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NCT Number: NCT03372018

Promotora-Led Intervention for Metabolic and Mental Health

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.

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Key information

Conditions

PreDiabetes Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Disease Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Univeristy

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

Promotora-led Intervention (PLI)

Behavioral

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.

Usual care (UC)

Behavioral

Participants in this arm will be given educational materials in spanish discussing mental health and diabetes prevention.

Primary outcomes

  1. Body Weight

    Time frame: 3 months

    Weight change from baseline.

Secondary outcomes

  1. Perceived Stress

    Time frame: 3 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: 3 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: 3 months

    Waist circumference change from baseline assessed using a measuring tape around the top of the iliac crests at end-expiration.

  4. Beck Depression Inventory

    Time frame: 3 months

    levated depressive symptoms were assessed using the Beck Depression Inventory (BDI), a depression screening instrument. The BDI score recorded at the enrollment visit will be considered the baseline BDI score. The last measured BDI score within 3 months after the baseline visit is the follow-up score used to calculate mean BDI change.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

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

Registry information

Official study title

Promotora Intervention for Metabolic and Mental Health

Acronym: PRIME2

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2017
Registry last updated
Jun 5, 2019

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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