Post Delivery Intervention in Women With Previous Gestational Diabetes Mellitus to Improve Glycaemia (Post-GDM-DNA)

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ClinicalTrials.gov Identifier: NCT06022601

Recruitment Status : Recruiting

First Posted : September 5, 2023

Last Update Posted : September 5, 2023

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Sponsor:

Information provided by (Responsible Party):

Imperial College Healthcare NHS Trust

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Gestational Diabetes	Device: DNA Nudge	Not Applicable

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Detailed Description:

STUDY OBJECTIVES Objectives

To assess:

Effect of intervention on HbA1c at 12 and 24 weeks
Adherence to intervention
Participants' preferred time to commence the study, within the start date allowance of 6 weeks - 6 month post-delivery.
Qualitative data on how participants found post-delivery intervention
Effect of intervention on weight 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

3. STUDY DESIGN We will conduct a feasibility study for an open-label, randomised, controlled trial of a personalised post-delivery intervention (DNA Nudge) to improve weight, glycaemia and cardiovascular function in women with previous GDM.

The study is designed to be remote, to enable the study to begin and continue in the pandemic and minimise barriers to recruitment. Study participants will be provided with equipment and instructions to collect samples and measurements at home. Contact with the research team will be over telephone or Microsoft Teams video call.

We will advertise in diabetes antenatal clinics using word-of-mouth, posters, social media and on departmental emails at Imperial College Healthcare NHS Trust or Imperial College for women with current/previous GDM aged 18-45. We will recruit via Twitter, email and in-person encounters.

We will randomise women to 1 of 2 arms:

Arm 1: Standard dietary and physical activity advice as per NICE guidelines at week 1 (active control arm; n = 25) Arm 2: DNA-based personalised dietary and physical advice delivered by DNA Nudge dietician at week 1 and by DNA Nudge wearable and app for weeks 1-24 (intervention arm; n = 25)

Women not randomised to DNA Nudge will be provided with an activity app/wearable device (Fitbit) to monitor daily step count. All women will be provided with a home BP monitor and weighing scales.

Week 1 Eligibility assessment, consent, randomisation, IPAQ questionnaire, baseline BP and weight, blood sample collected for baseline lipid profile.

Some women will begin the study at 13 weeks post-delivery and coincide with the routine postnatal HbA1c for women with GDM. The routine post-delivery HbA1c will be baseline HbA1c for this study. For women who commence the study outside the 13 weeks post-delivery window, a finger prick blood sample will be used for a baseline HbA1c test.

Women in the control arm will be given standard dietary and physical activity advice by the research team, in line with NICE guidelines.

Women in the DNA Nudge arm will provide a cheek swab for DNA analysis, carried out by DNA Nudge. They will be given personalised dietary advice by a DNA Nudge dietician, and be provided with DNA Nudge wearable, app and instructions.

Week 6:

Telephone/video-call follow-up to check ongoing willingness to participate and assess adherence.

Week 12:

Collect weight and BP data from weeks 1-12, collect blood sample for HbA1c and lipid profile. Check ongoing willingness to participate and assess adherence.

Week 18:

Telephone/video-call follow-up to check ongoing willingness to participate and assess adherence.

Week 24:

Collect weight and BP data from weeks 12-24, follow-up IPAQ questionnaire, collect blood sample for HbA1c and lipid profile, return devices and collect usage data from DNA Nudge. Qualitative questionnaire to explore intervention experience.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Post Delivery Intervention in Women With Previous Gestational Diabetes Mellitus to Improve Glycaemia
Actual Study Start Date :	March 1, 2023
Estimated Primary Completion Date :	September 30, 2024
Estimated Study Completion Date :	September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gestational diabetes

MedlinePlus related topics: Blood Glucose

Drug Information available for: Deoxyribonucleic acid

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: DNA Nudge DNA Nudge wearable and app, DNA-based dietary advice	Device: DNA Nudge DNA Nudge wearable, DNA-based dietary advice
No Intervention: Control Fitbit, standard dietary advice

Outcome Measures

Primary Outcome Measures :

HbA1c [ Time Frame: 12 weeks ]
Glycaemia

Secondary Outcome Measures :

HbA1c [ Time Frame: 24 weeks ]
Glycaemia
Weight [ Time Frame: 12 weeks ]
kg
Weight [ Time Frame: 24 weeks ]
kg
Systolic and diastolic Blood pressure [ Time Frame: 12 weeks ]
mmHg
Systolic and Diastolic Blood pressure [ Time Frame: 24 weeks ]
mmHg

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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,
access to a smartphone with an operating system of iOS 9.0 or above, or Android 5.0 or above

Exclusion Criteria:

Diabetes outside of pregnancy (diagnosis of type 1 or 2 diabetes; or HbA1c 48 mmol/mol or above).
Health contra-indications to moderate-vigorous exercise.
Planning pregnancy during the study period or become pregnant during the study period. -Cancer
kidney disease
liver disease
pancreatitis.
gastric bypass surgery or similar weight loss surgery

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022601

Contacts

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Contact: Edward Mullins	07881029947	edward.mullins@imperial.ac.uk
Contact: Becky Ward	02075949459	becky.ward@imperial.ac.uk

Locations

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United Kingdom
Imperial College Healthcare NHS Trust	Recruiting
London, United Kingdom, W12 0HS
Contact: Edward WS Mullins, PhD 07881029947 edward.mullins@imperial.ac.uk
Principal Investigator: Edward WS Mullins, PhD
Principal Investigator: Christoph C Lees, MD

Sponsors and Collaborators

Imperial College Healthcare NHS Trust

Study Documents (Full-Text)

Documents provided by Imperial College Healthcare NHS Trust:

Study Protocol and Statistical Analysis Plan [PDF] March 8, 2022

More Information

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Responsible Party:	Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier:	NCT06022601
Other Study ID Numbers:	292085
First Posted:	September 5, 2023 Key Record Dates
Last Update Posted:	September 5, 2023
Last Verified:	August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Data will be available on request from the PI
Supporting Materials:	Study Protocol Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Diabetes, Gestational Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases	Endocrine System Diseases Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases

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