REmote SUpport for Low-Carbohydrate Treatment of Type 2 Diabetes

NCT04916314 | Completed Results DMC

• 1 other identifier: 15434
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diet; Low-Carbohydrate; Digital Intervention

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Participants' HbA1c

  Change in participants' HbA1c from baseline to 3 months

  Baseline to 3 months

• Change From Baseline in Participants' HbA1c

  Change in participants' HbA1c from baseline to 12 months

  Baseline to 12 months

Secondary Outcomes (11)

• Diabetes Remission at 12 Months

  1 year

• Weight Change From Baseline

  3 months,1 year

• Change in Systolic Blood Pressure, From Baseline

  3 months, 1 year

• Change in Diastolic Blood Pressure, From Baseline

  3 months, 1 year

• Change in LDL Cholesterol From Baseline

  3 months, 1 year

Other Outcomes (5)

• Dietary Intake Patterns

  Baseline, 3 months, 1 year

• Engagement With Programme; 'Learn' Component of the Programme

  Baseline, 3 months, 1 year

• Engagement With Programme; 'Track' Component of the Programme

  Baseline, 3 months, 1 year

Study Arms (2)

Low Carbohydrate Diet

EXPERIMENTAL

. The intervention involves diet, activity and behaviour change components. It comprises a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application. Each participant will also receive a hard copy of an instructional handbook and a recipe book.

Behavioral: Low Carbohydrate diet

Standard NHS type 2 diabetes care

NO INTERVENTION

Participants randomised to the control group will receive no additional intervention, and will continue to receive their usual NHS diabetes care from their general practice.

Interventions

Low Carbohydrate diet BEHAVIORAL

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).

Low Carbohydrate Diet

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 40 years or above.
• Diagnosed with current type 2 diabetes (i.e. not in remission) in the last 6 years
• BMI of ≥27kg/m2 (≥30kg/m2 if ethnicity recorded as white)
• Has a smartphone or computer with internet access (and the correct operating system requirements to use the intervention programme)
• Are able to complete the eligibility and baseline assessments online
• Would like to make changes to their diet or lifestyle to improve their diabetes control, lose weight, or improve their general health

You may not qualify if:

• Unable to understand the study materials and interventions
• Currently following a weight loss programme (defined as a structured, prescribed and monitored programme and not a self-directed weight loss attempt)
• Pregnant, breastfeeding, or planning to become pregnant during the course of the study
• History of bariatric surgery, including gastric banding
• Currently using insulin therapy
• Proliferative diabetic retinopathy, or maculopathy.
• Recent myocardial infarction or stroke (\<3 months)
• Renal failure (chronic kidney disease stage 4 or 5)
• Current active treatment for cancer (other than skin cancer treated with curative intent by local treatment only)
• Their doctor does not feel they are appropriate to participate for another reason (e.g. active eating disorder diagnosis, significant psychological disturbance)

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Warwick, Select A Region, CV34 4NH, United Kingdom

Location

Related Publications (1)

• Morris E, Scragg J, Stevens R, Albury C, Aveyard P, Jebb SA. A randomised controlled trial of a low-carbohydrate digitally-supported weight loss programme for type 2 diabetes. NPJ Digit Med. 2025 Dec 2;8(1):739. doi: 10.1038/s41746-025-02116-w.

  PMID: 41331050 DERIVED

MeSH Terms

Interventions

Diet, Carbohydrate-Restricted

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Dr Elizabeth Morris
• Organization: University of Oxford

RESULT@phc.ox.ac.uk

01865617289

Study Officials

• Paul Aveyard, FRCP

  University of Oxford

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The nature of the intervention means it is not possible to mask providers or patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 7, 2021
• Study Start: July 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: January 5, 2026
• Results First Posted: January 5, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available indefinitely when the investigators have completed their analysis, about 1 year after final follow-up.
• Access Criteria: Request is for bona fide reasons from an organisation whose mission is to benefit the public good.

Locations

GB (1)