DiabetesPhase 4NCT02088034
Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
A Phase 4 study testing Promotora-led Intervention and Metformin Therapy in people with Diabetes, run by Temple University at 1 site in United States.
Trial summary
The overarching goal of this project is to develop and test a behavioral intervention delivered by promotoras to help at-risk Latinas lose weight and prevent diabetes. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Diabetes
- What is being tested?
- Promotora-led Intervention and Metformin Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Feb 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female gender
- Latino ethnicity
- Spanish fluency
- Age ≥20 years
- BMI ≥25 kg/m2
- And "increased risk of diabetes" (ADA Diabetes Risk Score ≥4 as determine by 7-item questionnaire and hemoglobin A1C ≥ 5.6%)
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.
United States1 site
Temple University - Center for Obesity Research and Education
Philadelphia, Pennsylvania, 19140
About this study
Official title: Promotora-led Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
The overarching goal of this project is to develop and test a behavioral intervention delivered by promotoras to help at-risk Latinas lose weight and prevent diabetes.
Read the detailed description
The goal of the proposed research is to compare two evidence-based strategies for preventing type 2 diabetes - promotora-led lifestyle intervention and metformin - vs. usual care (UC) among Latinas in a "real world" setting. The aims of this study are to 1) develop a protocol-based, promotora-led lifestyle intervention (PLI) to promote weight loss in at-risk Latinas, and assess its feasibility; 2) compare changes in weight and cardiometabolic markers-hemoglobin A1C, fasting lipids, blood pressure-from baseline to 1 year between at-risk Latinas randomly assigned to the PLI group versus metformin and usual care (UC) groups; and 3) understand the social and cultural context surrounding weight-related behaviors among Latinas at-risk for diabetes. The investigators hypothesize that Latinas assigned to PLI and metformin will have greater weight loss (primary outcome) and greater improvements in cardiometabolic markers from baseline to 1 year than those randomized to UC
- Conditions
- Diabetes
- Being tested
- Promotora-led Intervention, Metformin Therapy, Usual Care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotora-led InterventionBehavioural
Also called ILI
Behavioral life-style program lead by a team of trained community health workers (called promotoras) with 2 principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week.
Metformin TherapyDrug
Also called Metformin
Participants in this group will receive metformin 850 mg bid for one year.
Usual CareOther
Also called Control
Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.
| Study group | Role | What they receive |
|---|---|---|
| Promotora-led Intervention | Experimental | The Promotora-led Intervention consists of a core curriculum or 12 group sessions of 90 minute duration over a 12-week period and will be followed by a maintenance phase of 10 biweekly and then monthly 90-minute sessions during months 4 through 12. One promotora will lead each session in Spanish, exploring such topics as being active, low-fat diets, portion control, self monitoring, problem solving and life-style changes. Receives: Behavioral: Promotora-led Intervention |
| Usual care | Active comparator | One physician visit at Puentes de Salud or Congreso Health Center to discuss healthy lifestyle behaviors that promote weight loss and diabetes prevention. During that visit, UC participants will also receive standard educational materials in Spanish from the NIDDK Weight-control Information Network covering the same topics. UC participants will receive another physician visit upon completion of 1-year follow-up to review laboratory assessments. Receives: Other: Usual Care |
| Metformin Therapy | Active comparator | Participants randomized to the metformin arm of the study will receive this medication from months 1 through 12 after randomization. Subjects will receive 850 mg daily for 1 month and increase to 850 mg twice daily thereafter if no side effects are experienced. Receives: Drug: Metformin Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Study tests difference in body weight (Weight in kg) between treatment conditions and usual care at 12 months.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew J O'Brien, MD, MSc, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088034
- Sponsor's protocol ID
- 21273
- Status last verified
- Nov 2020
- First submitted
- 5 Mar 2014
- Last updated
- 22 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotora-led Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
- ClinicalTrials.gov ID
- NCT02088034
- Acronym / sponsor ID
- 21273
- Conditions
- Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Posted 22 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of this project is to develop and test a behavioral intervention delivered by promotoras to help at-risk Latinas lose weight and prevent diabetes.
Detailed description
The goal of the proposed research is to compare two evidence-based strategies for preventing type 2 diabetes - promotora-led lifestyle intervention and metformin - vs. usual care (UC) among Latinas in a "real world" setting. The aims of this study are to 1) develop a protocol-based, promotora-led lifestyle intervention (PLI) to promote weight loss in at-risk Latinas, and assess its feasibility; 2) compare changes in weight and cardiometabolic markers-hemoglobin A1C, fasting lipids, blood pressure-from baseline to 1 year between at-risk Latinas randomly assigned to the PLI group versus metformin and usual care (UC) groups; and 3) understand the social and cultural context surrounding weight-related behaviors among Latinas at-risk for diabetes. The investigators hypothesize that Latinas assigned to PLI and metformin will have greater weight loss (primary outcome) and greater improvements in cardiometabolic markers from baseline to 1 year than those randomized to UC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Promotora-led Intervention | Experimental | Behavioral: Promotora-led InterventionThe Promotora-led Intervention consists of a core curriculum or 12 group sessions of 90 minute duration over a 12-week period and will be followed by a maintenance phase of 10 biweekly and then monthly 90-minute sessions during months 4 through 12. One promotora will lead each session in Spanish, exploring such topics as being active, low-fat diets, portion control, self monitoring, problem solving and life-style changes. |
| Usual care | Active comparator | Other: Usual CareOne physician visit at Puentes de Salud or Congreso Health Center to discuss healthy lifestyle behaviors that promote weight loss and diabetes prevention. During that visit, UC participants will also receive standard educational materials in Spanish from the NIDDK Weight-control Information Network covering the same topics. UC participants will receive another physician visit upon completion of 1-year follow-up to review laboratory assessments. |
| Metformin Therapy | Active comparator | Drug: Metformin TherapyParticipants randomized to the metformin arm of the study will receive this medication from months 1 through 12 after randomization. Subjects will receive 850 mg daily for 1 month and increase to 850 mg twice daily thereafter if no side effects are experienced. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female gender
- Latino ethnicity
- Spanish fluency
- Age ≥20 years
- BMI ≥25 kg/m2
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 InterventionAlso: ILIBehavioral life-style program lead by a team of trained community health workers (called promotoras) with 2 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 |
| Metformin TherapyAlso: MetforminParticipants in this group will receive metformin 850 mg bid for one year. | Drug | Metformin Therapy |
| Usual CareAlso: ControlParticipants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials. | Other | Usual care |
Primary outcome
Body Weight
Time frame: 1 year
Study tests difference in body weight (Weight in kg) between treatment conditions and usual care at 12 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Promotora-led Intervention and Metformin Therapy in people with Diabetes, run by Temple 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 6 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 22 Dec 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 1 year). 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 22 Dec 2020.