PrediabetesSTEPUPNCT00480779

Evaluation of Group Lifestyle Balance DVD in Primary Care Practice

A study testing GLB Group and GLB DVD in people with Prediabetes and Metabolic Syndrome, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Prediabetes, Metabolic Syndrome
What is being tested?: GLB Group and GLB DVD
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited States
Study dates: Jun 2007to May 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All non-diabetic patients age 18 years and older at the time of enrollment considered to be patients of the practices that are taking part in this project will be eligible for the study upon referral from their physician.
Non-diabetic patients with metabolic syndrome AND/OR pre-diabetes are eligible for the study with referral from their physician based on the following criteria:
Metabolic Syndrome: Patients with BMI greater than or equal to 25 kg/m2, with at least 3 of the following risk factors for metabolic syndrome:
Waist circumference (>40 inches men, >35 inches women)
Blood pressure greater than or equal to 130 mmHg (systolic) and/or 85 mmHg (diastolic) OR history of diagnosed hypertension
Low HDL level (<40mg/dL men, <50 mg/dL women)

Show all 10Show fewer

Elevated triglyceride level greater than or equal to 150 mg/dL
Fasting glucose greater than or equal to 100mg/dL and <126mg/dL
Pre-diabetes: Patients with a BMI greater than or equal to 25 kg/m2 and pre-diabetes (fasting glucose greater than or equal to 100 mg/dL and <126mg/dL)
All measures should have been taken within six months of enrollment into the study. The physician in each center will be asked to refer eligible patients to the study. It will be the responsibility of the referring physician to determine eligibility and appropriateness of the patient's participation.

Who cannot join

Those patients age less than 18 years old will not be invited to be part of the study. In addition, patients with any of the following conditions are not eligible to take part in the study:
Those with previous diabetes diagnosis
Women who are currently (or within past 6-weeks) pregnant or lactating
Any patient deemed by their physician not to be a candidate
Any patient planning to leave the area before the end of the program
Individuals that are not patients of the participating primary care practices

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Screening, Training, Education and Prevention Service of the University of Pittsburgh, Phase 2

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.

Read the 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 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.

Conditions: Prediabetes, Metabolic Syndrome
Being tested: GLB Group, GLB DVD
Keywords: Prediabetes, Metabolic syndrome, Prevention, Lifestyle intervention
Medical subject headings: Prediabetic State, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GLB GroupBehavioural
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 DVDBehavioural
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.

Study groups in NCT00480779
Study group	Role	What they receive
GLB Group	Other	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. Receives: Behavioral: GLB Group
GLB DVD	Other	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. Receives: Behavioral: GLB DVD

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Weight
The primary outcome for this study will be change in weight measured pre and post intervention.
Measured: Baseline and 3 months

Secondary outcomes (9)

Change in Waist Circumference
A secondary outcome for this study will be change in waist circumference, measured pre and post intervention.
Measured: Baseline and 3 months
Change in Total Cholesterol
A secondary outcome for this study will be change in total cholesterol, measured pre and post intervention.
Measured: Baseline and 3 months
Change in HDL Cholesterol
A secondary outcome for this study will be change in HDL cholesterol, measured pre and post intervention.
Measured: Baseline and 3 months
Change in LDL Cholesterol
A secondary outcome for this study will be change in LDL cholesterol, measured pre and post intervention.
Measured: Baseline and 3 months
Change in Fasting Glucose
A secondary outcome for this study will be change in fasting glucose, measured pre and post intervention.
Measured: Baseline and 3 months
Change in Hemoglobin A1C
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..
Measured: Baseline and 3 months
Change in Systolic Blood Pressure
A secondary outcome for this study will be change in systolic blood pressure, measured pre and post intervention.
Measured: Baseline and 3 months
Change in Diastolic Blood Pressure
A secondary outcome for this study will be change in diastolic blood pressure, measured pre and post intervention.
Measured: Baseline and 3 months
Change in Triglycerides
A secondary outcome for this study will be change in Triglyceride level, measured pre and post intervention.
Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007May 2009

