- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07845461
Testing Intervention Strategies for Addressing Binge Eating and Food Insecurity
The purpose of this study is to conduct a randomized trial to assess whether different stipend distribution schedules and access to a mobile intervention can help reduce binge eating and improve food security status among adults experiencing food insecurity and recurrent binge eating.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Andrea Graham, PhD
- Telefonnummer: 312-503-5266
- E-mail: andrea.graham@northwestern.edu
Studiesteder
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60611
- Rekruttering
- Northwestern University Feinberg School of Medicine
-
Kontakt:
- Andrea Graham, PhD
- Telefonnummer: 312-503-5266
- E-mail: andrea.graham@northwestern.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adult 18 years or older
- English-speaking
- Non-pregnant
- Recurrent binge eating (≥12 episodes in the past 3 months)
- Low or very low food security (score ≥2 on the 6-item 30-day Short Form Food Security Survey)
- Willing to use a mobile application
- Has a smartphone with Internet access and capacity for calls and text messaging
- Has a valid email address
- Willing to complete a W-9 form
- Have an active U.S. bank account to which they can and are willing to receive electronic funds transfer
Exclusion Criteria:
- BMI of less than 19.5
- Diagnosis for which the study/intervention is not clinically indicated
- Currently working with a clinical professional to receive services for weight management or binge eating
- Started or recently changed (within past month) dosage for a medication for weight loss or binge eating
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Monthly Stipend & No App
Participants will receive a monthly stipend for four months to aid with implementing health behavior changes. |
Participants will receive a monthly stipend for four months to aid with implementing health behavior changes. |
|
Eksperimentel: Monthly Stipend & FoodSteps App
Participants will receive a monthly stipend for four months to aid with implementing health behavior changes, and access to the FoodSteps app. |
Participants will receive a monthly stipend for four months to aid with implementing health behavior changes. Participants will get access to the FoodSteps digital intervention for 16 weeks |
|
Eksperimentel: Weekly Stipend & No App
Participants will receive a weekly stipend for four months to aid with implementing health behavior changes. |
Participants will receive a weekly stipend for four months to aid with implementing health behavior changes. |
|
Eksperimentel: Weekly Stipend & FoodSteps App
Participants will receive a weekly stipend for four months to aid with implementing health behavior changes, and access to the FoodSteps app. |
Participants will get access to the FoodSteps digital intervention for 16 weeks Participants will receive a weekly stipend for four months to aid with implementing health behavior changes. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in binge eating
Tidsramme: 4 months
|
Change in number of binge eating episodes |
4 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STU00225460
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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