Back to resultsPromotora-Led Intervention for Metabolic and Mental Health (PRIME2)
Primary Purpose
PreDiabetes, Obesity, Metabolic Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Promotora-led Intervention (PLI)
Usual care (UC)
Sponsored by
About this trial
This is an interventional treatment trial for PreDiabetes
Eligibility Criteria
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).
Sites / Locations
- Northwestern Univeristy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Promotora-led intervention (PLI)
Usual care (UC)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Body Weight
Weight change from baseline.
Secondary Outcome Measures
Perceived Stress
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.
Cardiometabolic marker - A1C
Hemoglobin A1C change from baseline measured from a fingerstick capillary blood sample using a DCA 2000/Vantage portable analyzer.
Cardiometabolic marker - waist circumference
Waist circumference change from baseline assessed using a measuring tape around the top of the iliac crests at end-expiration.
Beck Depression Inventory
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.
Full Information
NCT ID
NCT03372018
First Posted
December 4, 2017
Last Updated
June 3, 2019
Sponsor
Northwestern University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT03372018
Brief Title
Promotora-Led Intervention for Metabolic and Mental Health
Acronym
PRIME2
Official Title
Promotora Intervention for Metabolic and Mental Health
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
March 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Obesity, Metabolic Disease, Body Weight Changes, Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Promotora-led intervention (PLI)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care (UC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Promotora-led Intervention (PLI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care (UC)
Intervention Description
Participants in this arm will be given educational materials in spanish discussing mental health and diabetes prevention.
Primary Outcome Measure Information:
Title
Body Weight
Description
Weight change from baseline.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Perceived Stress
Description
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.
Time Frame
3 months
Title
Cardiometabolic marker - A1C
Description
Hemoglobin A1C change from baseline measured from a fingerstick capillary blood sample using a DCA 2000/Vantage portable analyzer.
Time Frame
3 months
Title
Cardiometabolic marker - waist circumference
Description
Waist circumference change from baseline assessed using a measuring tape around the top of the iliac crests at end-expiration.
Time Frame
3 months
Title
Beck Depression Inventory
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J O'Brien, MD, MSc
Organizational Affiliation
Assistant Professor of Medicine and Preventive Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Univeristy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Promotora-Led Intervention for Metabolic and Mental Health
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