Gestational Diabetes MellitusNCT01600534
GooDMoMS: A Multimodel Pregnancy and Postpartum Intervention for Gestational Diabetics
A study testing lifestyle counseling in people with Gestational Diabetes Mellitus and Pregnancy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study includes a behavioral educational intervention that focuses on healthy eating and physical activity during pregnancy and the postpartum among women newly diagnosed with gestational diabetes mellitus (GDM). Read more about this study
- Who is it for?
- Ages 21 to 35 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus, Pregnancy
- What is being tested?
- lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Mar 2014
- 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 21 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with gestational diabetes
- Planning to delivery with the study area
Who cannot join
- Pre-existing diabetes (type 1 or type 2 diabetes)
- Non-English speaking
- Not planning to delivery in the study area
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina clinics
Chapel Hill, North Carolina, 27599
About this study
Official title: GooDMomS: A Multimodel Pregnancy and Postpartum Intervention for Gestational Diabetics
This study includes a behavioral educational intervention that focuses on healthy eating and physical activity during pregnancy and the postpartum among women newly diagnosed with gestational diabetes mellitus (GDM).
Read the detailed description
This is a pilot trial in which 30 women newly diagnosed with gestational diabetes are randomized to either one of two groups: 1) active internet intervention or 2) self-directed educational intervention. The primary pregnancy outcome is change in A1C. The primary postpartum outcome is weight.
- Conditions
- Gestational Diabetes Mellitus, Pregnancy
- Being tested
- lifestyle counseling
- Keywords
- gestational diabetes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle counselingBehavioural
Also called healthy lifestyle, glucose control
Participants receive lifestyle counseling on healthy eating and physical activity through an internet-based program or self-directed educational program.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Participants obtain access to an internet-based educational intervention. Receives: Behavioral: lifestyle counseling |
| Usual Care Lifestyle counseling | Other | Self directed educational intervention Receives: Behavioral: lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycosylated hemoglobin
Measured: Baseline and 36 weeks gestation
Secondary outcomes (1)
Change in weight after pregnancy
Measured: 6 weeks postpartum to 24 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wanda Nicholson, MD MPH MBA, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600534
- Sponsor's protocol ID
- 12-0810
- Status last verified
- Sep 2014
- First submitted
- 15 May 2012
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Setse R, Grogan R, Cooper LA, Strobino D, Powe NR, Nicholson W. Weight loss programs for urban-based, postpartum African-American women: perceived barriers and preferred components. Matern Child Health J. 2008 Jan;12(1):119-27. doi: 10.1007/s10995-007-0211-6. Epub 2007 Jun 7.
PubMed 17554614Nicholson WK, Beckham AJ, Hatley K, Diamond M, Johnson LS, Green SL, Tate D. The Gestational Diabetes Management System (GooDMomS): development, feasibility and lessons learned from a patient-informed, web-based pregnancy and postpartum lifestyle intervention. BMC Pregnancy Childbirth. 2016 Sep 21;16(1):277. doi: 10.1186/s12884-016-1064-z.
PubMed 27654119
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GooDMomS: A Multimodel Pregnancy and Postpartum Intervention for Gestational Diabetics
- ClinicalTrials.gov ID
- NCT01600534
- Acronym / sponsor ID
- 12-0810
- Conditions
- Gestational Diabetes Mellitus, Pregnancy
- Keywords
- gestational diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 May 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.
This study includes a behavioral educational intervention that focuses on healthy eating and physical activity during pregnancy and the postpartum among women newly diagnosed with gestational diabetes mellitus (GDM).
Detailed description
This is a pilot trial in which 30 women newly diagnosed with gestational diabetes are randomized to either one of two groups: 1) active internet intervention or 2) self-directed educational intervention. The primary pregnancy outcome is change in A1C. The primary postpartum outcome is weight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: lifestyle counselingParticipants obtain access to an internet-based educational intervention. |
| Usual Care Lifestyle counseling | Other | Behavioral: lifestyle counselingSelf directed educational intervention |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with gestational diabetes
- Planning to delivery with the study area
Key exclusion criteria (3 listed)
- Pre-existing diabetes (type 1 or type 2 diabetes)
- Non-English speaking
- Not planning to delivery in the study area
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 |
|---|---|---|
| lifestyle counselingAlso: healthy lifestyle, glucose controlParticipants receive lifestyle counseling on healthy eating and physical activity through an internet-based program or self-directed educational program. | Behavioural | Lifestyle counseling, Usual Care Lifestyle counseling |
Primary outcome
Change in glycosylated hemoglobin
Time frame: Baseline and 36 weeks gestation
1 secondary outcome
Change in weight after pregnancy
Time frame: 6 weeks postpartum to 24 weeks postpartum
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 12 Sep 2014.
- Background: PubMed 17554614Setse R, Grogan R, Cooper LA, Strobino D, Powe NR, Nicholson W. Weight loss programs for urban-based, postpartum African-American women: perceived barriers and preferred components. Matern Child Health J. 2008 Jan;12(1):119-27. doi: 10.1007/s10995-007-0211-6. Epub 2007 Jun 7.
- Derived from this study: PubMed 27654119Nicholson WK, Beckham AJ, Hatley K, Diamond M, Johnson LS, Green SL, Tate D. The Gestational Diabetes Management System (GooDMomS): development, feasibility and lessons learned from a patient-informed, web-based pregnancy and postpartum lifestyle intervention. BMC Pregnancy Childbirth. 2016 Sep 21;16(1):277. doi: 10.1186/s12884-016-1064-z.
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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.
Wanda Nicholson, MD MPH MBA principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle counseling in people with Gestational Diabetes Mellitus and Pregnancy, run by University of North Carolina, Chapel Hill 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 2 inclusion and 3 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 12 Sep 2014. 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?
Change in glycosylated hemoglobin (time frame: Baseline and 36 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01600534, which also lists 2 linked publications.
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 12 Sep 2014.