Motivational Instant Messaging and E-diabetes Prevention Programme for High Risk of Type 2 Diabetes
8. august 2018 opdateret af: King's College London
Effectiveness of Integrating Motivational Instant Messaging Into an E-diabetes Prevention Programme in People at High Risk of Type 2 Diabetes: a Prospective, Parallel-group, Randomised Controlled Trial (Diabetes Stopwatch)
The overall aim of this feasibility trial is to assess the effectiveness of a wearable technology and an e-diabetes prevention programme delivered via a smartphone application, including motivational messaging, in reducing weight and increasing physical activity in people at risk of developing type 2 diabetes.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The study will examine whether a wearable technology, combined with biofeedback, motivational messaging and an e-diabetes prevention programme, is effective in reducing weight and increasing physical activity after 12 months.
The intervention will consist of a wearable technology and a smartphone application made available for a 12 month period. 22 online multimedia sessions targeting diet, physical activity and mental resilience delivered via the smartphone application. Motivational messaging based on the diabetes prevention module content and biofeedback will be sent to participants via the application.
The control group will receive the wearable technology and will have access to a smartphone application detailing their activity. Participants will be directed to the same educational material as is made available via the multimedia sessions, but will not receive motivational messages.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
200
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- HbA1c between 42 and 47 mmol/mol
- BMI≥25 kg/m²
- Fluent in conversational English
- Permanent resident in Lambeth, Southwark or Lewisham
- Ownership of a smartphone (iPhone or Android only) for communication defined as logging on at least once/day to the internet
- Ambulatory.
Exclusion Criteria:
- Known diabetes
- Pregnancy or planning pregnancy during the duration of the study
- Severe mental illness (severe depression, psychosis, bipolar affective disorder, dementia, learning difficulties, substance problem use or dependence)
- Severe physical disability e.g. that would prevent any increased uptake of physical exercise
- Advanced active disease such as cancer or heart failure
- Any other condition which requires glucose altering drugs
- Morbid obesity (BMI ≥50 kg/m²)
- Current participation in a weight loss programme.
When in doubt the investigators will seek the GP opinion and approval.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention
If participants are allocated to the intervention group, participants will receive the wearable technology and access to the smartphone application.
Motivational messages based on diabetes prevention programme content, and biofeedback messages based on physical activity data provided via the wearable technology, will be received by participants via the application.
The diabetes prevention programme educational material will be available via the application.
|
Buddi wearable technology will record activity levels, participants will access activity data through smartphone application
Educational material accessed through smartphone application
Messages sent via smartphone application
|
|
Aktiv komparator: Control
If participants are allocated to the control group, participants will receive the wearable technology and will be able to access their activity data via the smartphone application.
Participants will also have have access to the diabetes prevention programme educational material via the application.
Participants will not receive motivational messages related to the education content or activity data.
|
Buddi wearable technology will record activity levels, participants will access activity data through smartphone application
Educational material accessed through smartphone application
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical activity (average steps per day)
Tidsramme: 7 days
|
Average steps taken per day from 7 days wear measured using the Buddi wearable technology, which will be worn 24 hours per day for 7 days
|
7 days
|
|
Weight (kg)
Tidsramme: At 12 month follow-up appointment
|
Measured in light clothing, without shoes, on the a Class 3 Tanita SC240 weighing digital scale to 0.01 kg for weight
|
At 12 month follow-up appointment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
HbA1c (mmol/mol)
Tidsramme: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
|
Height (cm)
Tidsramme: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
|
BMI (kg/m^2)
Tidsramme: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
|
Waist circumference (cm)
Tidsramme: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
|
Hip circumference (cm)
Tidsramme: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
|
Total cholesterol (mmol/L)
Tidsramme: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
|
High density lipoprotein cholesterol (mmol/L)
Tidsramme: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
|
Low density lipoprotein cholesterol (mmol/L)
Tidsramme: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
|
Systolic blood pressure (mmHg)
Tidsramme: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
|
Diastolic blood pressure (mmHg)
Tidsramme: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
|
Sleep duration (average hours per night)
Tidsramme: 7 days
|
The Buddi wearable technology will be worn for 24 hours per day.
Therefore, during sleeping hours participant activity will be measured and duration of sleep can be calculated.
Participants will wear the Buddi device for 7 days, and the average number of hours sleep per night will be calculated.
|
7 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Khalida Ismail, King's College London
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2016
Primær færdiggørelse (Faktiske)
25. maj 2018
Studieafslutning (Faktiske)
12. juli 2018
Datoer for studieregistrering
Først indsendt
20. september 2016
Først indsendt, der opfyldte QC-kriterier
27. september 2016
Først opslået (Skøn)
29. september 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. august 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. august 2018
Sidst verificeret
1. marts 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 197384
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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