Trial Outcomes & Findings for Evaluation of Group Lifestyle Balance DVD in Primary Care Practice (NCT NCT00480779)
NCT ID: NCT00480779
Last Updated: 2016-06-28
Results Overview
The primary outcome for this study will be change in weight measured pre and post intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2016-06-28
Participant Flow
Patients meeting the criteria for participation were referred by their health care provider, who also provided approval for moderate intensity physical activity. After completing informed consent, participants chose which mode of delivery they preferred, GLB-DVD or GLB-GROUP.
Participant milestones
| Measure |
GLB Group
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
|
GLB DVD
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
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|---|---|---|
|
Overall Study
STARTED
|
26
|
22
|
|
Overall Study
COMPLETED
|
24
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
GLB Group
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
|
GLB DVD
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
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|---|---|---|
|
Overall Study
Other
|
2
|
0
|
|
Overall Study
Job and Health-related
|
0
|
3
|
Baseline Characteristics
Evaluation of Group Lifestyle Balance DVD in Primary Care Practice
Baseline characteristics by cohort
| Measure |
GLB Group
n=26 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
|
GLB DVD
n=22 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 11.9 • n=99 Participants
|
57.3 years
STANDARD_DEVIATION 13.6 • n=107 Participants
|
59.1 years
STANDARD_DEVIATION 12.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants
|
22 participants
n=107 Participants
|
48 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Intent to treat using Last Observation Carried Forward (LOCF)
The primary outcome for this study will be change in weight measured pre and post intervention.
Outcome measures
| Measure |
GLB Group
n=26 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach.
|
GLB DVD
n=22 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and
|
|---|---|---|
|
Change in Weight
|
-13.9 pounds
Standard Deviation 14.3
|
-11.8 pounds
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Intent to treat
A secondary outcome for this study will be change in waist circumference, measured pre and post intervention.
Outcome measures
| Measure |
GLB Group
n=26 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach.
|
GLB DVD
n=22 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and
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|---|---|---|
|
Change in Waist Circumference
|
-2.49 inches
Standard Deviation 2.08
|
-1.87 inches
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.
A secondary outcome for this study will be change in total cholesterol, measured pre and post intervention.
Outcome measures
| Measure |
GLB Group
n=24 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach.
|
GLB DVD
n=18 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and
|
|---|---|---|
|
Change in Total Cholesterol
|
-8.29 mg/dl
Standard Deviation 27.09
|
-9.94 mg/dl
Standard Deviation 19.08
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.
A secondary outcome for this study will be change in HDL cholesterol, measured pre and post intervention.
Outcome measures
| Measure |
GLB Group
n=24 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach.
|
GLB DVD
n=18 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and
|
|---|---|---|
|
Change in HDL Cholesterol
|
-2.08 mg/dl
Standard Deviation 5.9
|
-0.72 mg/dl
Standard Deviation 3.71
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.
A secondary outcome for this study will be change in LDL cholesterol, measured pre and post intervention.
Outcome measures
| Measure |
GLB Group
n=24 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach.
|
GLB DVD
n=18 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and
|
|---|---|---|
|
Change in LDL Cholesterol
|
0.33 mg/dl
Standard Deviation 20.87
|
-2.67 mg/dl
Standard Deviation 14.69
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.
A secondary outcome for this study will be change in fasting glucose, measured pre and post intervention.
Outcome measures
| Measure |
GLB Group
n=26 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach.
|
GLB DVD
n=21 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and
|
|---|---|---|
|
Change in Fasting Glucose
|
1.15 mg/dl
Standard Deviation 10.52
|
-4.71 mg/dl
Standard Deviation 6.66
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.
A secondary outcome for this study will be change in HbA1c, measured pre and post intervention. The hemoglobin HbA1c test provides information regarding how well blood glucose (sugar) has been controlled for the previous 8-12 weeks..
Outcome measures
| Measure |
GLB Group
n=26 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach.
|
GLB DVD
n=21 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and
|
|---|---|---|
|
Change in Hemoglobin A1C
|
-0.31 percentage of glycosylated hemoglobin
Standard Deviation 0.25
|
-0.16 percentage of glycosylated hemoglobin
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.
A secondary outcome for this study will be change in systolic blood pressure, measured pre and post intervention.
Outcome measures
| Measure |
GLB Group
n=20 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach.
|
GLB DVD
n=21 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
-6.55 mmHg
Standard Deviation 11.29
|
-4.95 mmHg
Standard Deviation 6.68
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.
A secondary outcome for this study will be change in diastolic blood pressure, measured pre and post intervention.
Outcome measures
| Measure |
GLB Group
n=20 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach.
|
GLB DVD
n=21 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and
|
|---|---|---|
|
Change in Diastolic Blood Pressure
|
-3.6 mmHg
Standard Deviation 7.68
|
-1.43 mmHg
Standard Deviation 6.88
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.
A secondary outcome for this study will be change in Triglyceride level, measured pre and post intervention.
Outcome measures
| Measure |
GLB Group
n=26 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach.
|
GLB DVD
n=22 Participants
The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and
|
|---|---|---|
|
Change in Triglycerides
|
-2.0 mg/dl
Interval -43.0 to 1.0
|
0 mg/dl
Interval -26.0 to 0.0
|
Adverse Events
GLB Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GLB DVD
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place