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Gestational DiabetesNCT01344278

Diabetes Prevention Strategies in Women With Gestational Diabetes Mellitus (GDM)

A study testing Lifestyle Counseling in people with Gestational Diabetes and Obesity, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main goal of this study is to examine the comparative effectiveness of diabetes prevention strategies in women with Gestational Diabetes Mellitus (GDM) on the control of the following conditions: obesity, hyperglycemia, hypertension and depression. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Gestational Diabetes, Obesity
What is being tested?
Lifestyle Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,480 participants
Where
1 siteUnited States
Study dates
Apr 2011to Sep 2015
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All women, 18 years of age or older, receiving medical care at Kaiser Permanente Northern California with a pregnancy complicated by gestational diabetes between March 2011 and May 2012 that have a telephone or cellular phone will be eligible.

Who cannot join

  • Women with overt diabetes not recognized prior to pregnancy (any women with fasting plasma glucose > 126 mg/dl, or any plasma glucose level over 200 mg/dl on more than 1 occasion during pregnancy) will be excluded from the analyses but will be eligible for the lifestyle intervention.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Division of Research Northern California

    Oakland, California, 94612

Other trials in United States

About this study

Official title: Comparative Effectiveness of Diabetes Prevention Strategies in Women With GDM

The main goal of this study is to examine the comparative effectiveness of diabetes prevention strategies in women with Gestational Diabetes Mellitus (GDM) on the control of the following conditions: obesity, hyperglycemia, hypertension and depression. This randomized lifestyle intervention study will be conducted at Kaiser Permanente Northern California. Women in the intervention will receive a letter on gestational weight gain during pregnancy and in the postpartum period, a curriculum of individualized lifestyle counseling via telephone, augmented with e-mail and an interactive Web site. Patients randomized to the usual care arm will receive the standard-care telephone calls from the Perinatal Center during pregnancy and the Center's printed educational materials postpartum. Outcomes will be assessed through the electronic medical record and patient surveys conducted during pregnancy and at 6-weeks, 6- months and 1-year postpartum.

Being tested
Lifestyle Counseling
Medical subject headings
Diabetes, Gestational, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle CounselingBehavioural

    A lifestyle curriculum of individualized telephone counseling calls, augmented with e-mails and an interactive study Web site.

Study groups in NCT01344278
Study groupRoleWhat they receive
Lifestyle CounselingExperimentalNot described
Receives: Behavioral: Lifestyle Counseling
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary outcome: meeting the postpartum weight goal

    Will be the proportion of women who reach their postpartum weight goal (based on their pre-pregnancy weight) and the total amount of weight change (in kilograms).

    Weight goals:

    1. reaching pre-pregnancy weight if women had a normal pre-pregnancy weight; or b) achieving a 5% reduction from pre-pregnancy weight if overweight or obese prior to pregnancy.

    Measured: through 12 months postpartum

Secondary outcomes (5)

  1. Blood pressure

    Measured: through 12 months postpartum

  2. Depression

    Measured: through 12 months postpartum

  3. Glycemia

    Measured: through 12 months postpartum

  4. percent of calories from fat

    Measured: through 12 months postpartum

  5. physical activity

    Measured: through 12 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionDec 2013
  4. Study completionSep 2015

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
2,480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01344278
Sponsor's protocol ID
R01HS019367-01
Status last verified
Apr 2016
First submitted
27 Apr 2011
Last updated
25 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Gadgil MD, Ehrlich SF, Zhu Y, Brown SD, Hedderson MM, Crites Y, Ferrara A. Dietary Quality and Glycemic Control Among Women with Gestational Diabetes Mellitus. J Womens Health (Larchmt). 2019 Feb;28(2):178-184. doi: 10.1089/jwh.2017.6788. Epub 2018 Oct 30.

    PubMed 30376391

  • Hedderson MM, Brown SD, Ehrlich SF, Tsai AL, Zhu Y, Quesenberry CP, Crites Y, Ferrara A. A Tailored Letter Based on Electronic Health Record Data Improves Gestational Weight Gain Among Women With Gestational Diabetes Mellitus: The Gestational Diabetes' Effects on Moms (GEM) Cluster-Randomized Controlled Trial. Diabetes Care. 2018 Jul;41(7):1370-1377. doi: 10.2337/dc17-1133. Epub 2018 Apr 18.

    PubMed 29669736

  • Ferrara A, Hedderson MM, Brown SD, Albright CL, Ehrlich SF, Tsai AL, Caan BJ, Sternfeld B, Gordon NP, Schmittdiel JA, Gunderson EP, Mevi AA, Herman WH, Ching J, Crites Y, Quesenberry CP Jr. The Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women With Gestational Diabetes Mellitus: The Gestational Diabetes' Effects on Moms (GEM) Cluster Randomized Controlled Trial. Diabetes Care. 2016 Jan;39(1):65-74. doi: 10.2337/dc15-1254. Epub 2015 Dec 9.

    PubMed 26657945

  • Ferrara A, Hedderson MM, Albright CL, Brown SD, Ehrlich SF, Caan BJ, Sternfeld B, Gordon NP, Schmittdiel JA, Gunderson EP, Mevi AA, Tsai AL, Ching J, Crites Y, Quesenberry CP Jr. A pragmatic cluster randomized clinical trial of diabetes prevention strategies for women with gestational diabetes: design and rationale of the Gestational Diabetes' Effects on Moms (GEM) study. BMC Pregnancy Childbirth. 2014 Jan 15;14:21. doi: 10.1186/1471-2393-14-21.

    PubMed 24423410

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle Counseling in people with Gestational Diabetes and Obesity, run by Kaiser Permanente 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 1 inclusion and 1 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 25 Apr 2016. 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?

Primary outcome: meeting the postpartum weight goal (time frame: through 12 months postpartum). 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 NCT01344278, which also lists 4 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 25 Apr 2016.

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