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Completed

NCT Number: NCT00656682

Primary Care Community Partnerships to Prevent Diabetes

The purpose of this study is to determine if providing free-of-charge access to a group-based lifestyle intervention delivered in partnership with the community is cost-effective for the prevention of type 2 diabetes.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

Randomized controlled trials have shown that modest lifestyle changes can prevent or delay the onset of diabetes in adults with pre-diabetes. Unfortunately, despite the increasing prevalence of pre-diabetes and diabetes in all facets of the population, intervention programs needed to achieve these goals are costly and remain unavailable in most clinical settings. Over the past 3 years, we have demonstrated the feasibility of training community instructors to deliver a group-based adaptation of the Diabetes Prevention Program (DPP) lifestyle intervention. In this pilot research, this new delivery model achieves a level of weight reduction that was associated with diabetes prevention and improved cardiometabolic risk factor control in the DPP. This new, large-scale randomized effectiveness trial is designed to evaluate the costs and effectiveness of a partnered approach to identify adults with pre-diabetes in primary care settings, deliver brief advice for diabetes prevention, and provide access to a group-based adaptation of the DPP lifestyle intervention offered by the community. This study will compare costs and outcomes to a standard care, brief clinical counseling approach delivered by Registered Dietitians.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older
  • Body-mass index of 24 kg/m2 or greater
  • Fasting Blood Glucose 100 - 125 mg/dl, OR 2-hour Post-challenge Capillary Glucose 140 - 199 mg/dl

Exclusion criteria

  • Cancer requiring treatment in the past 5 years
  • Uncontrolled hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg
  • Heart attack, stroke, or transient ischemic attack in the past 6 months,
  • Chronic obstructive airways disease or asthma requiring home oxygen
  • Other chronic disease or condition, such as advanced arthritis, that could limit ability to become physically active or limit life span to <5 years
  • Pregnancy
  • Existing diagnosis of diabetes mellitus
  • Fasting capillary blood glucose > 125 mg/dl
  • 2-hour post-challenge capillary blood glucose > 199 mg/dl
  • History of anti-diabetic medication use (oral agents or insulin) except during gestational diabetes
  • Self-report of a medication known to lead to hyperglycemia (oral steroids, antipsychotics, anti-epileptics)
  • Self-report of disease associated with disordered glucose metabolism: Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis

Treatment and study plan

Dietitian Counseling Alone

Behavioral

Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian

Dietitian Plus Community Group Lifestyle

Behavioral

Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based lifestyle intervention offered by the Community to prevent diabetes

Primary outcomes

  1. % Change in Body Weight

    Time frame: 12 months

    (weight in kg at 12 months - weight in kg at baseline) / (weight in kg at baseline)

Secondary outcomes

  1. % Change in Blood Total Cholesterol

    Time frame: 12 months

    (total blood cholesterol concentration at 12 months - total blood cholesterol concentration at baseline) / (total blood cholesterol concentration at baseline)

  2. % Change in glycosylated hemoglobin

    Time frame: 12 months

    (HbA1c % at 12 months - HbA1c % at baseline) / (HbA1c % at baseline)

  3. % Change in Blood Pressures

    Time frame: 12 months

    (mean SBP at 12 months - mean SBP at baseline) / (mean SBP at baseline); (mean DBP at 12 months - mean DBP at baseline) / (mean DBP at baseline)

  4. Changes in Dietary Composition

    Time frame: 12 months

    NHIS Multifactor Screener: Change in % dietary kcal from fat at 12 months (est % dietary Kcal from fat at 12 months - est % dietary Kcal from fat at baseline)

  5. Changes in Physical Activity

    Time frame: 12 months

    Paffenbarger PAQ: (Total Kcal/week energy expenditure from walking, stairs, and leisure time activity at 12 months - Total Kcal/week energy expenditure from walking, stairs, and leisure time activity at Baseline)

  6. Incremental Costs

    Time frame: 12 months

  7. Incremental Health State Utility

    Time frame: 12 months

  8. % Change in Body Weight

    Time frame: 6 months

    (weight in kg at 6 months - weight in kg at baseline) / (weight in kg at baseline)

  9. % Change in Body Weight

    Time frame: 24 months

    (weight in kg at 24 months - weight in kg at baseline) / (weight in kg at baseline)

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

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

Registry information

Acronym: RAPID

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Apr 11, 2008
Registry last updated
Mar 29, 2018

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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