Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
NCT ID: NCT06948825
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-10-27
2026-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Is a Lifestyle Intervention or Metformin more effective for weight loss in postpartum women with recent gestational diabetes?
Researchers will compare a 6-month Lifestyle Intervention and Metformin to see if either intervention is more effective in achieving weight loss and improving health outcomes.
Participants will:
* Attend an in-person baseline visit to receive a Bluetooth-enabled scale and Fitbit, have blood drawn for testing, and have their height, weight, and blood pressure measured. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length.
* Track diet, physical activity, and weight using the Fitbit and Looseit! apps.
* Attend weekly online group sessions for the first 4 weeks, then biweekly sessions.
* If not meeting weight loss goals, be randomized to either Enhanced Lifestyle Intervention or Metformin arms of the study.
* If randomized to Metformin, participants will attend one in-person meeting with the study provider, get blood drawn for testing, and undergo a urine pregnancy test before starting the medication.
* Continue with biweekly group sessions or have regular check-in calls.
* If randomized to the Enhanced Lifestyle Intervention, participants will get a free Instacart membership, a 1:1 session with the study health counselor focused on meal planning and free grocery delivery once a week for the remainder of the study.
* Participants will meet every other week via Zoom with the health counselor and other participants in the enhanced lifestyle arm.
* At the end of the 6 months, all participants will come for an in-person visit to get blood drawn for testing. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals
NCT06445270
A Pragmatic Approach to Lower Diabetes Risk After Gestational Diabetes
NCT05280496
Diabetes Prevention Strategies in Women With Gestational Diabetes Mellitus (GDM)
NCT01344278
Lifestyle Intervention Program for Women With Gestational Diabetes or Gestational Impaired Glucose Tolerance
NCT01489163
Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes
NCT00835861
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Baseline: Participants will come for an in-person visit to the GW School of Public Health and receive a Bluetooth-enabled digital scale and a Fitbit activity tracker. Research staff will help participants set up a study Fitbit and Looseit! account. Participants will undergo serum blood collection (10 ml) for HgbA1c and lipids. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length. Participants will be asked to use this Fitbit and Looseit! account for the duration of the study to track their diet, activity, and weight. Study staff will access this data, review participant progress, and provide feedback as needed.
Start: All participants will begin with the DPP-based Lifestyle Intervention (LI). The program includes weekly online 45-minute Zoom group sessions for 4 weeks. After week 4, Zoom group sessions will be biweekly. The goal is a 2% weight loss at 4 weeks and a 3% weight loss at 6 weeks. These sessions will be led by a trained health counselor who is part of the research team. The health counselor will review the Fitbit Tracker information and provide tips for improving dietary intake and physical activity via email or text messaging based on the participant's preference.
At the end of week 4 and week 6, participants will submit their weight through Bluetooth-enabled scales.
If they have reached their weight loss goal, they will continue with the lifestyle intervention (LI) with online Zoom group sessions held every other week for the remainder of the intervention (for a total of a 6-month intervention).
After 4 or 6 weeks, participants who have not yet reached their weight loss goal (non-responders) will be randomly assigned to one of two intervention groups:
1. DPP-based Enhanced Lifestyle intervention (eLI)
OR
2. Metformin (850 mg daily x 7 days, then 850 mg twice daily) orally
Enhanced Lifestyle Intervention (eLI): Participants will continue with the same components as the Lifestyle Intervention (LI), with the addition of guidance on healthy meal planning and online grocery shopping, including one free delivery per week. If randomized to this group, participants will continue to have group sessions every other week with others in the eLI arm of the study for the duration of the study (5 or 4.5 months, depending on when they were randomized to the Metformin arm) for a total of a 6-month intervention. Group sessions will last 45-60 minutes each. These sessions will be led by a trained health counselor in the research team. The health counselor will review the Fitbit Tracker and looseit! information and provide tips for improving dietary intake and physical activity via email or text messaging based on the participant's preference.
