- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05279729
Effektiviteten av mHealth-apper for helse i en lavinntekts-, type II-diabetiker, latinamerikansk befolkning
Effekten av mHealth-apper for helse hos en lavinntekt, type II-diabetiker, latinamerikansk
The purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes and the subsequent benefit of improving type II diabetes outcomes in a low socioeconomic Hispanic population. This study will involve a 6-month long commitment where participants will be expected to weigh themselves every morning, at the same time, and check their blood glucose readings daily before and after meals for at least three meals in the day.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
California
-
San Diego, California, Forente stater, 92182
- Rekruttering
- San Diego State University
-
Ta kontakt med:
- Robert J Castro, BS
- Telefonnummer: 6193636120
- E-post: rcastro0271@sdsu.edu
-
Hovedetterforsker:
- Mee Young Hong, PhD
-
Hovedetterforsker:
- Robert J Castro, BS
-
Ta kontakt med:
- Mee Young Hong, PhD
- Telefonnummer: 6195942392
- E-post: mhong2@sdsu.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Diagnosed with type II diabetes
- Between the age of 18-64
- BMI ≥ 27
- Individual annual income less than $47,520 [Covered CA income guidelines and salary restrictions]
- Hispanic and/or Latinx origin
- Monitors blood glucose regularly
- Owns or has access to a bathroom weight scale
- Owns a smartphone and willing to download mobile apps
Exclusion Criteria:
- Does not check blood glucose at least once per day
- On medications that promote weight gain such as antipsychotic, antidepressant, and steroid hormone medications.
Medications for diabetes such as insulin, thiazolidinediones or sulfonylureas are okay
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Styre
|
|
|
Eksperimentell: Weight Watchers (WW)
|
Intervention will be with two different mobile health (mHealth) applications, Weight Watchers and Healthi app (formerly iTrackBites) |
|
Eksperimentell: Sunn app
|
Intervention will be with two different mobile health (mHealth) applications, Weight Watchers and Healthi app (formerly iTrackBites) |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Effectiveness of mHealth apps at reducing bodyweight assessed by bodyweight measurements over 6 months
Tidsramme: 6 months
|
Determine if mHealth apps-Weight Watchers (WW) and Healthi app-are an effective weight loss modality compared to standard weight loss program (control) |
6 months
|
|
Most effect intervention for weight loss in first 3 months
Tidsramme: 6 months
|
Compare the three interventions, mHealth apps and control, against each other to determine which is most effective at achieving the maximum amount of weight loss within the first three months |
6 months
|
|
Most effective intervention for weight loss by 6 months
Tidsramme: 6 months
|
Compare and determine which intervention leads to the highest weight loss maintenance after six months |
6 months
|
|
Self-efficacy in weight management assessed by Weight Management and Nutrition Knowledge questionnaire
Tidsramme: 6 months
|
Compare and determine which intervention promotes self-efficacy in weight management |
6 months
|
|
Long term diabetes improvement via A1c
Tidsramme: 6 months
|
Compare and determine which intervention provides the best improvements towards diabetes via blood glucose and HbA1c |
6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire
Tidsramme: 6 months
|
Comparing the three interventions to determine which leads to greater quality of life (QOL) |
6 months
|
|
mhealthy app preference assessed by questionnaire
Tidsramme: 6 months
|
Which mHealth app is more economically feasible for the participants and if feasibility changes after app usage. Outcome will be assessed with a questionnaire asking if the participant can afford the app. |
6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HS-2021-0245
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