First posted31 May 2007 (estimated)
Study startJun 2007
Primary completionMay 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for PrediabetesStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00480779
Sponsor's protocol ID: W81XWH-04-2-0030
Acronym: STEPUP
Status last verified: May 2016
First submitted: 29 May 2007
Last updated: 28 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
PubMed 11832527
Kramer, MK, Miller, R, Venditti, E, Orchard, TO. Group Lifestyle Intervention for Diabetes Prevention in Those with Metabolic Syndrome in Primary Care Practice. Diabetes. June, 2006. 55: Supp., A517.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Screening, Training, Education and Prevention Service of the University of Pittsburgh, Phase 2
ClinicalTrials.gov ID: NCT00480779
Acronym / sponsor ID: STEPUP / W81XWH-04-2-0030
Conditions: Prediabetes, Metabolic Syndrome
Keywords: Prediabetes, Metabolic syndrome, Prevention, Lifestyle intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: United States Department of Defense
Study start: Jun 2007
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 31 May 2007 (estimated)
Results: Posted 28 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
GLB Group	Other	Behavioral: GLB GroupThe 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 DVD	Other	Behavioral: GLB DVDThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

All non-diabetic patients age 18 years and older at the time of enrollment considered to be patients of the practices that are taking part in this project will be eligible for the study upon referral from their physician.
Non-diabetic patients with metabolic syndrome AND/OR pre-diabetes are eligible for the study with referral from their physician based on the following criteria:
All measures should have been taken within six months of enrollment into the study. The physician in each center will be asked to refer eligible patients to the study. It will be the responsibility of the referring physician to determine eligibility and appropriateness of the patient's participation.

Key exclusion criteria (6 listed)

Those patients age less than 18 years old will not be invited to be part of the study. In addition, patients with any of the following conditions are not eligible to take part in the study:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GLB GroupThe 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.	Behavioural	GLB Group
GLB DVDThe 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.	Behavioural	GLB DVD

Primary outcome

Change in Weight
Time frame: Baseline and 3 months
The primary outcome for this study will be change in weight measured pre and post intervention.

9 secondary outcomes

Change in Waist Circumference
Time frame: Baseline and 3 months
Change in Total Cholesterol
Time frame: Baseline and 3 months
Change in HDL Cholesterol
Time frame: Baseline and 3 months
Change in LDL Cholesterol
Time frame: Baseline and 3 months
Change in Fasting Glucose
Time frame: Baseline and 3 months
Change in Hemoglobin A1C
Time frame: Baseline and 3 months
Change in Systolic Blood Pressure
Time frame: Baseline and 3 months
Change in Diastolic Blood Pressure
Time frame: Baseline and 3 months
Change in Triglycerides
Time frame: Baseline and 3 months

Results and safety

Results posted to the registry on 28 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GLB Group	26	24
GLB DVD	22	19

Primary outcome: Change in Weight

Time frame: Baseline and 3 months. Mean (Standard Deviation). Unit: pounds

Measure	GLB Group n = 26	GLB DVD n = 22
Value	-13.9 (14.3)	-11.8 (11.4)

Population analysed: Intent to treat using Last Observation Carried Forward (LOCF)

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GLB Group	0 of 26 (0%)	0 of 26 (0%)	Not reported
GLB DVD	0 of 22 (0%)	0 of 22 (0%)	Not reported

Limitations and caveats (from the sponsor): It should be noted that this was a small pilot study and should be tested in a larger sample.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11832527Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
BackgroundKramer, MK, Miller, R, Venditti, E, Orchard, TO. Group Lifestyle Intervention for Diabetes Prevention in Those with Metabolic Syndrome in Primary Care Practice. Diabetes. June, 2006. 55: Supp., A517.
Diabetes Prevention Support Center of the University of PittsburghLink provided by the sponsor.
A novel approach to diabetes prevention: evaluation of the Group Lifestyle Balance program delivered via DVDLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Trevor J Orchard, MD principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GLB Group and GLB DVD in people with Prediabetes and Metabolic Syndrome, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00480779, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.