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Post Delivery Intervention in Women With Previous Gestational Diabetes Mellitus to Improve Glycaemia

NCT06022601 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-09-05

No results posted yet for this study

Summary

STUDY SUMMARY

TITLE Post-delivery intervention in women with previous gestational diabetes mellitus for weight loss, glycaemia and cardiovascular health DESIGN Feasibility study Allocation: RCT AIMS To determine the feasibility of a post-delivery intervention to improve glycemia and cardiovascular function and promote weight loss in women who have had gestational diabetes.

OUTCOME MEASURES Primary outcome; Effect of intervention on HbA1c: difference in HbA1c between intervention arm and control arm measured at 12 weeks.

Secondary Outcomes;

* Adherence to intervention;
* Willingness to be randomised to post-delivery intervention;
* Process measures to evaluate patient experience of study and intervention;
* Participants' preferred time to commence the study, within the start date allowance of 6 weeks - 6 month post-delivery.
* Between-arm differences and within-arm differences to evaluate:

* Effect of intervention on HbA1c at 12 and 24 weeks
* Effect of intervention on weight and BMI at 12 and 24 weeks
* Effect of intervention on systolic and diastolic blood pressure at 12 and 24 weeks
* Effect of intervention on lipid profile (total cholesterol, HDL, LDL) at 12 and 24 weeks
* Effect of intervention on physical activity at 12 and 24 weeks POPULATION We will recruit 50 women aged 18-45 with previous gestational diabetes and randomise them to 1 of 2 arms to commence study at 6 weeks - 6 months post-delivery. Women starting the study at 13 weeks post-delivery will have their routine post-delivery HbA1c act as baseline HBA1c.

ELIGIBILITY Pregnant women with gestational diabetes (women will be given the option to start the study between 6 weeks and 6 months post-delivery) or women who have given birth in the last 12 months and had gestational diabetes during that pregnancy; aged 18-45; and access to a smartphone with an operating system of iOS 9.0 or above, or Android 5.0 or above.

DURATION Study duration: 1/4/21-1/9/22. Participant duration: 24 weeks

Conditions

  • Gestational Diabetes

Interventions

DEVICE

DNA Nudge

DNA Nudge wearable, DNA-based dietary advice

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06022601 on ClinicalTrials.gov