DiabetesNCT00869609
Evaluation of Group Lifestyle Balance Maintenance Strategies
A study testing GLB Traditional Maintenance (TM) and GLB-Carb-focused Maintenance (CF) in people with Diabetes, run by University of Pittsburgh at 1 site in United States.
Trial summary
Heart disease is a leading cause of death in people in the United States. It is a major problem for those with diabetes. Conditions called the metabolic syndrome and pre-diabetes increase risk for diabetes and heart disease. The metabolic syndrome is a group of disorders that occur at the same time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- GLB Traditional Maintenance (TM) and GLB-Carb-focused Maintenance (CF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Aug 2010
- 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
- Non-diabetic patients with metabolic syndrome AND/OR pre-diabetes are eligible for this project based on the following criteria:
- Metabolic Syndrome:
- Patients with BMI ≥ 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 ≥130 mmHg (systolic) or ≥85 mmHg (diastolic) OR history of diagnosed hypertension
- Low HDL level (<40mg/dL men, <50 mg/dL women)
Show all 11Show fewer
- Elevated triglyceride level ≥150 mg/dL
- Fasting glucose ≥100mg/dL and <126mg/dL
- Pre-diabetes:
- Patients with a BMI ≥25 kg/m2 and pre-diabetes (fasting glucose ≥100 mg/dL and <126mg/dL)
- All measures should have been taken within one year of enrollment into the study. A permission for physical activity form must be signed by the participant's physician in order to take part in the study.
Who cannot join
- Previous diabetes or diabetes diagnosed as a result of the screening
- Age <18 years old
- 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 GILS
- Any patient who is unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes Prevention Support Center
Pittsburgh, Pennsylvania, 15213
About this study
Heart disease is a leading cause of death in people in the United States. It is a major problem for those with diabetes. Conditions called the metabolic syndrome and pre-diabetes increase risk for diabetes and heart disease. The metabolic syndrome is a group of disorders that occur at the same time. Overall, one in four American adults has the metabolic syndrome. It is more common in people over the age of 40. The metabolic syndrome includes: 1) large waist size, 2) high triglycerides, 3) low HDL cholesterol, 4) high blood pressure and 5) high fasting blood sugar. People with the metabolic syndrome have at least three of these five risk factors. Pre-diabetes is considered to be present in those with high fasting blood sugar levels below the diabetes range.
Research has shown that type 2 diabetes and the metabolic syndrome may be prevented or delayed by making lifestyle changes. It is not known what will most help people continue these healthy changes over time. The purpose of this study is to look at ways to help people continue the healthy lifestyle changes they have made while taking part in a diabetes prevention program called Group Lifestyle Balance (GLB).
Read the detailed description
Objective: To determine the effectiveness of the Group Lifestyle Balance (GLB) program with an added maintenance component focusing on carbohydrate reduction and hunger management when compared to the GLB program with traditional maintenance.
Research Design and Methods: The original Diabetes Prevention Program intervention was modified from a 16 session individual intervention to a 12 session group-based program called Group Lifestyle Balance (GLB). The Diabetes Prevention Support Center (DPSC) has been created to oversee the implementation of diabetes prevention and CVD risk reduction in various community settings. GLB is a 12-session group based program that focuses on a low fat diet, weight loss and physical activity. This evidence-based intervention is directed at those with pre-diabetes and/or the metabolic syndrome. A monthly maintenance component will be added which provides support in assisting individuals who have completed the 12-session course in the maintenance of healthy lifestyle changes.
The efficacy (in terms of weight reduction) of an added maintenance component focusing on carbohydrate reduction and hunger management will be compared to traditional maintenance. Participants will be randomly assigned to either GLB traditional maintenance (GLB-TM) or GLB and carbohydrate reduced maintenance (GLB-CRM). There will be two groups of approximately 15 subjects in each intervention assignment, for a total of approximately 30 subjects per intervention group and approximately 60 subjects taking part overall. Efficacy in both groups will be assessed by pre and post-intervention measures of diet (weight loss) and physical activity (the keystones of the intervention), as well as the achievement of the two goals: a 7% weight loss by the end of 6 months and 150 minutes of physical activity per week. Secondary outcomes to be evaluated include the reduction of global CVD risk, as assessed by the Framingham Score, the presence of metabolic syndrome (NCEP ATP III), and a fall in blood sugar. Repeat measures will be obtained at six months and one year for further evaluation and comparison.
