University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT00480779
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 (DPP)(2). 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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15213, United States
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 session/week. 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 questions/concerns 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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 weekly telephone contact with a trained lifestyle coach.
Time frame: Baseline and 3 months
The primary outcome for this study will be change in weight measured pre and post intervention.
Time frame: Baseline and 3 months
A secondary outcome for this study will be change in waist circumference, measured pre and post intervention.
Time frame: Baseline and 3 months
A secondary outcome for this study will be change in total cholesterol, measured pre and post intervention.
Time frame: Baseline and 3 months
A secondary outcome for this study will be change in HDL cholesterol, measured pre and post intervention.
Time frame: Baseline and 3 months
A secondary outcome for this study will be change in LDL cholesterol, measured pre and post intervention.
Time frame: Baseline and 3 months
A secondary outcome for this study will be change in fasting glucose, measured pre and post intervention.
Time frame: Baseline and 3 months
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..
Time frame: Baseline and 3 months
A secondary outcome for this study will be change in systolic blood pressure, measured pre and post intervention.
Time frame: Baseline and 3 months
A secondary outcome for this study will be change in diastolic blood pressure, measured pre and post intervention.
Time frame: Baseline and 3 months
A secondary outcome for this study will be change in Triglyceride level, measured pre and post intervention.
University of Pittsburgh
Other
Screening, Training, Education and Prevention Service of the University of Pittsburgh, Phase 2
Acronym: STEPUP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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