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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483129
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Hywel Dda Health Board
Information provided by (Responsible Party):
Aberystwyth University

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.

Condition or disease Intervention/treatment Phase
Pre-Diabetes Behavioral: Consultation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Examining the Feasibility of Conducting a Randomised Control Trial to Evaluate the Effectiveness of a Focused 15-minute One-to-one Consultation to Improve Blood Glucose Control in Pre-diabetes
Actual Study Start Date : April 25, 2018
Actual Primary Completion Date : January 23, 2019
Actual Study Completion Date : January 23, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Consultation
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
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.

No Intervention: Control
All participants will receive an information leaflet detailing pre-diabetes, the associated risks and steps that can be taken to avoid developing diabetes.



Primary Outcome Measures :
  1. Percentage of eligible patients recruited into the study assessed by study attendance and surgery patient records [ Time Frame: Baseline ]
    Quantify the percentage (%) of patients enrolled in the study based on letters of invitation sent to eligible participants from their surgery


Secondary Outcome Measures :
  1. Change in HbA1c assessed by blood Hba1c assessment [ Time Frame: Change assessed between baseline and 3 months, baseline and 6 months, 3 months and 6 months ]
    To determine the impact of the consultation on changes in HbA1c (mmol)

  2. Change in BMI assessed by aggregation of height and weight [ Time Frame: Change assessed between baseline and 3 months, baseline and 6 months, 3 months and 6 months ]
    To determine the impact of the consultation on changes in BMI (kg/m2). Data on height (cm) and weight (kg) aggregated to report BMI.

  3. Change in waist circumference assessed by anthropometric measurement [ Time Frame: Change assessed between baseline and 3 months, baseline and 6 months, 3 months and 6 months ]
    To determine the impact of the consultation on changes in waist circumference (cm)

  4. Change in hip circumference assessed by anthropometric measurement [ Time Frame: Change assessed between baseline and 3 months, baseline and 6 months, 3 months and 6 months ]
    To determine the impact of the consultation on changes in hip circumference (cm)

  5. Change in fat percentage assessed by bioelectrical impedance analysis [ Time Frame: Change assessed between baseline and 3 months, baseline and 6 months, 3 months and 6 months ]
    To determine the impact of the consultation on changes in fat percentage (%)

  6. Change in HDL assessed by blood lipid assessment [ Time Frame: Change assessed between baseline and 3 months, baseline and 6 months, 3 months and 6 months ]
    To determine the impact of the consultation on changes in HDL (mmol)

  7. Change in LDL assessed by blood lipid assessment [ Time Frame: Change assessed between baseline and 3 months, baseline and 6 months, 3 months and 6 months ]
    To determine the impact of the consultation on changes in LDL (mmol)

  8. Change in Cholesterol assessed by blood lipid assessment [ Time Frame: Change assessed between baseline and 3 months, baseline and 6 months, 3 months and 6 months ]
    To determine the impact of the consultation on changes in cholesterol (mmol)

  9. Change in physical activity level assessed by Actigraph and Physical Activity Questionnaire [ Time Frame: Change assessed between baseline and 3 months, baseline and 6 months, 3 months and 6 months ]
    To determine the impact of the consultation on changes in physical activity (met minutes)

  10. Change in the urinary concentration of metabolites of high health importance assessed by FIE-MS [ Time Frame: Change assessed between baseline and 3 months, baseline and 6 months, 3 months and 6 months ]
    To determine the impact of the consultation on changes in the concentration urinary of metabolites (µM/mM) of high health importance



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483129


Locations
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United Kingdom
Carwyn James Building
Aberystwyth, Ceredigion, United Kingdom, SY23 3FD
Sponsors and Collaborators
Aberystwyth University
Hywel Dda Health Board
Investigators
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Principal Investigator: Rhys Thatcher, Dr Aberystwyth University
  Study Documents (Full-Text)

Documents provided by Aberystwyth University:

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Responsible Party: Aberystwyth University
ClinicalTrials.gov Identifier: NCT03483129    
Other Study ID Numbers: 239910
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will only be accessed by the immediate research team. Any data made available to other researchers will be anonymised and presented as mean and standard deviation.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia