Type 2 Diabetes Clinical Trial
Official title:
Developing Evidence-based Text Messages to Target Diet and Physical Activity Behaviour for People With Type 2 Diabetes Mellitus
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
Status | Recruiting |
Enrollment | 135 |
Est. completion date | October 29, 2023 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Manchester | Manchester |
Lead Sponsor | Collaborator |
---|---|
University of Manchester | Manchester University NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust, University of Oxford |
United Kingdom,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Experienced Acceptability of the text messages for people with type 2 diabetes | Assessed through interviews following receiving the text messages | 3.5 months | |
Secondary | Anticipated Acceptability | Assessed through online survey | 60 minutes | |
Secondary | 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) |
60 minutes |
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