- Conditions
- Diabetes
- Being tested
- GLB Traditional Maintenance (TM), GLB-Carb-focused Maintenance (CF)
- Keywords
- Diabetes Prevention, CVD Risk Reduction, Lifestyle Intervention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLB Traditional Maintenance (TM)Behavioural
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
GLB-Carb-focused Maintenance (CF)Behavioural
After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management.
| Study group | Role | What they receive |
|---|---|---|
| GLB Traditional Maintenance (TM) | Active comparator | Group Lifestyle Balance (GLB) program Traditional Maintenance: After completion of the GLB 12 core sessions, participants who are randomly assigned to GLB program Traditional Maintenance (TM) will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. Receives: Behavioral: GLB Traditional Maintenance (TM) |
| GLB-Carb-focused Maintenance (CF) | Active comparator | Group Lifestyle Balance (GLB) program Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants randomly assigned to GLB Carb-focused Maintenance (CF) will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management. Receives: Behavioral: GLB-Carb-focused Maintenance (CF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Weight was measured twice without shoes with the average computed; participants were asked to remove their shoes at each measure.
Measured: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Secondary outcomes (9)
Change in Total Cholesterol
Total cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.
Measured: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in HDL Cholesterol
High-density lipoprotein (HDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.
Measured: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in LDL Cholesterol
Low-density lipoprotein (LDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.
Measured: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Triglycerides
Triglycerides were measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.
Measured: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Fasting Glucose
Fasting plasma glucose was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.
Measured: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Glycosylated Hemoglobin A1c (HbA1c)
Collected via venous blood draw, the HbA1c level reflects glucose concentration over the previous period (approximately 8-12 weeks, depending on the individual) and provides an indication of long-term glycemic control.
Measured: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Systolic Blood Pressure
Blood pressure was measured in a sitting position in the right arm after resting for five minutes. First appearance and last heard (phase V) Korotkoff's sounds were used to define the pressure readings; the measures were repeated twice with a thirty second wait between each reading.
Measured: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Diastolic Blood Pressure
Blood pressure was measured in a sitting position in the right arm after resting for five minutes. First appearance and last heard (phase V) Korotkoff's sounds were used to define the pressure readings; the measures were repeated twice with a thirty second wait between each reading.
Measured: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Waist Circumference
Waist circumference was measured at the midpoint between the lower rib margin and the iliac crest; the measurement was repeated twice and the average computed.
Measured: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2010
- Study completionAug 2010
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.
- Other trials for DiabetesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Robert C. Atkins Foundation
- Responsible party
- Principal investigator, Trevor J. Orchard, University of Pittsburgh
- Investigators
- Trevor J Orchard, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869609
- Sponsor's protocol ID
- PRO08120047
- Status last verified
- May 2016
- First submitted
- 24 Mar 2009
- Last updated
- 24 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Group Lifestyle Balance Maintenance Strategies
- ClinicalTrials.gov ID
- NCT00869609
- Acronym / sponsor ID
- PRO08120047
- Conditions
- Diabetes
- Keywords
- Diabetes Prevention, CVD Risk Reduction, Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Robert C. Atkins Foundation
- Study start
- Mar 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Posted 9 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart disease is a leading cause of death in people in the United States. It is a major problem for those with diabetes. Conditions called the metabolic syndrome and pre-diabetes increase risk for diabetes and heart disease. The metabolic syndrome is a group of disorders that occur at the same time. Overall, one in four American adults has the metabolic syndrome. It is more common in people over the age of 40. The metabolic syndrome includes: 1) large waist size, 2) high triglycerides, 3) low HDL cholesterol, 4) high blood pressure and 5) high fasting blood sugar. People with the metabolic syndrome have at least three of these five risk factors. Pre-diabetes is considered to be present in those with high fasting blood sugar levels below the diabetes range.
Research has shown that type 2 diabetes and the metabolic syndrome may be prevented or delayed by making lifestyle changes. It is not known what will most help people continue these healthy changes over time. The purpose of this study is to look at ways to help people continue the healthy lifestyle changes they have made while taking part in a diabetes prevention program called Group Lifestyle Balance (GLB).
