NCT05641402

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

November 17, 2022

Last Update Submit

January 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Experienced Acceptability of the text messages for people with type 2 diabetes

    Assessed through interviews following receiving the text messages

    3.5 months

Secondary Outcomes (2)

  • Anticipated Acceptability

    60 minutes

  • Rating of fidelity to intended behaviour change technique

    60 minutes

Study Arms (1)

Experienced acceptability study

OTHER

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

Other: Text messages

Interventions

Text messages based on behaviour change techniques

Experienced acceptability study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- For focus group
  • 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).

You may not qualify if:

  • Moved out of England prior to taking part in the study
  • For the anticipated acceptability survey and experienced acceptability study
  • 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).
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manchester

Manchester, M139PL, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 23512568BACKGROUND
  • 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.

    PMID: 32401214BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kiera Bartlett, PhD

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 17, 2022

First Posted

December 7, 2022

Study Start

July 14, 2022

Primary Completion

November 23, 2023

Study Completion

June 30, 2024

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

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

Locations