Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes

NCT06948825 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 48359-1-ECNS91615N
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of a 6-month lifestyle intervention compared to Metformin in postpartum women who have delivered a singleton, live born infant within the last 12 weeks to 1 year and had a pregnancy complicated by gestational diabetes. The main question this study aims to answer is: 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.

Conditions

Weight Loss; Gestational Diabetes Mellitus in Pregnancy; Postpartum Care

Keywords

diabetes prevention; gestational diabetes; lifestyle intervention

Outcome Measures

Primary Outcomes (1)

• Mean weight change at 6 months

  Weight in kg.

  6 months

Secondary Outcomes (11)

• Change in physical activity

  6 months

• Change in blood pressure

  6 months

• Change in A1c

  6 months

• Change in lipids

  6 months

• Change in quality of life

  6 months

Study Arms (3)

Enhanced Lifestyle (eLI)

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Lifestyle Intervention

Metformin arm (MI)

ACTIVE COMPARATOR

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.

Drug: Metformin Hcl 850Mg Tab

Lifestyle Intervention (LI)

ACTIVE COMPARATOR

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.

Behavioral: Lifestyle Intervention

Interventions

Metformin Hcl 850Mg Tab DRUG

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.

Metformin arm (MI)

Lifestyle Intervention BEHAVIORAL

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.

Lifestyle Intervention (LI)

Enhanced Lifestyle Intervention BEHAVIORAL

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.

Enhanced Lifestyle (eLI)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Mothers between 8 weeks and 12 months postpartum from a pregnancy complicated by GDM will be recruited. The research team will begin recruiting women who are at least 8 weeks postpartum to provide time to describe the study and answer any questions. Mothers who want to participate will be enrolled in the study between 12 weeks and 12 months postpartum.
• 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.

You may not qualify if:

• Pregnant or planned pregnancy within the next 6 months.
• 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.

Sponsors & Collaborators

• George Washington University: lead
• University of North Carolina: collaborator
• Diabetes Sisters: collaborator
• American Diabetes Association: collaborator

Study Sites (1)

Milken Institute School of Public Health - The George Washington University

Washington D.C., District of Columbia, 20052, United States

RECRUITING

Related Publications (24)

• 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.

  PMID: 17596462 BACKGROUND

• 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.

  PMID: 24945238 BACKGROUND

• 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.

  PMID: 18463375 BACKGROUND

• 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.

  PMID: 26459420 BACKGROUND

• 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.

  PMID: 22619080 BACKGROUND

• 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.

  PMID: 19465232 BACKGROUND

• 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.

  PMID: 16936160 BACKGROUND

• 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.

  PMID: 11832527 BACKGROUND

• 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.

  PMID: 7479629 BACKGROUND

• 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.

  PMID: 11333990 BACKGROUND

• 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.

  PMID: 9515998 BACKGROUND

• 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.

  PMID: 24861556 BACKGROUND

• 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.

  PMID: 22232096 BACKGROUND

• 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.

  PMID: 28632867 BACKGROUND

• 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.

  PMID: 21148303 BACKGROUND

• 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.

  PMID: 26840133 BACKGROUND

• 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.

  PMID: 11547793 BACKGROUND

• ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.

  PMID: 29683911 BACKGROUND

• 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.

  PMID: 19461459 BACKGROUND

• 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.

  PMID: 27654119 BACKGROUND

• 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.

  PMID: 25526875 BACKGROUND

• 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.

  PMID: 12436333 BACKGROUND

• 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.

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• 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.

  PMID: 15932841 BACKGROUND

Related Links

• ACOG Statement on AMA Support for 12 Months of Postpartum Coverage Under Medicaid

MeSH Terms

Conditions

Weight Loss; Diabetes, Gestational

Interventions

Metformin

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Wanda Nicholson, MD

  The George Washington University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer R Gomez Berrospi, MPH

CONTACT

202-994-2582; Jengomez291@gwu.edu

Wanda Nicholson, MD

CONTACT

wanda.nicholson@email.gwu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adaptive trial design. All participants receive the basic lifestyle intervention. If they do not reach their weight loss threshold, they are then randomized to an enhanced lifestyle intervention or Metformin.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 29, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 9 months following close of the study.
• Access Criteria: Based on a formal request to the principal investigator.

Locations

US (1)