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Promotora-Led Intervention for Metabolic and Mental Health (PRIME2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03372018
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : August 22, 2018
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Northwestern University

Brief Summary:
Evidence-based programs to prevent diabetes among high-risk individuals are less effective among those who also have mental health needs. This study involves developing and pilot testing the first adaptation of the landmark Diabetes Prevention Program lifestyle intervention to simultaneously treat prediabetes and elevated mental health symptoms. This project has large potential to impact public health, given that more than half of the U.S. adult population has either of these conditions, and is at risk for developing comorbid diabetes and mental illness.

Condition or disease Intervention/treatment Phase
PreDiabetes Obesity Metabolic Disease Body Weight Changes Diabetes Mellitus Behavioral: Promotora-led Intervention (PLI) Behavioral: Usual care (UC) Not Applicable

Detailed Description:
The overall goal of this study is to develop an effective and potentially scalable intervention to prevent diabetes in people with elevated mental health symptoms (EMS) and prediabetes. This study focuses on Latinos, a demographic group at particularly high risk for these related conditions. Experience from the Diabetes Prevention Program (DPP), and related translational studies, suggests that the evidence-based DPP lifestyle intervention is less effective among depressed individuals. The proposed Promotora Intervention for Metabolic and Mental Health (PRIME2) will be the first adaptation of the DPP lifestyle intervention to simultaneously address mental health and prediabetes in a program delivered by promotoras, or community health workers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Promotora Intervention for Metabolic and Mental Health
Actual Study Start Date : August 6, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Promotora-led intervention (PLI)
PLI -DPP protocol was developed from original DPP materials and culturally tailored for the target population based on formative research. The core PL-DPP curriculum includes 14 group sessions of 90 minutes duration. One promotora will lead each session in Spanish using behavioral strategies to discuss lifestyle behaviors, exploring such topics as being active, low-fat diets, portion control, self monitoring, problem solving and life-style changes.
Behavioral: Promotora-led Intervention (PLI)
Behavioral life-style program with cognitive-behavioral content lead by a team of trained community health workers (called promotoras) with the following principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week.

Active Comparator: Usual care (UC)
UC participants will receive standard educational materials in Spanish discussing mental health and diabetes prevention. UC participants will be encouraged to continue all routine medical care during the study.
Behavioral: Usual care (UC)
Participants in this arm will be given educational materials in spanish discussing mental health and diabetes prevention.

Primary Outcome Measures :
  1. Body Weight [ Time Frame: 6 months ]
    Weight change from baseline.

Secondary Outcome Measures :
  1. Perceived Stress Scale (PSS) [ Time Frame: 6 months ]

    The Perceived Stress Scale (PSS) is a 14-item tool meant to measure how different situations affect participant feelings and perceived stress. Individual scores on the PSS range from 0 to 40 with higher scores indicating higher perceived stress. Each item is rated on a 5-point scale ranging from never (0) to almost always (4).The total score reported for each participant.

    • Scores ranging from 0-13 would be considered low stress.
    • Scores ranging from 14-26 would be considered moderate stress.
    • Scores ranging from 27-40 would be considered high perceived stress.

  2. Cardiometabolic marker - A1C [ Time Frame: 6 months ]
    Hemoglobin A1C change from baseline measured from a fingerstick capillary blood sample using a DCA 2000/Vantage portable analyzer.

  3. Cardiometabolic marker - waist circumference [ Time Frame: 6 months ]
    Waist circumference change from baseline assessed using a measuring tape around the top of the iliac crests at end-expiration.

  4. Physical activity [ Time Frame: 6 months ]
    Participants' weekly self-monitoring logs used to provide a crude measure of physical activity (minutes per week).

  5. Physical Activity and Nutrition Self-Efficacy (PANSE) scale [ Time Frame: 6 months ]
    Weight loss self efficacy measured with the 11-item PANSE instrument. The PANSE was designed to address both nutrition and physical activity - a single brief instrument to assess self-efficacy for weight loss behaviors. Each item is rated on a 9-point scale ranging from not all (0) to completely (9).The total score reported for each participant. Low PANSE score indicates low self-efficacy.

  6. Dietary intake [ Time Frame: 6 months ]
    Participants' weekly self-monitoring logs used to provide a crude measure of dietary intake.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Latino ethnicity
  • Spanish fluency
  • Age ≥18 years
  • BMI ≥25 kg/m2
  • And "increased risk of diabetes" (ADA Diabetes Risk Score ≥5 as determined by 7-item questionnaire and/or hemoglobin A1C ≥ 5.7%)

Exclusion Criteria:

  • Hemoglobin A1C ≥ 6.5%
  • Current or planned pregnancy during the study period
  • Chronic conditions that could affect potential participants' ability to participate (osteoarthritis, heart disease, pulmonary disease requiring oxygen or daily bronchodilator use, and severe psychiatric disease)
  • Medical comorbidities that could influence weight loss or weight gain (thyroid disease, cancer, and HIV)
  • Medications that could affect weight or glucose metabolism (thiazide diuretics, β-blockers, and systemic glucocorticoids).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03372018

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Contact: Matthew J O'Brien 312-503-7419

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United States, Illinois
Northwestern Univeristy Recruiting
Chicago, Illinois, United States, 60611
Contact: Maria Vargas    312-503-7419   
Sponsors and Collaborators
Northwestern University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Matthew J O'Brien, MD, MSc Assistant Professor of Medicine and Preventive Medicine

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Responsible Party: Northwestern University Identifier: NCT03372018     History of Changes
Other Study ID Numbers: STU00202244
R03DK109243 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Body Weight
Prediabetic State
Metabolic Diseases
Body Weight Changes
Glucose Metabolism Disorders
Endocrine System Diseases
Signs and Symptoms