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Evidence-based Text Messages to Target Diet and Physical Activity

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Text messages
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Prescribed insulin for their diabetes

Sites / Locations

  • University of ManchesterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Experienced acceptability study

Arm Description

The final study in this research will involve people with type 2 diabetes receiving the text messages

Outcomes

Primary Outcome Measures

Experienced Acceptability of the text messages for people with type 2 diabetes
Assessed through interviews following receiving the text messages

Secondary Outcome Measures

Anticipated Acceptability
Assessed through online survey
Rating of fidelity to intended behaviour change technique
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)

Full Information

First Posted
November 17, 2022
Last Updated
May 12, 2023
Sponsor
University of Manchester
Collaborators
University of Oxford, Manchester University NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05641402
Brief Title
Evidence-based Text Messages to Target Diet and Physical Activity
Official Title
Developing Evidence-based Text Messages to Target Diet and Physical Activity Behaviour for People With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
October 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
Collaborators
University of Oxford, Manchester University NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Aim: To develop text messages that help people with type 2 diabetes (T2D) improve their diet and level of physical activity What is known: Following diet and physical activity advice helps to reduce the risk of health problems for people with T2D Just telling people about a healthy diet, or ideal levels of physical activity may not change what someone does day-to-day. Many people need support to change health behaviours Techniques designed to help people change their behaviour, such as setting goals, can help people act Text messages can be sent to large numbers of people, for a low cost For the best chance of success, it is important that the messages are a) acceptable to the people receiving them and b) use techniques to help people to make changes How the investigators are going to achieve their aim: When asking someone to follow a healthy diet or do more physical activity, this could refer to changing lots of different behaviours such as eating less sugar or less fat and walking each day. The investigators invited people with type 2 diabetes, doctors, nurses, dietitians, and researchers to take part in a workshop to work out which behaviours are the most important ones for people with type 2 diabetes to do. The investigators have also looked at previous research and found techniques that have helped people with type 2 diabetes change their diet and levels of activity. The investigators will now follow four steps to develop the messages: Twelve to fifteen people with type 2 diabetes will take part in online focus groups to provide feedback about the target behaviours and guide the development of the text message system Ten to twenty researchers will take part in a workshop. They will write messages using the techniques that have worked in previous research to target important behaviours for people with type 2 diabetes. They will then complete a survey to report whether the messages are good examples of the techniques. 2. Sixty people with type 2 diabetes will complete a survey to tell us whether they like and understand the messages and how useful they think they would be. 3. Forty people with type 2 diabetes will receive the messages for up to 3 months and take part in an interview over the phone to help us understand their experiences. Patient and Public Involvement and Engagement (PPIE) This research has been developed with a PPIE group. Our PPIE co-applicant and PPIE group will be involved in key decisions and review any materials being sent to people with type 2 diabetes. What the investigators will do with the findings Explore how these messages can become part of routine National Health Service (NHS) care. The findings will be used together with work our team are doing looking at sending out text messages to help people with type 2 diabetes take their medication. Findings will also be publicised through databases of people interested in research, diabetes charities, community groups, places of worship and publications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experienced acceptability study
Arm Type
Other
Arm Description
The final study in this research will involve people with type 2 diabetes receiving the text messages
Intervention Type
Other
Intervention Name(s)
Text messages
Intervention Description
Text messages based on behaviour change techniques
Primary Outcome Measure Information:
Title
Experienced Acceptability of the text messages for people with type 2 diabetes
Description
Assessed through interviews following receiving the text messages
Time Frame
3.5 months
Secondary Outcome Measure Information:
Title
Anticipated Acceptability
Description
Assessed through online survey
Time Frame
60 minutes
Title
Rating of fidelity to intended behaviour change technique
Description
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)
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 Prescribed insulin for their diabetes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kiera Bartlett, PhD
Phone
(+44)161 3065436
Email
kiera.bartlett@manchester.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
David P French, PhD
Phone
(0161) 275 2605
Email
david.french@manchester.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiera Bartlett, PhD
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manchester
City
Manchester
ZIP/Postal Code
M139PL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiera Bartlett, PhD
Phone
(+44)161 3065436
Email
kiera.bartlett@manchester.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing Time Frame
By December 2023
IPD Sharing Access Criteria
Dependent on the database chosen
Citations:
PubMed Identifier
23512568
Citation
Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.
Results Reference
background
PubMed Identifier
32401214
Citation
Bartlett YK, Farmer A, Rea R, French DP. Use of Brief Messages Based on Behavior Change Techniques to Encourage Medication Adherence in People With Type 2 Diabetes: Developmental Studies. J Med Internet Res. 2020 May 13;22(5):e15989. doi: 10.2196/15989.
Results Reference
background

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Evidence-based Text Messages to Target Diet and Physical Activity

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