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Gestational Diabetes MellitusPhase 2DEBINCT00460018

Diet, Exercise, and Breastfeeding Intervention Program for Women With Gestational Diabetes (DEBI Trial)

A Phase 2 study testing Diet, Exercise, and Breastfeeding Intervention in people with Gestational Diabetes Mellitus, run by Kaiser Permanente at 5 sites 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 primary aim of this study is to evaluate whether a lifestyle intervention of diet, exercise, and breastfeeding is associated with decreased postpartum weight retention and reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with gestational diabetes mellitus (GDM). Read more about this study

Who is it for?
Ages 20 to 45 years, women only
Conditions the study is for
Gestational Diabetes Mellitus
What is being tested?
Diet, Exercise, and Breastfeeding Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
5 sitesUnited States
Study dates
Sep 2005to not given
Phase
Phase 2
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 20 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Diagnosis of Gestational Diabetes Mellitus

Who cannot join

  • Ever diagnosed with diabetes when not pregnant
  • Ever diagnosed with cardiovascular disease
  • Ever diagnosed with lung disease
  • Hemoglobin < 9.5 mg/dl
  • Hematocrit less than 30%
  • SBP >= 140 or DBP >= 90 in the last month
  • Diagnosis of thyroid disease in the last month

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Kaiser Permanente Oakland

    Oakland, California, 94611

  • Kaiser Permanente Division of Research

    Oakland, California, 94612

  • Kaiser Permanente San Francisco

    San Francisco, California, 94115

  • Kaiser Permanente Santa Clara/Santa Teresa

    Santa Clara, California, 95051

  • Kaiser Permanente Walnut Creek

    Walnut Creek, California, 94596

Other trials in United States

About this study

Official title: Diet, Exercise and Breastfeeding Intervention (DEBI) Program for Women With Gestational Diabetes

The primary aim of this study is to evaluate whether a lifestyle intervention of diet, exercise, and breastfeeding is associated with decreased postpartum weight retention and reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with gestational diabetes mellitus (GDM). Secondary outcomes are postpartum levels of plasma insulin, markers of insulin resistance, adiponectin, dietary fat, physical activity, and breastfeeding duration.

Read the detailed description

Postpartum predictors of type 2 diabetes incidence in women with GDM are pregnancy weight retention and postpartum weight gain. By promoting physical activity and appropriate diet during pregnancy and soon after delivery, and preventing excessive pregnancy weight gain and postpartum weight retention, the postpartum incidence of obesity and type 2 diabetes might be reduced or delayed in GDM women. We are implementing and evaluating a lifestyle intervention of diet, physical activity, and breastfeeding among women with GDM. The diet and physical activity elements of the intervention are similar to the DPP-Follow-up study. All participants have GDM by plasma glucose levels measured during a standard 100-g, 3-h OGTT according to the ADA and the ACOG criteria and have no contraindications to participating in a diet and physical activity program. At study entry, eligible women are randomly assigned to life-style intervention or usual medical care. The intervention starts during pregnancy and continues for one year postpartum. It consists of structured, individually tailored, in-person sessions and telephone calls with a lactation consultant and a life-style coach. The goals of the intervention during pregnancy are to help GDM women comply with the Institute of Medicine guidelines for weight gain by following the ADA and ACOG recommendations for physical activity and diet. After pregnancy, the goals of the intervention are to help women exclusively breastfeed for at least six months and reach their pre-pregnancy weight. For those women who were overweight or obese prior to pregnancy, the additional goal of a reduction in weight of at least 5% of their pre-pregnancy weight is also set. For the maintenance phase of the intervention, beginning at 8 months postpartum, the intervention women receive tailored written materials in the mail and telephone calls reinforcing the positive changes they have adopted. All participants have follow-up clinic visits at 8-week, 8-month, 12-month, 18-month, and 24-month after delivery. Data analyses will be by intent-to-treat. Demographics, psychosocial and behavioral factors that may be related to success at achieving the postpartum weight goals and the secondary postpartum outcomes will be examined.

