Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480779
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2007-05-29
Brief Title:
Evaluation of Group Lifestyle Balance DVD in Primary Care Practice
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Screening Training Education and Prevention Service of the University of Pittsburgh Phase 2
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEPUP
Brief Summary:
The purpose of this study is to examine different methods of delivering the Group Lifestyle Balance GLB intervention 1 The GLB is a 12-week lifestyle change program based on the highly successful lifestyle program that was used in the Diabetes Prevention Program DPP2 A DVD of the Group Lifestyle Program has been developed Conditions called metabolic syndrome and pre-diabetes increase the risk of diabetes and heart disease Recent research has shown that type 2 diabetes and metabolic syndrome may be prevented or delayed by making lifestyle changes A primary care practice will enroll participants who will choose either the GLB-DVD intervention or face-to-face group delivery Approximately 25 patients will be recruited in each group It is not known if the GLB intervention delivered via DVD is similarly effective to face-to-face group delivery for people with metabolic syndrome or pre-diabetes It is hoped that this research study will provide information to help answer that question
Detailed Description:
The Group Lifestyle Balance program is a 12-session lifestyle intervention with the same goals for weight loss and physical activity as the successful Diabetes Prevention Program DPP lifestyle intervention and has been evaluated in several settings The DPSC collaborated with the US Air Force Center of Excellence for Medical Multimedia to create a DVD of the GLB The GLB-DVD is a series of taped sessions of a staged group following a script that was developed to closely follow the program
Effectiveness was assessed for the intervention delivered via DVD GLB-DVD as well as traditionally in a group setting GLB-GROUP For each delivery mode pre- and 3 month post-intervention measures of weight and the achievement of the program goals were assessed Secondary outcomes measured included assessment of components of the metabolic syndrome NCEP ATP III and HbA1c
The prevention professionals in the practice and the Diabetes Prevention Support Center DPSC who provided support for the GLB-DVD and GLB-GROUP participants were health care professionals trained in delivery of the GLB by the DPSC faculty Group delivery of the GLB was conducted via weekly in person meetings delivered over 12-15 weeks For GLB-DVD delivery an overview of the GLB-DVD and materials was provided at commencement of the intervention Participants were instructed to view one sessionweek At the end of each month the participant was asked to return their DVD via postage-paid mail to the DPSC and the next sequential DVD was mailed to the participant During GLB-DVD delivery the DPSC prevention professional contacted the participant weekly via telephone to review weight physical activity minutes and questionsconcerns regarding the program Thus participants in both GLB-GROUP and GLB-DVD were offered a total of 12 health care professional contacts 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
Effectiveness was assessed for the intervention delivered via DVD GLB-DVD as well as traditionally in a group setting GLB-GROUP For each delivery mode pre- and 3 month post-intervention measures of weight and the achievement of the program goals were assessed Secondary outcomes measured included assessment of components of the metabolic syndrome NCEP ATP III and HbA1c
The prevention professionals in the practice and the Diabetes Prevention Support Center DPSC who provided support for the GLB-DVD and GLB-GROUP participants were health care professionals trained in delivery of the GLB by the DPSC faculty Group delivery of the GLB was conducted via weekly in person meetings delivered over 12-15 weeks For GLB-DVD delivery an overview of the GLB-DVD and materials was provided at commencement of the intervention Participants were instructed to view one sessionweek At the end of each month the participant was asked to return their DVD via postage-paid mail to the DPSC and the next sequential DVD was mailed to the participant During GLB-DVD delivery the DPSC prevention professional contacted the participant weekly via telephone to review weight physical activity minutes and questionsconcerns regarding the program Thus participants in both GLB-GROUP and GLB-DVD were offered a total of 12 health care professional contacts 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None