Pilot Social Network Weight Loss Intervention (HIC)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- self-identification as Hispanic or Somali
- member of an HPs social network
- age≥18 and <65
- willingness to participate in all aspects of the study
- provision of informed consent.
Exclusion Criteria:
- pregnancy at the time of enrollment
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Intervention
All participants will receive education on maintaining a healthy diet and improving physical activity.
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12 mentoring/educational sessions focused on physical activity and healthy nutrition by Mayo Clinic experts.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Acceptability
Tijdsspanne: 12 weeks
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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.
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12 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Weight
Tijdsspanne: 12 weeks
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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).
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12 weeks
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Waist circumference
Tijdsspanne: 12 weeks
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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.
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12 weeks
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Glucose
Tijdsspanne: 12 weeks
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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.
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12 weeks
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Cholesterol
Tijdsspanne: 12 weeks
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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.
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12 weeks
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Height
Tijdsspanne: 12 weeks
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Height will be measured to the nearest 0.1 cm at baseline only using a stadiometer.
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12 weeks
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mark Wieland, MD, Mayo Clinic
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 19-011574
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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