PreDiabetesPRIME2NCT03372018
Promotora-Led Intervention for Metabolic and Mental Health
A study testing Promotora-led Intervention (PLI) in people with PreDiabetes and Obesity, run by Northwestern University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Obesity, Metabolic Disease
- What is being tested?
- Promotora-led Intervention (PLI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 22 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promotora 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.
Read the 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.
- Conditions
- PreDiabetes, Obesity, Metabolic Disease, Body Weight Changes, Diabetes Mellitus
- Being tested
- Promotora-led Intervention (PLI), Usual care (UC)
- Medical subject headings
- Prediabetic State, Obesity, Metabolic Diseases, Body Weight Changes, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotora-led Intervention (PLI)Behavioural
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)Behavioural
Participants in this arm will be given educational materials in spanish discussing mental health and diabetes prevention.
| Study group | Role | What they receive |
|---|---|---|
| Promotora-led intervention (PLI) | Experimental | 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. Receives: Behavioral: Promotora-led Intervention (PLI) |
| Usual care (UC) | Active comparator | 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. Receives: Behavioral: Usual care (UC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Weight change from baseline.
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 3 months
Cardiometabolic marker - A1C
Hemoglobin A1C change from baseline measured from a fingerstick capillary blood sample using a DCA 2000/Vantage portable analyzer.
Measured: 3 months
Cardiometabolic marker - waist circumference
Waist circumference change from baseline assessed using a measuring tape around the top of the iliac crests at end-expiration.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start7 Aug 2018
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew J O'Brien, Northwestern University
- Investigators
- Matthew J O'Brien, MD, MSc, Principal investigator, Assistant Professor of Medicine and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372018
- Sponsor's protocol ID
- STU00202244
- Other IDs
- R03DK109243
- Acronym
- PRIME2
- Status last verified
- Jun 2019
- First submitted
- 4 Dec 2017
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotora Intervention for Metabolic and Mental Health
- ClinicalTrials.gov ID
- NCT03372018
- Acronym / sponsor ID
- PRIME2 / STU00202244
- Conditions
- PreDiabetes, Obesity, Metabolic Disease, Body Weight Changes, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Promotora-led intervention (PLI) | Experimental | Behavioral: 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. |
| Usual care (UC) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%)
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Promotora-led intervention (PLI) |
| Usual care (UC)Participants in this arm will be given educational materials in spanish discussing mental health and diabetes prevention. | Behavioural | Usual care (UC) |
Primary outcome
Body Weight
Time frame: 3 months
Weight change from baseline.
4 secondary outcomes
Perceived Stress
Time frame: 3 months
Cardiometabolic marker - A1C
Time frame: 3 months
Cardiometabolic marker - waist circumference
Time frame: 3 months
Beck Depression Inventory
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J O'Brien, MD, MSc principal investigator
Assistant Professor of Medicine and Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotora-led Intervention (PLI) in people with PreDiabetes and Obesity, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.