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Completed

NCT Number: NCT01050205

Diabetes Prevention Translation: the Healthy Lifestyle Project

The Diabetes Prevention Program (DPP), a large research study conducted in the United States, found that lifestyle intervention was effective in lowering risk for development of type 2 diabetes. It is important to evaluate the DPP lifestyle interventions in "real world" settings. The purpose of this project is to test an adapted version of the DPP lifestyle intervention in several community settings, including a worksite, a health care facility (primary care practice and local community centers dedicated to older adults.

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Key information

Conditions

Diabetes Cardiovascular Risk Factor Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

Evidence that lifestyle intervention can prevent or delay the development of type 2 diabetes has been demonstrated in several clinical trials including a multi center clinical trial in the US, the Diabetes Prevention Program (DPP). The challenge for public health is to translate this promising and proven behavioral intervention utilized in the DPP research effort to the "real world", i.e., how to make it work in diverse communities in a variety of local settings at a reduced cost so that the maximal number of those at risk can benefit.

The purpose of this application is to test a framework for translation of the DPP that includes: 1) demonstration of a training model for community health care professionals that includes initial training, support, and supervision in the delivery of a diabetes prevention curriculum and the needed behavioral lifestyle materials both initially and over time; 2) evaluation of a more compact and flexible DPP intervention program administered to each participant in a version of his or her choice (standard face-to-face group format or a DVD version of the same lifestyle intervention program content). These lifestyle intervention programs will be carried out in three different community settings; i.e. a health care practice, a worksite, and local centers in the community dedicated to healthy aging for older adults. Lastly, the cost-effectiveness analyses of the GLB intervention program in each of the three community settings will be tested.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Screening Eligibility Criteria: Non-diabetic men and women from the specific study sites in the local area who are age 18 years and older at the time of screening with a BMI of at least 25 kg/m2 are eligible for screening.
  • Intervention Eligibility Criteria: Individuals attending screening who are found to have prediabetes AND/OR metabolic syndrome are eligible to participate in the intervention. Pre-diabetes is defined as having a fasting glucose >100 mg/dL and <126mg/dL. Metabolic syndrome is defined as having at least 3 of the 5 following risk factors:
  • 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)
  • Elevated triglyceride level >150 mg/dL
  • Fasting glucose >100mg/dL and <126mg/dL All individuals enrolled in the study should have at least 6th grade reading/writing ability.

Exclusion criteria

  • Screening Exclusionary Criteria: Women who are currently (or within past 6-weeks) pregnant or lactating, or any individual planning to leave the area before the end of the effort will be considered ineligible to participate in the screening.
  • Intervention Exclusionary Criteria: Exclusionary criterion for intervention is the same as for screening. In addition, individuals who are on metformin or are identified as having diabetes as a result of the screening are not eligible. Individuals who have recently (within the past 3 months) initiated or changed their dosage of any blood pressure or lipid medication will also be excluded as being on an unstable regimen will complicate the interpretation of any blood pressure or lipid effects of the intervention.

Treatment and study plan

Current Intervention

Behavioral

Participants assigned to Current Intervention will receive the intervention described below immediately after randomization. The one-year GLB program is an adaptation of the successful DPP lifestyle intervention. The goals of the intervention are to achieve and maintain a 7% weight loss, and to safely and progressively increase physical activity to 150 minutes per week of moderately intense physical activity.

GLB-GROUP: group meetings weekly transitioning to monthly over one year led by a trained coach. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the GLB program. GLB-DVD participants complete the sessions via DVD and have telephonic contact with their coach as well as monthly group meetings.

Delayed Intervention

Behavioral

Participants assigned to Delayed Intervention receive the same intervention as Current Intervention Group, 6 months from randomization. The one-year GLB program is an adaptation of the successful DPP lifestyle intervention. The goals of the intervention are to achieve and maintain a 7% weight loss, and to safely and progressively increase physical activity to 150 minutes per week of moderately intense physical activity.

GLB-GROUP: group meetings weekly transitioning to monthly over one year led by a trained coach. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the GLB program. GLB-DVD participants complete the sessions via DVD and have telephonic contact with their coach as well as monthly group meetings.