Metformin Arm: Participants in this arm will have an individual in-person session with the health counselor and study provider where they receive information about 1) the risks and benefits of Metformin for weight loss, 2) potential risks of infant hypoglycemia and the signs/symptoms of infant hypoglycemia, 3) risk factors for development of infant hypoglycemia and the potential long-term effects and consequences of infant hypoglycemia and, 4) guidance on how to take Metformin. After the in-person session, participants will visit the LabCorp facility on the GW Foggy Bottom campus to provide 5 mL of serum for creatinine and liver function testing, as well as undergo a urine pregnancy test. Participants with abnormal liver function tests (ALT outside 4-36 U/L or AST outside 8-33 U/L), eGFR \< 60 ml/min, or a positive pregnancy test will be ineligible for Metformin. Once lab results are reviewed, participants will be placed on Metformin by mouth (850 mg daily x 7 days, then 850 mg twice daily). Tablets will be distributed by the Investigational Drug Pharmacy at the George Washington School of Medicine and Health Sciences. This is the current dosage prescribed for weight loss in the clinical setting.
Participants on Metformin will have a 15-minute follow-up call one week after starting the medication to answer additional questions, assess for any medication side effects, and assess for adherence, and then 15-minute follow-up calls by the research team every 2 weeks. Participants will be educated that it is safe to continue to breastfeed while on Metformin, as recommended by the American College of Obstetricians and Gynecologists published recommendations on postpartum care following a pregnancy with GDM. There are no group sessions for this group. Participants will be encouraged to continue practicing healthy lifestyle behaviors learned during the first 4 weeks of the intervention.
End of study: At the end of the study (6 months), participants will complete one questionnaire with updates about their health since their baseline questionnaire and will also complete 9 online questionnaires (same as baseline). Participants will come for an in-person visit where they will be asked to bring their pill container, if they were randomized to the Metformin arm, and provide a 10 ml serum sample for HbA1c, and lipids via LabCorp. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Enhanced Lifestyle (eLI)
Participants will continue with the same components as the Lifestyle Intervention (LI), with the addition of guidance on healthy meal planning and online grocery shopping, including one free delivery per week via instacart. If randomized to this group, participants will continue to have group sessions every other week with others in the eLI arm of the study for the duration of the study (5 or 4.5 months depending on when they were randomized to the Metformin arm) for a total of a 6-month intervention. Group sessions will last 45-60 minutes each. These sessions will be led by a trained health counselor.
Enhanced Lifestyle Intervention
Participants in the Enhanced Lifestyle Intervention will meet every other week, and will get a free instacart membership to have access to free grocery delivery. Additionally, participants in this intervention will have a 1:1 virtual meeting focused on meal planning with the study health counselor.
Metformin arm (MI)
Participants in this arm will have an individual in-person session with the health counselor and study provider where they receive information about 1) the risks and benefits of Metformin for weight loss, 2) potential risks of infant hypoglycemia and the signs/symptoms of infant hypoglycemia, 3) risk factors for development of infant hypoglycemia and the potential long-term effects and consequences of infant hypoglycemia and, 4) guidance on how to take Metformin.
Participants will be placed on Metformin by mouth (850 mg daily x 7 days, then 850 mg twice daily) and will have a 15-minute follow-up call one week after starting the medication to answer additional questions, assess for any medication side effects, and assess for adherence, and then 15-minute follow-up calls by the research team every 2 weeks. Participants will be encouraged to continue practicing healthy lifestyle behaviors learned during the first 4 weeks of the intervention.
Metformin Hcl 850Mg Tab
Participants randomized to Metformin will have a prescription of Metformin 850mg orally twice a day. The participant will get blood drawn for testing, undergo a urine pregnancy test, and meet with the study provider to discuss the medication.
Lifestyle Intervention (LI)
All participants will begin with the DPP-based Lifestyle Intervention (LI). This arm includes weekly online 45-minute Zoom group sessions for 4 weeks. After week 4, Zoom group sessions will be biweekly. The goal is a 2% weight loss at 4 weeks and a 3% weight loss at 6 weeks. If participants reach their weight loss goal, they will continue in this arm of the study. These sessions will be led by a trained health counselor.
