15-minute Individual Consultation to Improve Blood Glucose Control in Pre-diabetes

NCT03483129 | Completed

• 1 other identifier: 239910
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This research will assess the feasibility of conducting a randomised control trial to evaluate the effectiveness of a 15-minute one-to-one consultation to improve blood glucose control in pre-diabetes. The consultation will take the form of a 15-minute one-to-one consultation between a health-care practitioner and the patient in a primary care setting. Patients with a glycated haemoglobin (HbA1c) of between 42 and 47 mmol·mol-1 will be identified in general practise and will be eligible to participate. They will attend testing sessions at baseline (before the consultation), and at three months and six months post consultation. Body mass index (BMI), waist and hip girth, blood pressure and body composition will be recorded and blood analysed for HbA1c, cholesterol and dietary components. For a three-week period following each visit, urine will be collected, a 5-ml sample on nine occasions, and physical activity will be recorded in a sub group of participants. Urine will be analysed by flow infusion electrospray mass spectrometry (FIE-MS) to determine the metabolic content, providing an indication of the diet over the three-week sampling period. The research objectives are to assess the effectiveness of recruitment strategy and willingness of patients to engage in, and adhere to, the research process; to determine the impact of consultation on health outcome measures, including HbA1c, and to establish participant and practitioner perspectives of the consultation.

Conditions

Pre-Diabetes

Outcome Measures

Primary Outcomes (1)

• Percentage of eligible patients recruited into the study assessed by study attendance and surgery patient records

  Quantify the percentage (%) of patients enrolled in the study based on letters of invitation sent to eligible participants from their surgery

  Baseline

Secondary Outcomes (10)

• Change in HbA1c assessed by blood Hba1c assessment

  Change assessed between baseline and 3 months, baseline and 6 months, 3 months and 6 months

• Change in BMI assessed by aggregation of height and weight

  Change assessed between baseline and 3 months, baseline and 6 months, 3 months and 6 months

• Change in waist circumference assessed by anthropometric measurement

  Change assessed between baseline and 3 months, baseline and 6 months, 3 months and 6 months

• Change in hip circumference assessed by anthropometric measurement

  Change assessed between baseline and 3 months, baseline and 6 months, 3 months and 6 months

• Change in fat percentage assessed by bioelectrical impedance analysis

  Change assessed between baseline and 3 months, baseline and 6 months, 3 months and 6 months

Study Arms (2)

Consultation

EXPERIMENTAL

The consultation will provide the participant with one to one information regarding the benefits of physical activity and healthy eating. Emphasis will placed on the importance of achieving at least 150 minutes of moderate physical activity each week as well as adhering to healthy dietary habits, based on the NHS Eatwell Guide (Eatwell Guide, 2016). Furthermore, participants will have the opportunity to discuss pre-diabetes with a trained practice nurse and ask any questions they may have.

Behavioral: Consultation

Control

NO INTERVENTION

All participants will receive an information leaflet detailing pre-diabetes, the associated risks and steps that can be taken to avoid developing diabetes.

Interventions

Consultation BEHAVIORAL

15 minute, one to one consultation with a trained practice nurse at a GP surgery. Participants will have the opportunity to discuss pre-diabetes, the risks of developing diabetes and the steps that can be taken to improve lifestyle behaviors and reduce the risk of diabetes development.

Consultation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide consent
• Registered with a mid-Wales GP surgery
• Glycated haemoglobin between 42 mmol·mol-1 and 47 mmol·mol-1 (\< 1 year)

You may not qualify if:

• Under judicial control
• Unable to understand and follow instructions due to cognition or language problems
• During participant identification, general practice will exclude any patients they believe are unsuitable for study involvement, for example, terminal illness

Sponsors & Collaborators

• Aberystwyth University: lead
• Hywel Dda Health Board: collaborator

Study Sites (1)

Carwyn James Building

Aberystwyth, Ceredigion, SY23 3FD, United Kingdom

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Rhys Thatcher, Dr

  Aberystwyth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomised into either the intervention or the control group. Participants in INT will receive a 15 minute one to one consultation with a nurse at their general practice. The consultation will provide the participant with information regarding the benefits of physical activity and healthy eating. Emphasis will placed on the importance of achieving at least 150 minutes of moderate physical activity each week as well as adhering to healthy dietary habits, based on the NHS Eatwell Guide. Participants will have the opportunity to discuss pre-diabetes with a nurse and ask any questions they may have. Participants placed in CON will not receive the consultation and will only attend visits to the WARU. A subgroup of participants will also be randomised for additional physical activity monitoring.

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 30, 2018
• Study Start: April 25, 2018
• Primary Completion: January 23, 2019
• Study Completion: January 23, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)