Being tested
Diet, Exercise, and Breastfeeding Intervention
Keywords
Gestational Diabetes Mellitus, Weight Loss, Physical Activity, Breastfeeding, Pregnancy, Postpartum, Intervention, Prevention
Medical subject headings
Diabetes, Gestational, Weight Loss, Motor Activity, Breast Feeding

What participants receive

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

  • Diet, Exercise, and Breastfeeding InterventionBehavioural

    Also called Intervention

    Phase I (Pregnancy Program from GDM diagnosis to delivery): One in-person session with the lifestyle coach, two phone calls with the lifestyle coach, and one in-person session with the lactation consultant

    Phase II (Early Post-partum Period from delivery to 6 weeks post-partum): Two to four routine phone calls with the lactation consultant

    Phase III (Late Post-partum Period 6 weeks to 7 months postpartum): Two in-person sessions with the lifestyle coach, up to 11 phone calls with the lifestyle coach, and two to three routine calls with the lactation consultant

    Phase IV (Maintenance Phase 8 months to 1 year postpartum): One newsletter from the lifestyle coaches, two recipe letters and continue calls with the lifestyle coach (optional)

Study groups in NCT00460018
Study groupRoleWhat they receive
InterventionExperimentalWomen receiving the DEBI Intervention
Receives: Behavioral: Diet, Exercise, and Breastfeeding Intervention
No interventionNo interventionWomen receiving standard care

What is being measured

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

  1. Postpartum weight retention

    Measured: no more than 1.5 years

Secondary outcomes (7)

  1. reduced plasma glucose levels (measured at 6 weeks and 1 year postpartum)

    Measured: 1 year

  2. levels of plasma insulin

    Measured: 1 year

  3. markers of insulin resistance

    Measured: 1 year

  4. adiponectin

    Measured: 1 year

  5. dietary fat

    Measured: no more than 1.5 years

  6. physical activity

    Measured: no more than 1.5 years

  7. breastfeeding duration

    Measured: no more than 1.5 years

Timeline

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

  1. First posted13 Apr 2007 (estimated)
  2. Study startSep 2005

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00460018
Sponsor's protocol ID
CN-04AFerr-04-H
Other IDs
CN-03AFerr-02
Acronym
DEBI
Status last verified
Jan 2009
First submitted
11 Apr 2007
Last updated
19 Jun 2009
Results posted
No
Data monitoring committee
No

Publications

  • Metzger BE. Summary and recommendations of the Third International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes. 1991 Dec;40 Suppl 2:197-201. doi: 10.2337/diab.40.2.s197. No abstract available.

    PubMed 1748259

  • Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.

    PubMed 11333990

  • Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

    PubMed 11832527

  • O'Toole ML, Sawicki MA, Artal R. Structured diet and physical activity prevent postpartum weight retention. J Womens Health (Larchmt). 2003 Dec;12(10):991-8. doi: 10.1089/154099903322643910.

    PubMed 14709187

  • Leermakers EA, Anglin K, Wing RR. Reducing postpartum weight retention through a correspondence intervention. Int J Obes Relat Metab Disord. 1998 Nov;22(11):1103-9. doi: 10.1038/sj.ijo.0800734.

    PubMed 9822949

  • Ferrara A, Hedderson MM, Albright CL, Ehrlich SF, Quesenberry CP Jr, Peng T, Feng J, Ching J, Crites Y. A pregnancy and postpartum lifestyle intervention in women with gestational diabetes mellitus reduces diabetes risk factors: a feasibility randomized control trial. Diabetes Care. 2011 Jul;34(7):1519-25. doi: 10.2337/dc10-2221. Epub 2011 May 3.

    PubMed 21540430

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Diet, Exercise, and Breastfeeding Intervention in people with Gestational Diabetes Mellitus, run by Kaiser Permanente at 5 sites 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 7 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 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Postpartum weight retention (time frame: no more than 1.5 years). 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 NCT00460018, which also lists 6 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 19 Jun 2009.

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