Promotora-Led Intervention for Metabolic and Mental Health

Obesity Clinical Trial

— PRIME2  

Official title:

Promotora Intervention for Metabolic and Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372018
• Other study ID #: STU00202244
• Secondary ID: R03DK109243
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: March 22, 2019

Study information

• Verified date: June 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 22, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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, ß-blockers, and systemic glucocorticoids).

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Diabetes Mellitus
• Metabolic Disease
• Metabolic Diseases
• Obesity
• PreDiabetes
• Prediabetic State

Intervention

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.
• Usual care (UC)
Participants in this arm will be given educational materials in spanish discussing mental health and diabetes prevention.

Locations

Country	Name	City	State
United States	Northwestern Univeristy	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight	Weight change from baseline.	3 months
Secondary	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.	3 months
Secondary	Cardiometabolic marker - A1C	Hemoglobin A1C change from baseline measured from a fingerstick capillary blood sample using a DCA 2000/Vantage portable analyzer.	3 months
Secondary	Cardiometabolic marker - waist circumference	Waist circumference change from baseline assessed using a measuring tape around the top of the iliac crests at end-expiration.	3 months
Secondary	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.	3 months