Detailed description
Objective: To determine the effectiveness of the Group Lifestyle Balance (GLB) program with an added maintenance component focusing on carbohydrate reduction and hunger management when compared to the GLB program with traditional maintenance.
Research Design and Methods: The original Diabetes Prevention Program intervention was modified from a 16 session individual intervention to a 12 session group-based program called Group Lifestyle Balance (GLB). The Diabetes Prevention Support Center (DPSC) has been created to oversee the implementation of diabetes prevention and CVD risk reduction in various community settings. GLB is a 12-session group based program that focuses on a low fat diet, weight loss and physical activity. This evidence-based intervention is directed at those with pre-diabetes and/or the metabolic syndrome. A monthly maintenance component will be added which provides support in assisting individuals who have completed the 12-session course in the maintenance of healthy lifestyle changes.
The efficacy (in terms of weight reduction) of an added maintenance component focusing on carbohydrate reduction and hunger management will be compared to traditional maintenance. Participants will be randomly assigned to either GLB traditional maintenance (GLB-TM) or GLB and carbohydrate reduced maintenance (GLB-CRM). There will be two groups of approximately 15 subjects in each intervention assignment, for a total of approximately 30 subjects per intervention group and approximately 60 subjects taking part overall. Efficacy in both groups will be assessed by pre and post-intervention measures of diet (weight loss) and physical activity (the keystones of the intervention), as well as the achievement of the two goals: a 7% weight loss by the end of 6 months and 150 minutes of physical activity per week. Secondary outcomes to be evaluated include the reduction of global CVD risk, as assessed by the Framingham Score, the presence of metabolic syndrome (NCEP ATP III), and a fall in blood sugar. Repeat measures will be obtained at six months and one year for further evaluation and comparison.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLB Traditional Maintenance (TM) | Active comparator | Behavioral: GLB Traditional Maintenance (TM)Group Lifestyle Balance (GLB) program Traditional Maintenance: After completion of the GLB 12 core sessions, participants who are randomly assigned to GLB program Traditional Maintenance (TM) will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. |
| GLB-Carb-focused Maintenance (CF) | Active comparator | Behavioral: GLB-Carb-focused Maintenance (CF)Group Lifestyle Balance (GLB) program Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants randomly assigned to GLB Carb-focused Maintenance (CF) will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Non-diabetic patients with metabolic syndrome AND/OR pre-diabetes are eligible for this project based on the following criteria:
- Metabolic Syndrome:
- Patients with BMI ≥ 25 kg/m2, with at least 3 of the following risk factors for metabolic syndrome:
- Pre-diabetes:
- Patients with a BMI ≥25 kg/m2 and pre-diabetes (fasting glucose ≥100 mg/dL and <126mg/dL)
Key exclusion criteria (6 listed)
- Previous diabetes or diabetes diagnosed as a result of the screening
- Age <18 years old
- 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 GILS
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 Traditional Maintenance (TM)After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management. | Behavioural | GLB Traditional Maintenance (TM) |
| GLB-Carb-focused Maintenance (CF)After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management. | Behavioural | GLB-Carb-focused Maintenance (CF) |
Primary outcome
Change in Weight
Time frame: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Weight was measured twice without shoes with the average computed; participants were asked to remove their shoes at each measure.
9 secondary outcomes
Change in Total Cholesterol
Time frame: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in HDL Cholesterol
Time frame: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in LDL Cholesterol
Time frame: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Triglycerides
Time frame: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Fasting Glucose
Time frame: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Glycosylated Hemoglobin A1c (HbA1c)
Time frame: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Systolic Blood Pressure
Time frame: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Diastolic Blood Pressure
Time frame: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Change in Waist Circumference
Time frame: Measured at 8 months post intervention and 4 months post-randomization to maintenance group
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Diabetes Prevention Support Center of the University of PittsburghLink provided by the sponsor.
- Long-term Strategies for Diabetes Prevention: Evaluation of the Group Lifestyle Balance Post-Core Sessions Focusing on Carbohydrate and Hunger ManagementLink 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 Traditional Maintenance (TM) and GLB-Carb-focused Maintenance (CF) in people with Diabetes, 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 11 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 24 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 9 Feb 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: Measured at 8 months post intervention and 4 months post-randomization to maintenance group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2016.