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Pilot Social Network Weight Loss Intervention (HIC)

28. juli 2021 opdateret af: Mark L Wieland, Mayo Clinic

Healthy Immigrant Community: Pilot Social Network Weight Loss Intervention

Specific Aim #1: Pilot test a social network-informed CBPR-derived health promotion program for feasibility outcomes with overweight or obese adults from two immigrant communities.

Specific Aim #2: Assess the preliminary impact of embedding a social network-informed CBPR-derived intervention within a regional health promotion resource hub on sustainability and uptake outcomes.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

The intervention will consist of 12 community-based mentoring and education sessions, group activities and application of a community toolkit for healthy weight loss delivered by trained interventionists from Hispanic and Somali communities to their social networks. Using a pre-post study design, 4 social networks of adults with approximately 32 network participants will receive the intervention. Primary outcomes, measured 3 months after implementation, will include feasibility measures of acceptability, implementation, and practicality. Secondary outcomes will include BMI, waist circumference, blood pressure, fasting blood glucose, total cholesterol, physical activity level, dietary change, and health-related quality of life.

Eligibility criteria include (1) self-identification as Hispanic or Somali, (2) member of an HPs social network, (3) age≥18 and <65 (4) willingness to participate in all aspects of the study; and (5) provision of informed consent. Exclusion criteria include (1) pregnancy at the time of enrollment and (2) serious medical conditions or disabilities that would make physical activity difficult.

We will test how best to integrate a social network intervention within an existing evidence-based regional health promotion infrastructure (WellConnect) that will enhance its potential dissemination and community-wide uptake

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

39

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic

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:

  1. self-identification as Hispanic or Somali
  2. member of an HPs social network
  3. age≥18 and <65
  4. willingness to participate in all aspects of the study
  5. provision of informed consent.

Exclusion Criteria:

  1. pregnancy at the time of enrollment
  2. serious medical conditions or disabilities that would make physical activity difficult.

    • To avoid stigmatization, a normal weight (BMI<25) will not exclude individuals from participating, but they will be excluded from the measurements and analyses.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
All participants will receive education on maintaining a healthy diet and improving physical activity.
12 mentoring/educational sessions focused on physical activity and healthy nutrition by Mayo Clinic experts.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acceptability
Tidsramme: 12 weeks
To what extent did was the intervention judged as relevant, satisfying, or helpful to HPs and participants? Interviews with HPs; focus groups and survey with participants.
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight
Tidsramme: 12 weeks
Weight will be measured to the nearest 0.1 kg using a portable scale (Seca 880 Digital Floor Scale). BMI is calculated as weight (kg)/height squared (m2).
12 weeks
Waist circumference
Tidsramme: 12 weeks
Waist circumference will be measured to the nearest 0.1 cm at the narrowest part of the torso between the ribs and the iliac crest. Participants will remove all excess clothing prior to the measurement and smooth the remaining clothing against the skin. Two measurements will be taken; if the difference between the two measures is more than 2.0 cm, a third measurement will be taken. The average of the two closest measures will be used for analyses.
12 weeks
Glucose
Tidsramme: 12 weeks
Collected by a single finger prick. Participants will be asked to refrain from eating for at least 6 hours prior to testing. Samples used for testing are whole blood from a fingerstick collected in a lithium heparin coated capillary tube.
12 weeks
Cholesterol
Tidsramme: 12 weeks
Collected by a single finger prick. Participants will be asked to refrain from eating for at least 6 hours prior to testing. The portable Whole Blood Lipid Screen Cholestech LDX Analyzer will be used to analyze specimens, which combines enzymatic methodology and solid-phase technology measured by reflectance photometry to measure total cholesterol, HDL cholesterol, triglycerides and glucose in whole blood. LDL cholesterol is a calculated value. Samples used for testing are whole blood from a fingerstick collected in a lithium heparin coated capillary tube. Results will be recorded at the site of collection and samples will be destroyed upon recording of results.
12 weeks
Height
Tidsramme: 12 weeks
Height will be measured to the nearest 0.1 cm at baseline only using a stadiometer.
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Mark Wieland, MD, Mayo Clinic

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.

Hjælpsomme links

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)

28. januar 2020

Primær færdiggørelse (Faktiske)

26. juni 2020

Studieafslutning (Faktiske)

30. juni 2020

Datoer for studieregistrering

Først indsendt

12. februar 2020

Først indsendt, der opfyldte QC-kriterier

14. februar 2020

Først opslået (Faktiske)

18. februar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 19-011574

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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