Motivational Instant Messaging and E-diabetes Prevention Programme for High Risk of Type 2 Diabetes
8. august 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
200
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Khalida Ismail, King's College London
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. oktober 2016
Primær fullføring (Faktiske)
25. mai 2018
Studiet fullført (Faktiske)
12. juli 2018
Datoer for studieregistrering
Først innsendt
20. september 2016
Først innsendt som oppfylte QC-kriteriene
27. september 2016
Først lagt ut (Anslag)
29. september 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. august 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. august 2018
Sist bekreftet
1. mars 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 197384
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .