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

Primary Purpose

Gestational Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
DNA Nudge
Sponsored by
Imperial College Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Imperial College Healthcare NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DNA Nudge

Control

Arm Description

DNA Nudge wearable and app, DNA-based dietary advice

Fitbit, standard dietary advice

Outcomes

Primary Outcome Measures

HbA1c
Glycaemia

Secondary Outcome Measures

HbA1c
Glycaemia
Weight
kg
Weight
kg
Systolic and diastolic Blood pressure
mmHg
Systolic and Diastolic Blood pressure
mmHg

Full Information

First Posted
June 6, 2023
Last Updated
August 30, 2023
Sponsor
Imperial College Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT06022601
Brief Title
Post Delivery Intervention in Women With Previous Gestational Diabetes Mellitus to Improve Glycaemia
Acronym
Post-GDM-DNA
Official Title
Post Delivery Intervention in Women With Previous Gestational Diabetes Mellitus to Improve Glycaemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College Healthcare NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DNA Nudge
Arm Type
Experimental
Arm Description
DNA Nudge wearable and app, DNA-based dietary advice
Arm Title
Control
Arm Type
No Intervention
Arm Description
Fitbit, standard dietary advice
Intervention Type
Device
Intervention Name(s)
DNA Nudge
Intervention Description
DNA Nudge wearable, DNA-based dietary advice
Primary Outcome Measure Information:
Title
HbA1c
Description
Glycaemia
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
HbA1c
Description
Glycaemia
Time Frame
24 weeks
Title
Weight
Description
kg
Time Frame
12 weeks
Title
Weight
Description
kg
Time Frame
24 weeks
Title
Systolic and diastolic Blood pressure
Description
mmHg
Time Frame
12 weeks
Title
Systolic and Diastolic Blood pressure
Description
mmHg
Time Frame
24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edward Mullins
Phone
07881029947
Email
edward.mullins@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Becky Ward
Phone
02075949459
Email
becky.ward@imperial.ac.uk
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward WS Mullins, PhD
Phone
07881029947
Email
edward.mullins@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Edward WS Mullins, PhD
First Name & Middle Initial & Last Name & Degree
Christoph C Lees, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available on request from the PI

Learn more about this trial

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

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