrollment, participants randomly assigned to "Current Intervention" will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Delayed Intervention
n=67 Participants
At enrollment, participants randomly assigned to "Delayed intervention" will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
|---|---|---|
|
Changes in Fasting Lipids (HDL Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
|
0.3 mg/dl
Standard Deviation 7.6
|
-0.6 mg/dl
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Baseline and post-intervention (assessed at 6 months after commencement of intervention)Population: Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.
Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.
Outcome measures
| Measure |
Current Intervention
n=130 Participants
At enrollment, participants randomly assigned to "Current Intervention" will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Delayed Intervention
n=64 Participants
At enrollment, participants randomly assigned to "Delayed intervention" will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
|---|---|---|
|
Changes in Fasting Lipids (LDL Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
|
-1.3 mg/dl
Standard Deviation 19.1
|
-1.8 mg/dl
Standard Deviation 20.0
|
SECONDARY outcome
Timeframe: Baseline and post-intervention (assessed at 6 months after commencement of intervention)Population: Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.
Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers. A1c is a measure of glucose control over approximately an 8 to 12 week period.
Outcome measures
| Measure |
Current Intervention
n=148 Participants
At enrollment, participants randomly assigned to "Current Intervention" will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Delayed Intervention
n=72 Participants
At enrollment, participants randomly assigned to "Delayed intervention" will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
|---|---|---|
|
Changes in A1c Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
|
-0.11 percentage of glycosylated hemoglobin
Standard Deviation 0.16
|
-0.01 percentage of glycosylated hemoglobin
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Baseline and post-intervention (assessed at 6 months after commencement of intervention)Population: Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.
Blood pressure was measured in the right arm with the participant seated comfortably with the right arm resting on a table. All participants were asked to rest quietly with feet flat on the floor for five minutes. Following the five minute wait, the radial pulse was measured in the right arm and pulse obliteration level was assessed. The cuff was inflated to the peak inflation rate and the pressure released at a rate of 2mm/Hg per second. First appearance and last heard (phase V) Korotkoff's sounds were utilized to determine systolic and diastolic blood pressure respectively. The cuffed arm was then raised for 5 seconds after each inflation with a wait period of 30 seconds between each blood pressure reading. Blood pressure was repeated twice with the average computed. If it was not possible to measure blood pressure in the right arm, the left arm was utilized and noted in the participant record.
Outcome measures
| Measure |
Current Intervention
n=138 Participants
At enrollment, participants randomly assigned to "Current Intervention" will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Delayed Intervention
n=71 Participants
At enrollment, participants randomly assigned to "Delayed intervention" will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
|---|---|---|
|
Changes in Systolic Blood Pressure (BP) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
|
-2.5 mmHg
Standard Deviation 11.2
|
0.6 mmHg
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline and post-intervention (assessed at 6 months after commencement of intervention)Population: Intent to treat using last observation carried forward when data are missing.
The participant was asked stand with feet together. The waist was measured using a cloth measuring tape around the abdomen. The midpoints were marked horizontally at midpoint between highest point of the iliac crest and lowest part of the costal margin in the mid-axillary line. Both sides of the waist were marked using a cosmetic pencil. The participant was asked to have arms at side and to breathe in, out and hold, and then the measurement was taken. Waist measurement was recorded to the nearest quarter inch. The measure was repeated twice. If waist measures differ by more than one-half inch, a third measurement was recorded.
Outcome measures
| Measure |
Current Intervention
n=148 Participants
At enrollment, participants randomly assigned to "Current Intervention" will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Delayed Intervention
n=75 Participants
At enrollment, participants randomly assigned to "Delayed intervention" will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
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|---|---|---|
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Changes in Waist Circumference Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
|
-1.5 inches
Standard Deviation 2.0
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-0.05 inches
Standard Deviation 1.8
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SECONDARY outcome
Timeframe: Baseline and post-intervention (assessed at 6 months after commencement of intervention)Population: Intent to treat using last observation carried forward when data are missing.
The Modifiable Activity Questionnaire (MAQ) was designed by Dr. Kriska. It has been used to assess activity in a variety of populations and age groups over various time frames and was used to assess physical activity levels in the DPP. The MAQ includes both a leisure and an occupational activity section since the homogeneity of energy expenditure related to both of these components of activity within many study populations cannot be assumed. In addition, the MAQ was designed to be modified, based upon pilot testing, prior to its usage, in order to maximize the feasibility and appropriateness of the physical activity instrument to the population of interest. The MAQ has been shown to be both reliable and valid (through comparisons with activity monitors, fitness (field) testing, and the doubly labeled water technique) in adults and adolescents alike. The MAQ has been used to assess a variety of time frames from past year and past week to a lifetime of activity.
Outcome measures
| Measure |
Current Intervention
n=148 Participants
At enrollment, participants randomly assigned to "Current Intervention" will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Delayed Intervention
n=75 Participants
At enrollment, participants randomly assigned to "Delayed intervention" will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
|---|---|---|
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Changes in Self-reported Physical Activity Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
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13 MET-hrs leisure activity
Interval 2.6 to 28.2
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6.6 MET-hrs leisure activity
Interval -0.7 to 17.4
|
SECONDARY outcome
Timeframe: Baseline and post-intervention (assessed at 6 months after commencement of intervention)Population: Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.
Blood pressure was measured in the right arm with the participant seated comfortably with the right arm resting on a table. All participants were asked to rest quietly with feet flat on the floor for five minutes. Following the five minute wait, the radial pulse was measured in the right arm and pulse obliteration level was assessed. The cuff was inflated to the peak inflation rate and the pressure released at a rate of 2mm/Hg per second. First appearance and last heard (phase V) Korotkoff's sounds were utilized to determine systolic and diastolic blood pressure respectively. The cuffed arm was then raised for 5 seconds after each inflation with a wait period of 30 seconds between each blood pressure reading. Blood pressure was repeated twice with the average computed. If it was not possible to measure blood pressure in the right arm, the left arm was utilized and noted in the participant record.
Outcome measures
| Measure |
Current Intervention
n=138 Participants
At enrollment, participants randomly assigned to "Current Intervention" will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
Delayed Intervention
n=71 Participants
At enrollment, participants randomly assigned to "Delayed intervention" will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:
GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach.
|
|---|---|---|
|
Changes in Diastolic Blood Pressure (BP) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.
|
-1.3 mmHg
Standard Deviation 8.8
|
-1.0 mmHg
Standard Deviation 7.9
|
Adverse Events
Current Intervention
Delayed Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place