DiabetesNCT01613937
Community Approach to Reduce the Risks of Diabetes After Gestational Diabetes Mellitus
A study testing Dulce Mother lifestyle training program in people with Diabetes, run by Scripps Whittier Diabetes Institute.
Trial summary
Objective: The current study examined the effectiveness of a culturally-appropriate adaptation of the diabetes prevention program (DPP) curriculum in reducing type 2 diabetes risk in Latinas with a history of gestational diabetes mellitus (GDM). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Diabetes
- What is being tested?
- Dulce Mother lifestyle training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Sep 2013
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-45 years old
- Latina
- GDM within the last 3 years
- able and willing to participate in physical activity sessions
Who cannot join
- current diabetes
- severe illness that would preclude them from coming to the sessions
About this study
Official title: Dulce Mothers: A Community Approach to Reduce the Risks of Developing Diabetes After Gestational Diabetes
Objective: The current study examined the effectiveness of a culturally-appropriate adaptation of the diabetes prevention program (DPP) curriculum in reducing type 2 diabetes risk in Latinas with a history of gestational diabetes mellitus (GDM).
Research Design and Methods: Seventy-six Latinas aged 18-45 years with GDM in the past 3 years participated in an 8-week group-based, peer-educator led lifestyle intervention based on the DPP, with adaptations appropriate to Latino culture and recent mothers. Clinical and self-report indicators were assessed at baseline, post-intervention (month-3), and follow-up (month-6).
Hypothesis-The modified culturally tailored DPP will improve risk factors associated with the development of type 2 DM.
- Conditions
- Diabetes
- Being tested
- Dulce Mother lifestyle training program
- Keywords
- Latinas, Gestational Diabetes, Prevention
- Medical subject headings
- Diabetes Mellitus, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dulce Mother lifestyle training programBehavioural
12 once weekly culturally tailored lifestyle management sessions
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle | Experimental | 12 once weekly Lifestyle training program Receives: Behavioral: Dulce Mother lifestyle training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 6 months
Secondary outcomes (5)
weight
Measured: 6 months
lipids
Measured: 6 months
blood pressure
Measured: 6 months
composition of dietary intake at all time points
Measured: 6 months
hours of physical activity per week at all time points
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startDec 2009
- Primary completionSep 2011
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Whittier Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
- Investigators
- Athena Philis-Tsimikas, MD, Principal investigator, Scripps Whittier Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613937
- Sponsor's protocol ID
- SWDI Dulce Mothers
- Status last verified
- Nov 2014
- First submitted
- 4 Jun 2012
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dulce Mothers: A Community Approach to Reduce the Risks of Developing Diabetes After Gestational Diabetes
- ClinicalTrials.gov ID
- NCT01613937
- Acronym / sponsor ID
- SWDI Dulce Mothers
- Conditions
- Diabetes
- Keywords
- Latinas, Gestational Diabetes, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Scripps Whittier Diabetes InstituteUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Jun 2012 (estimated)
- 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.
Objective: The current study examined the effectiveness of a culturally-appropriate adaptation of the diabetes prevention program (DPP) curriculum in reducing type 2 diabetes risk in Latinas with a history of gestational diabetes mellitus (GDM).
Research Design and Methods: Seventy-six Latinas aged 18-45 years with GDM in the past 3 years participated in an 8-week group-based, peer-educator led lifestyle intervention based on the DPP, with adaptations appropriate to Latino culture and recent mothers. Clinical and self-report indicators were assessed at baseline, post-intervention (month-3), and follow-up (month-6).
Hypothesis-The modified culturally tailored DPP will improve risk factors associated with the development of type 2 DM.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle | Experimental | Behavioral: Dulce Mother lifestyle training program12 once weekly Lifestyle training program |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-45 years old
- Latina
- GDM within the last 3 years
- able and willing to participate in physical activity sessions
Key exclusion criteria (2 listed)
- current diabetes
- severe illness that would preclude them from coming to the sessions
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 |
|---|---|---|
| Dulce Mother lifestyle training program12 once weekly culturally tailored lifestyle management sessions | Behavioural | Lifestyle |
Primary outcome
HbA1c
Time frame: 6 months
5 secondary outcomes
weight
Time frame: 6 months
lipids
Time frame: 6 months
blood pressure
Time frame: 6 months
composition of dietary intake at all time points
Time frame: 6 months
hours of physical activity per week at all time points
Time frame: 6 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 19 Nov 2014.
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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.
Athena Philis-Tsimikas, MD principal investigator
Scripps Whittier Diabetes Institute
Questions about this trial
What is this clinical trial studying?
A study testing Dulce Mother lifestyle training program in people with Diabetes, run by Scripps Whittier Diabetes Institute.
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 4 inclusion and 2 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 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
HbA1c (time frame: 6 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 19 Nov 2014.