Promotora-Led Intervention for Metabolic and Mental Health (PRIME2)
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|ClinicalTrials.gov Identifier: NCT03372018|
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : August 22, 2018
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- Body Weight [ Time Frame: 6 months ]Weight change from baseline.
- 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.
- 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.
- 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.
- Physical activity [ Time Frame: 6 months ]Participants' weekly self-monitoring logs used to provide a crude measure of physical activity (minutes per week).
- 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.
- Dietary intake [ Time Frame: 6 months ]Participants' weekly self-monitoring logs used to provide a crude measure of dietary intake.
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 ClinicalTrials.gov identifier (NCT number): NCT03372018
|Contact: Matthew J O'Brienemail@example.com|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Maria Vargas 312-503-7419 firstname.lastname@example.org|
|Principal Investigator:||Matthew J O'Brien, MD, MSc||Assistant Professor of Medicine and Preventive Medicine|