Lifestyle Intervention vs Metformin for Gestational Diabetes

(GooDMomS2 Trial)

Overseen By Jennifer R Gomez Berrospi, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: George Washington University

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Diabetes, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking weight loss medication, you cannot participate in the trial.

Is metformin safe for pregnant women with gestational diabetes?

Research shows that metformin is generally safe for pregnant women with gestational diabetes, as it has been compared to insulin and used in routine clinical practice without major safety concerns. ^{1 2 3 4 5}

How does the treatment of lifestyle intervention and metformin differ from other treatments for gestational diabetes?

The combination of lifestyle intervention and metformin for gestational diabetes is unique because it combines non-drug strategies like diet and exercise with a medication that helps control blood sugar levels. This approach can be an effective alternative to insulin, especially for women with higher body mass index (BMI), and may reduce the need for additional insulin therapy. ^{4 6 7 8 9}

What data supports the effectiveness of the treatment Enhanced Lifestyle Intervention, Lifestyle Intervention, Metformin for gestational diabetes?

Research shows that lifestyle interventions can help prevent type 2 diabetes in women with a history of gestational diabetes, although results can vary. Additionally, using metformin along with lifestyle changes has been shown to improve outcomes for women with gestational diabetes compared to lifestyle changes alone. ^{3 7 10 11 12}

Who Is on the Research Team?

Wanda Nicholson, MD

Principal Investigator

The George Washington University

Are You a Good Fit for This Trial?

This trial is for postpartum women who had a single, live birth in the last 12 weeks to 1 year and experienced gestational diabetes. They should be interested in weight loss and willing to use digital tracking tools and attend online sessions. Details about specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Singleton delivery

My BMI is between 25 and 45.

I am 8 weeks to 12 months postpartum and had gestational diabetes.

Exclusion Criteria

Pregnant or planned pregnancy within the next 6 months

Multi-fetal (twins or triplets) gestation

Women whose infants have significant medical conditions, such as congenital heart disease, renal impairment, or hepatic impairment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Participants 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.

1 day

1 visit (in-person)

Lifestyle Intervention

Participants begin with a DPP-based Lifestyle Intervention, including weekly online 45-minute Zoom group sessions for 4 weeks, then biweekly sessions. The goal is a 2% weight loss at 4 weeks and a 3% weight loss at 6 weeks.

6 months

Weekly online sessions for 4 weeks, then biweekly

Randomization and Treatment

Participants not meeting weight loss goals are randomized to either Enhanced Lifestyle Intervention or Metformin. Enhanced Lifestyle includes meal planning and grocery delivery. Metformin involves medication and follow-up calls.

4.5 to 5 months

Biweekly sessions or follow-up calls

Follow-up

Participants are monitored for safety and effectiveness after treatment. At the end of the study, participants complete questionnaires and attend an in-person visit for final assessments.

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Lifestyle Intervention
• Lifestyle Intervention
• Metformin

Trial Overview The study tests if a lifestyle intervention or Metformin is better for weight loss in these women. It includes baseline measurements, digital tracking of diet/activity, group sessions, potential randomization to enhanced interventions or Metformin, with follow-up visits including infant measurements.

How Is the Trial Designed?

Group I: Enhanced Lifestyle (eLI) Active Control 1 Intervention

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.

Group II: Metformin arm (MI) Active Control 1 Intervention

Participants in this arm will have an individual in-person session with the study provider where they will receive information about 1) the risks and benefits of Metformin, 2) instructions on how to obtain Metformin from the Investigational Drug Pharmacy at the George Washington School of Medicine and Health Sciences. 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.

Group III: Lifestyle Intervention (LI) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Diabetes Sisters

Collaborator

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

Published Research Related to This Trial

Women with gestational diabetes who successfully managed their condition through lifestyle modifications were generally younger and had a lower pre-pregnancy body mass index compared to those who required medication, suggesting that these factors may influence glycemic control outcomes.

The study identified specific diagnostic parameters, such as glucose challenge test and fasting oral glucose tolerance test results, that can help predict which women are likely to need anti-diabetic medications instead of achieving control through lifestyle changes alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of women with gestational diabetes who failed to achieve glycemic control by lifestyle modifications. Krispin, E., Ashkenazi Katz, A., Shmuel, E., et al.[2021]

A study involving 700 women with gestational diabetes showed that a shared care (SC) approach with lifestyle modifications led to a lower rate of macrosomia (11.2% vs. 17.5%) compared to usual care, indicating improved pregnancy outcomes.

While the SC group had a lower average birth weight and reduced macrosomia risk, they also experienced a higher rate of pregnancy-induced hypertension (PIH), suggesting that while lifestyle changes can be beneficial, they may also carry some risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised translational trial of lifestyle intervention using a 3-tier shared care approach on pregnancy outcomes in Chinese women with gestational diabetes mellitus but without diabetes. Yang, X., Tian, H., Zhang, F., et al.[2022]

In a study of 28 women with preexisting type 2 and early A2 gestational diabetes, metformin was found to be as effective as insulin for glycemic control, with no significant differences in glucose measures between the two groups.

Women treated with metformin experienced significantly fewer episodes of hypoglycemia compared to those on insulin, suggesting that metformin may be a safer option for managing diabetes during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metformin compared with insulin in the treatment of pregnant women with overt diabetes: a randomized controlled trial. Hickman, MA., McBride, R., Boggess, KA., et al.[2013]

In a study of 1269 women with gestational diabetes, those treated with metformin experienced fewer adverse maternal and neonatal outcomes compared to those treated with insulin, including lower rates of Caesarean deliveries and preterm births.

While metformin treatment was associated with better outcomes, it is important to note that women on insulin had higher baseline BMIs and fasting glucose levels, which may have influenced the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metformin for gestational diabetes in routine clinical practice. Goh, JE., Sadler, L., Rowan, J.[2022]

In a study of 25 women with gestational diabetes mellitus (GDM) who started metformin therapy, 64% achieved good blood sugar control, while 36% required insulin due to inadequate control or intolerance.

Fasting glucose levels during an oral glucose tolerance test were key predictors of metformin response; women with fasting glucose ≤5.2 mmol/L had a 93% chance of responding well to metformin, highlighting the importance of monitoring glucose levels in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting blood glucose predicts response to extended-release metformin in gestational diabetes mellitus. Corbould, A., Swinton, F., Radford, A., et al.[2014]

In a study of 1035 pregnant women, 82.6% achieved successful glycemic control after just two weeks of lifestyle changes, including diet and exercise, highlighting the effectiveness of these interventions for managing gestational diabetes mellitus (GDM).

Younger women (under 35) and those with a pre-pregnancy BMI under 25 had significantly higher rates of glycemic control, suggesting that age and weight management are important factors in the success of lifestyle interventions for GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Lifestyle Changes in Glycemic Control among Pregnant Women with Gestational Diabetes Mellitus. Le, DC., Vu, TB., Tran, TN., et al.[2023]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Characterization of women with gestational diabetes who failed to achieve glycemic control by lifestyle modifications. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Lifestyle intervention in prevention of type 2 diabetes in women with a history of gestational diabetes mellitus: one-year results of the FIN-D2D project. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Lifestyle Intervention in Danish Obese Pregnant Women With Early Gestational Diabetes Mellitus According to WHO 2013 Criteria Does Not Change Pregnancy Outcomes: Results From the LiP (Lifestyle in Pregnancy) Study. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

Introduction of metformin for gestational diabetes mellitus in clinical practice: Has it had an impact? [2016]

5. England pubmed.ncbi.nlm.nih.gov

A randomised translational trial of lifestyle intervention using a 3-tier shared care approach on pregnancy outcomes in Chinese women with gestational diabetes mellitus but without diabetes. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Metformin compared with insulin in the treatment of pregnant women with overt diabetes: a randomized controlled trial. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Metformin for gestational diabetes in routine clinical practice. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Prevention of gestational diabetes by metformin plus diet in patients with polycystic ovary syndrome. [2013]

9. England pubmed.ncbi.nlm.nih.gov

A web-based pedometer programme in women with a recent history of gestational diabetes. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Outcomes for Women with Gestational Diabetes Treated with Metformin: A Retrospective, Case-Control Study. [2020]

11. Australia pubmed.ncbi.nlm.nih.gov

Fasting blood glucose predicts response to extended-release metformin in gestational diabetes mellitus. [2014]

12. Switzerland pubmed.ncbi.nlm.nih.gov

The Effectiveness of Lifestyle Changes in Glycemic Control among Pregnant Women with Gestational Diabetes Mellitus. [2023]