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Manchester Intermittent Diet in Gestational Diabetes Acceptability Study

NCT05344066 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-05-03

No results posted yet for this study

Summary

A two-arm non-blinded randomised feasibility protocol trial designed to assess the feasibility, safety, and acceptability of an intermittent low energy diet (ILED) vs best National Health Service (NHS) care in women with gestational diabetes and obesity in Greater Manchester.

Conditions

  • Gestational Diabetes
  • Gestational Diabetes Mellitus in Pregnancy
  • Intermittent Fasting
  • Pregnancy Related
  • Diabetes
  • Diabetes in Pregnancy

Interventions

OTHER

Best NHS Care

Personalised advice and support from a diabetes dietician to follow NICE healthy eating diet and physical activity recommendations for GDM.

OTHER

Intermittent Low Energy Diet

Two non-consecutive days of a food based 1000 kcal diet and five days of the NICE healthy eating diet and physical activity recommendations for the best NHS care group.

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University of Manchester

    collaborator OTHER

  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Basil Issa · Manchester Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-24
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT05344066 on ClinicalTrials.gov