Lifestyle Intervention
Participants in the Lifestyle Intervention will meet once a week via zoom with the study health counselor to go over lesson plans. After 4 weeks, participants will meet via zoom every other week.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Metformin Hcl 850Mg Tab
Participants randomized to Metformin will have a prescription of Metformin 850mg orally twice a day. The participant will get blood drawn for testing, undergo a urine pregnancy test, and meet with the study provider to discuss the medication.
Lifestyle Intervention
Participants in the Lifestyle Intervention will meet once a week via zoom with the study health counselor to go over lesson plans. After 4 weeks, participants will meet via zoom every other week.
Enhanced Lifestyle Intervention
Participants in the Enhanced Lifestyle Intervention will meet every other week, and will get a free instacart membership to have access to free grocery delivery. Additionally, participants in this intervention will have a 1:1 virtual meeting focused on meal planning with the study health counselor.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI of 25 kg/m2 to 45 kg/m2
* Singleton delivery
* Participants must also have a working cell phone, be willing to accept email or text messages attend Zoom calls, and be willing to be potentially randomized to drug therapy with Metformin.
Exclusion Criteria
* Participation in any other weight loss program or taking weight loss medication.
* Normal or underweight BMI (BMI \< 24.9 kg/m2)
* Multi-fetal (twins or triplets) gestation
* Women with type 1 or type 2 diabetes, malignancy, other serious co-morbidities (advanced kidney disease, NYHA class 3-4 CHF, advanced COPD), schizophrenia or other major psychiatric disease, and substance abuse or AIDS.
* Women whose infants have significant medical conditions, such as congenital heart disease, renal impairment, or hepatic impairment.
18 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
George Washington University
OTHER
University of North Carolina
OTHER
Diabetes Sisters
UNKNOWN
American Diabetes Association
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wanda Nicholson, MD
Role: PRINCIPAL_INVESTIGATOR
The George Washington University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Milken Institute School of Public Health - The George Washington University
Washington D.C., District of Columbia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Ferrara A. Increasing prevalence of gestational diabetes mellitus: a public health perspective. Diabetes Care. 2007 Jul;30 Suppl 2:S141-6. doi: 10.2337/dc07-s206. No abstract available.
DeSisto CL, Kim SY, Sharma AJ. Prevalence estimates of gestational diabetes mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007-2010. Prev Chronic Dis. 2014 Jun 19;11:E104. doi: 10.5888/pcd11.130415.
HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
Heida KY, Franx A, van Rijn BB, Eijkemans MJ, Boer JM, Verschuren MW, Oudijk MA, Bots ML, van der Schouw YT. Earlier Age of Onset of Chronic Hypertension and Type 2 Diabetes Mellitus After a Hypertensive Disorder of Pregnancy or Gestational Diabetes Mellitus. Hypertension. 2015 Dec;66(6):1116-22. doi: 10.1161/HYPERTENSIONAHA.115.06005. Epub 2015 Oct 12.
Hedderson M, Ehrlich S, Sridhar S, Darbinian J, Moore S, Ferrara A. Racial/ethnic disparities in the prevalence of gestational diabetes mellitus by BMI. Diabetes Care. 2012 Jul;35(7):1492-8. doi: 10.2337/dc11-2267. Epub 2012 May 22.
Bellamy L, Casas JP, Hingorani AD, Williams D. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet. 2009 May 23;373(9677):1773-9. doi: 10.1016/S0140-6736(09)60731-5.
Hamman RF, Wing RR, Edelstein SL, Lachin JM, Bray GA, Delahanty L, Hoskin M, Kriska AM, Mayer-Davis EJ, Pi-Sunyer X, Regensteiner J, Venditti B, Wylie-Rosett J. Effect of weight loss with lifestyle intervention on risk of diabetes. Diabetes Care. 2006 Sep;29(9):2102-7. doi: 10.2337/dc06-0560.
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.
Elmer PJ, Grimm R Jr, Laing B, Grandits G, Svendsen K, Van Heel N, Betz E, Raines J, Link M, Stamler J, et al. Lifestyle intervention: results of the Treatment of Mild Hypertension Study (TOMHS). Prev Med. 1995 Jul;24(4):378-88. doi: 10.1006/pmed.1995.1062.