Primary outcomes

  1. Changes in Weight Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.

    Time frame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)

    Weight was measured twice using a digital physician's scale (DETECTO® PD100) placed on a hard, flat surface. Participants were asked to remove their shoes and stand in the middle of the scale with eyes straight forward and without touching any surface. The participant was asked to step down from the scale between measures. If the measures were more than 0.5 pounds apart, a third measure was taken. Weight is reported in pounds.

Secondary outcomes

  1. Changes in Fasting Glucose Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.

    Time frame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)

    After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.

  2. Changes in Fasting Insulin Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.

    Time frame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)

    Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.

  3. Changes in Fasting Lipids (Total Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.

    Time frame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)

    Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the work site and community/senior centers.

  4. Changes in Fasting Lipids (Triglycerides) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.

    Time frame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)

    Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.

  5. Changes in Fasting Lipids (HDL Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.

    Time frame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)

    Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.

  6. Changes in Fasting Lipids (LDL Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.

    Time frame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)

    Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.

  7. Changes in A1c Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.

    Time frame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)

    Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers. A1c is a measure of glucose control over approximately an 8 to 12 week period.

  8. Changes in Systolic Blood Pressure (BP) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.

    Time frame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)

    Blood pressure was measured in the right arm with the participant seated comfortably with the right arm resting on a table. All participants were asked to rest quietly with feet flat on the floor for five minutes. Following the five minute wait, the radial pulse was measured in the right arm and pulse obliteration level was assessed. The cuff was inflated to the peak inflation rate and the pressure released at a rate of 2mm/Hg per second. First appearance and last heard (phase V) Korotkoff's sounds were utilized to determine systolic and diastolic blood pressure respectively. The cuffed arm was then raised for 5 seconds after each inflation with a wait period of 30 seconds between each blood pressure reading. Blood pressure was repeated twice with the average computed. If it was not possible to measure blood pressure in the right arm, the left arm was utilized and noted in the participant record.

  9. Changes in Waist Circumference Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.

    Time frame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)

    The participant was asked stand with feet together. The waist was measured using a cloth measuring tape around the abdomen. The midpoints were marked horizontally at midpoint between highest point of the iliac crest and lowest part of the costal margin in the mid-axillary line. Both sides of the waist were marked using a cosmetic pencil. The participant was asked to have arms at side and to breathe in, out and hold, and then the measurement was taken. Waist measurement was recorded to the nearest quarter inch. The measure was repeated twice. If waist measures differ by more than one-half inch, a third measurement was recorded.

  10. Changes in Self-reported Physical Activity Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.

    Time frame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)

    The Modifiable Activity Questionnaire (MAQ) was designed by Dr. Kriska. It has been used to assess activity in a variety of populations and age groups over various time frames and was used to assess physical activity levels in the DPP. The MAQ includes both a leisure and an occupational activity section since the homogeneity of energy expenditure related to both of these components of activity within many study populations cannot be assumed. In addition, the MAQ was designed to be modified, based upon pilot testing, prior to its usage, in order to maximize the feasibility and appropriateness of the physical activity instrument to the population of interest. The MAQ has been shown to be both reliable and valid (through comparisons with activity monitors, fitness (field) testing, and the doubly labeled water technique) in adults and adolescents alike. The MAQ has been used to assess a variety of time frames from past year and past week to a lifetime of activity.

  11. Changes in Diastolic Blood Pressure (BP) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.

    Time frame: Baseline and post-intervention (assessed at 6 months after commencement of intervention)

    Blood pressure was measured in the right arm with the participant seated comfortably with the right arm resting on a table. All participants were asked to rest quietly with feet flat on the floor for five minutes. Following the five minute wait, the radial pulse was measured in the right arm and pulse obliteration level was assessed. The cuff was inflated to the peak inflation rate and the pressure released at a rate of 2mm/Hg per second. First appearance and last heard (phase V) Korotkoff's sounds were utilized to determine systolic and diastolic blood pressure respectively. The cuffed arm was then raised for 5 seconds after each inflation with a wait period of 30 seconds between each blood pressure reading. Blood pressure was repeated twice with the average computed. If it was not possible to measure blood pressure in the right arm, the left arm was utilized and noted in the participant record.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Diabetes Prevention Translation Project: the Healthy Lifestyle Project

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jan 15, 2010
Registry last updated
Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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