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REmote SUpport for Low-Carbohydrate Treatment of Type 2 Diabetes

NCT04916314 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2026-01-05

Study results available
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Summary

Excess adiposity is a key causal factor in developing type 2 diabetes and weight loss improves glycaemia and can put diabetes in to remission. There is evidence that low carbohydrate diets also reduce glycaemia. The aim of this trial is to test a behavioural support programme delivered remotely to reduce energy intake and carbohydrate intake in particular to improve glycaemic control in people recently diagnosed with type 2 diabetes. We will recruit participants from general practice diabetes registers who were diagnosed within the past six years and who want to and are able to follow an app-based behavioural support programme to change their diet and have a BMI of at least 27kg/m2 (≥30kg/m2 if of white European ethnicity). They will be individually randomised 1:1 using simple randomisation to either intervention or a no-intervention control. Blinding of participants or their clinicians is impossible. The intervention comprises a 12-week behavioural support programme delivered by app or web, which provides group-based peer support, recipes for food providing low energy meals that are low in carbohydrate. The programme is delivered by a commercial company who run NHS commissioned programmes in several areas of the UK. Clinicians will adjust medication for hypertension and diabetes as needed. The co-primary outcomes are change in participants' HbA1c from baseline to 3 months and baseline to 1 year, with p-value adjustment to reflect multiple testing. The secondary outcomes are remission from diabetes, weight change, change in cardiovascular risk factors, and change in quality of life at 3 months and 1 year. The trial will assess whether this app-based programme improves outcomes for people with type 2 diabetes relative to usual care.

Conditions

  • Type 2 Diabetes Mellitus in Obese

Interventions

BEHAVIORAL

Low Carbohydrate diet

The intervention is a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), encouraging adoption of a low energy, low-carbohydrate diet, peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application; each participant additionally receives an instructional handbook, and recipe book (+/-wireless weighing and activity tracking technology).

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Paul Aveyard, FRCP · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-10-01
Completion
2023-10-01

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 NCT04916314 on ClinicalTrials.gov