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.
Whelton PK, Appel LJ, Espeland MA, Applegate WB, Ettinger WH Jr, Kostis JB, Kumanyika S, Lacy CR, Johnson KC, Folmar S, Cutler JA. Sodium reduction and weight loss in the treatment of hypertension in older persons: a randomized controlled trial of nonpharmacologic interventions in the elderly (TONE). TONE Collaborative Research Group. JAMA. 1998 Mar 18;279(11):839-46. doi: 10.1001/jama.279.11.839.
Cassina M, Dona M, Di Gianantonio E, Litta P, Clementi M. First-trimester exposure to metformin and risk of birth defects: a systematic review and meta-analysis. Hum Reprod Update. 2014 Sep-Oct;20(5):656-69. doi: 10.1093/humupd/dmu022. Epub 2014 May 25.
Ali MK, Echouffo-Tcheugui J, Williamson DF. How effective were lifestyle interventions in real-world settings that were modeled on the Diabetes Prevention Program? Health Aff (Millwood). 2012 Jan;31(1):67-75. doi: 10.1377/hlthaff.2011.1009.
Phelan S, Hagobian T, Brannen A, Hatley KE, Schaffner A, Munoz-Christian K, Tate DF. Effect of an Internet-Based Program on Weight Loss for Low-Income Postpartum Women: A Randomized Clinical Trial. JAMA. 2017 Jun 20;317(23):2381-2391. doi: 10.1001/jama.2017.7119.
Castorino K, Jovanovic L. Pregnancy and diabetes management: advances and controversies. Clin Chem. 2011 Feb;57(2):221-30. doi: 10.1373/clinchem.2010.155382. Epub 2010 Dec 9.
Syngelaki A, Nicolaides KH, Balani J, Hyer S, Akolekar R, Kotecha R, Pastides A, Shehata H. Metformin versus Placebo in Obese Pregnant Women without Diabetes Mellitus. N Engl J Med. 2016 Feb 4;374(5):434-43. doi: 10.1056/NEJMoa1509819.
American College of Obstetricians and Gynecologists Committee on Practice Bulletins--Obstetrics. ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 30, September 2001 (replaces Technical Bulletin Number 200, December 1994). Gestational diabetes. Obstet Gynecol. 2001 Sep;98(3):525-38.
ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
ACOG Committee Opinion No. 435: postpartum screening for abnormal glucose tolerance in women who had gestational diabetes mellitus. Obstet Gynecol. 2009 Jun;113(6):1419-1421. doi: 10.1097/AOG.0b013e3181ac06b6.
Nicholson 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.
Refuerzo JS, Viteri OA, Hutchinson M, Pedroza C, Blackwell SC, Tyson JE, Ramin SM. The effects of metformin on weight loss in women with gestational diabetes: a pilot randomized, placebo-controlled trial. Am J Obstet Gynecol. 2015 Mar;212(3):389.e1-9. doi: 10.1016/j.ajog.2014.12.019. Epub 2014 Dec 16.
Hale TW, Kristensen JH, Hackett LP, Kohan R, Ilett KF. Transfer of metformin into human milk. Diabetologia. 2002 Nov;45(11):1509-14. doi: 10.1007/s00125-002-0939-x. Epub 2002 Sep 25.
Gardiner SJ, Kirkpatrick CM, Begg EJ, Zhang M, Moore MP, Saville DJ. Transfer of metformin into human milk. Clin Pharmacol Ther. 2003 Jan;73(1):71-7. doi: 10.1067/mcp.2003.9.
Briggs GG, Ambrose PJ, Nageotte MP, Padilla G, Wan S. Excretion of metformin into breast milk and the effect on nursing infants. Obstet Gynecol. 2005 Jun;105(6):1437-41. doi: 10.1097/01.AOG.0000163249.65810.5b.
Related Links
Access external resources that provide additional context or updates about the study.
ACOG Statement on AMA Support for 12 Months of Postpartum Coverage Under Medicaid
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
48359-1-ECNS91615N
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.