NCT06022601

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

1.6 years

First QC Date

June 6, 2023

Last Update Submit

August 30, 2023

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Glycaemia

    12 weeks

Secondary Outcomes (5)

  • HbA1c

    24 weeks

  • Weight

    12 weeks

  • Weight

    24 weeks

  • Systolic and diastolic Blood pressure

    12 weeks

  • Systolic and Diastolic Blood pressure

    24 weeks

Study Arms (2)

DNA Nudge

EXPERIMENTAL

DNA Nudge wearable and app, DNA-based dietary advice

Device: DNA Nudge

Control

NO INTERVENTION

Fitbit, standard dietary advice

Interventions

DNA NudgeDEVICE

DNA Nudge wearable, DNA-based dietary advice

DNA Nudge

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Edward Mullins

CONTACT

07881029947edward.mullins@imperial.ac.uk

Becky Ward

CONTACT

02075949459becky.ward@imperial.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

September 5, 2023

Study Start

March 1, 2023

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

September 5, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

Data will be available on request from the PI

Shared Documents
STUDY PROTOCOL, ICF

Locations

GB(1)