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Evidence-based Text Messages to Target Diet and Physical Activity

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05641402
Recruitment Status : Recruiting
First Posted : December 7, 2022
Last Update Posted : December 7, 2022
Sponsor:
Collaborators:
University of Oxford
Manchester University NHS Foundation Trust
Northern Care Alliance NHS Foundation Trust
Information provided by (Responsible Party):
Yvonne Kiera Bartlett, University of Manchester

Brief Summary:
This research aims to develop a bank of text messages based on behaviour change techniques targeting specific diet and physical activity behaviours in people with type 2 diabetes

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: Text messages Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Developing Evidence-based Text Messages to Target Diet and Physical Activity Behaviour for People With Type 2 Diabetes Mellitus
Actual Study Start Date : July 14, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : October 29, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experienced acceptability study
The final study in this research will involve people with type 2 diabetes receiving the text messages
Other: Text messages
Text messages based on behaviour change techniques




Primary Outcome Measures :
  1. Experienced Acceptability of the text messages for people with type 2 diabetes [ Time Frame: 3.5 months ]
    Assessed through interviews following receiving the text messages


Secondary Outcome Measures :
  1. Anticipated Acceptability [ Time Frame: 60 minutes ]
    Assessed through online survey

  2. Rating of fidelity to intended behaviour change technique [ Time Frame: 60 minutes ]

    How well the text messages represent their intended behaviour change technique. For each behaviour change technique, participants will be presented with the title and description of the technique from the Behaviour change Technique (BCT) v1 taxonomy (Michie et al., 2013, doi: 10.1007/s12160-013-9486-6), and then sample messages. For each message participants will be asked "How well does this message reflect the [specific technique] as defined above?". Answers were given on a 10-point scale anchored with 1 (not very well) to 10 (very well).

    This scale has been used in our previous work developing text messages (Bartlett et al., 2020, doi: 10.2196/15989)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • For the expert workshop -

Inclusion criteria: researchers with expertise in behaviour change, physical activity, diet and/or diabetes

- For focus group

Inclusion criteria

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or female, aged 18 years or above.
  • A diagnosis of type 2 diabetes.
  • Has access to a mobile-phone (shared access is allowed with permission of phone owner)
  • Able to use a mobile phone, if necessary with help, to send or retrieve brief messages (including text-messages or messaging within smartphone applications).

Exclusion criteria

Moved out of England prior to taking part in the study

For the anticipated acceptability survey and experienced acceptability study

Inclusion criteria

  • Participant is willing and able to give informed consent for participation in the study.
  • Aged 18 years or above.
  • A diagnosis of type 2 diabetes.
  • Has access to a mobile-phone (shared access is allowed with permission of phone owner)
  • Able to use a mobile phone, if necessary with help, to send or retrieve brief messages (including text-messages).

Exclusion criteria

  • Within three months of a hospital admission for hyperglycaemia or hypoglycaemia.
  • Pregnant or within three months post-partum by self-report
  • Underweight (For anticipated acceptability this will be by self-report, for experienced acceptability BMI<18.5)
  • Historical or current diagnosis of an eating disorder

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): NCT05641402


Contacts
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Contact: Kiera Bartlett, PhD (+44)161 3065436 kiera.bartlett@manchester.ac.uk
Contact: David P French, PhD (0161) 275 2605 david.french@manchester.ac.uk

Locations
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United Kingdom
University of Manchester Recruiting
Manchester, United Kingdom, M139PL
Contact: Kiera Bartlett, PhD    (+44)161 3065436    kiera.bartlett@manchester.ac.uk   
Sponsors and Collaborators
University of Manchester
University of Oxford
Manchester University NHS Foundation Trust
Northern Care Alliance NHS Foundation Trust
Publications:
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Responsible Party: Yvonne Kiera Bartlett, Lecturer, University of Manchester
ClinicalTrials.gov Identifier: NCT05641402    
Other Study ID Numbers: NIHR202832
First Posted: December 7, 2022    Key Record Dates
Last Update Posted: December 7, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Subject to participant consent. Plan to upload the deidentified survey data with codebook Will explore uploading deidentified transcripts if a relevant database is found
Time Frame: By December 2023
Access Criteria: Dependent on the database chosen

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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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases