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Trial · NCT06948825

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

NCT06948825, Phase 2, Active not recruiting, George Washington University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes. Trials, record NCT06948825. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06948825

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
NCT number
NCT06948825
Status
Active not recruiting
Phases
Phase 2
Enrollment
41 participants, actual
Lead sponsor
George Washington University
Conditions
Weight Loss, Gestational Diabetes Mellitus in Pregnancy, Postpartum Care
Interventions
Metformin Hcl 850Mg Tab, Lifestyle Intervention, Enhanced Lifestyle Intervention
First posted
2025-04-29
Last updated
2026-11-06

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMean weight change at 6 months6 monthsWeight in kg.
SecondaryChange in physical activity6 months
Measured using the Paffenberger Physical Activity Questionnaire, scores are calculated as total weekly energy expenditure in kilocalories per week; higher scores indicate better physical activity levels.
SecondaryChange in blood pressure6 monthsChange in blood pressure, measured in mmHg. A better blood pressure reading is considered below 120/80 mmHg.
SecondaryChange in A1c6 monthsChange in A1c lab value, measured in percentage (%), where a better A1c value is below 5.7%.
SecondaryChange in lipids6 monthsChange in lipids, measured in mg/dL, where a better outcome is total cholesterol below 200mg/dL, HDL above 60 mg/dL, LDL below 100 mg/dL, and triglycerides below 150 mg/dL.
SecondaryChange in quality of life6 monthsMeasured using the Short-Form Survey 12, where scores range from 0 to 100. Scores higher than 50 indicate better-than-average health.
SecondaryChange in depression score6 months
Measured using the Edinburgh Postnatal Depression Scale, with scores ranging from 0 to 30, and lower scores indicating better outcomes. A score of 12 or higher indicates the need to connect with a primary care physician or mental health clinician in the GW School of Medicine or the local community. With the participant's permission, the research staff will facilitate this connection.
SecondaryChange in diet quality6 monthsThe research team will review participant diet data via the Ascend platform.
SecondaryBreastfeeding6 monthsA question will be asked at the start and end of the study to determine breastfeeding status.
SecondaryAdherence to Metformin treatment4.5 to 5 monthsParticipants will complete a Metformin adherence questionnaire every 2 weeks.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers24

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
7479629BACKGROUNDPubMed
9515998BACKGROUNDPubMed
11333990BACKGROUNDPubMed
11547793BACKGROUNDPubMed
11832527BACKGROUNDPubMed
12436333BACKGROUNDPubMed
12545145BACKGROUNDPubMed
15932841BACKGROUNDPubMed
16936160BACKGROUNDPubMed
17596462BACKGROUNDPubMed

1 to 10 of 24

See all 24 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06948825

GET https://conductscience.org/api/trials/v1/NCT06948825/papers?page=2