NCT05136339

Brief Summary

The objective of this study is to leverage existing social networks for health behavior change relevant to obesity and cardiovascular risk among immigrant populations in Southeast, Minnesota.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
475

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 29, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

April 23, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 27, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2.4 years

First QC Date

November 16, 2021

Results QC Date

August 26, 2025

Last Update Submit

January 23, 2026

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (4)

  • Change in Weight

    Difference in weight (measured in kilograms) from baseline to 6 months and from baseline to 12 months

    Baseline, 6 months, 12 months

  • Change in Waist Circumference From Baseline to 6 Months and From Baseline to 12 Months

    Measured to the nearest 0.1 cm at the narrowest part of the torso between the ribs and the iliac crest.

    Baseline, 6 months, 12 months

  • Change in "Life's Simple 6" Composite Score From Baseline to 6 Months and From Baseline to 12 Months

    Adapted from the American Heart Association standards based on health assessment data. Point values are assigned to each component: 2 points for ideal, 1 point for intermediate, 0 points for poor. The total sum allows for a continuous measure of cardiovascular health ranging from poor to ideal (0-12 points).

    Baseline, 6 months, 12 months

  • Lost >5% of Body Weight

    Number of participants in each arm who lost a clinically significant amount of weight (\>5%).

    6 months, 12 months

Secondary Outcomes (6)

  • Change in Systolic Blood Pressure

    Baseline, 6 months, 12 months

  • Change in Fasting Glucose Level

    Baseline, 6 months, 12 months

  • Change in Low-density Lipoprotein (LDL)

    Baseline, 6 months, 12 months

  • Change in Dietary Quality

    Baseline, 6 months, 12 months

  • Change in Physical Activity

    Baseline, 6 months, 12 months

  • +1 more secondary outcomes

Study Arms (2)

Immediate Community-Based Mentoring and Education Sessions

EXPERIMENTAL

Subjects will receive the intervention of community-based mentoring and education sessions immediately after enrollment.

Behavioral: Community-based mentoring and education sessions

Delayed Community-Based Mentoring and Education Sessions

EXPERIMENTAL

Subjects will receive the intervention of community-based mentoring and education sessions approximately 12 months after enrollment.

Behavioral: Community-based mentoring and education sessions

Interventions

Community-based mentoring and education sessionsBEHAVIORAL

Community-based mentoring and education sessions, group activities, and application of a community toolkit for healthy weight loss delivered by trained Health Promoters from Hispanic and Somali communities to their social networks.

Delayed Community-Based Mentoring and Education SessionsImmediate Community-Based Mentoring and Education Sessions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identification as Hispanic or Somali.
  • Member of a social network identified in the social network analysis.
  • Willingness to participate in all aspects of the study.
  • Provision of informed consent.

You may not qualify if:

  • 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 in the intervention, but they will be excluded from the measurements and analyses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (5)

  • Tranby B, Sia I, Clark M, Novotny P, Lohr A, Suarez Pardo L, Patten C, Iteghete S, Zeratsky K, Rieck T, Molina L, Porraz Capetillo G, Ahmed Y, Dirie H, Wieland M. Self-Efficacy Is Associated with Health Behaviors Related To Obesity and Cardiovascular Risk Among Hispanic/Latinx and Somali Immigrants To the United States. J Immigr Minor Health. 2025 Dec 11. doi: 10.1007/s10903-025-01812-9. Online ahead of print.

    PMID: 41379348DERIVED

  • Tranby B, Sia I, Clark M, Novotny P, Lohr A, Pardo LS, Patten C, Iteghete S, Zeratsky K, Rieck T, Molina L, Capetillo GP, Ahmed Y, Dirie H, Wieland M. Self-Efficacy is Associated with Health Behaviors Related to Obesity and Cardiovascular Risk among Hispanic/Latinx and Somali Immigrants to the United States. Res Sq [Preprint]. 2025 Feb 19:rs.3.rs-6001516. doi: 10.21203/rs.3.rs-6001516/v1.

    PMID: 40034444DERIVED

  • Tranby BN, Sia IG, Clark MM, Novotny PJ, Lohr AM, Pardo LS, Patten CA, Iteghete SO, Zeratsky KA, Rieck TM, Molina L, Capetillo GP, Ahmed Y, Dirie H, Wieland ML. Negative mood is associated with sociobehavioral factors contributing to cardiovascular risk in an immigrant population. BMC Public Health. 2024 Jul 16;24(1):1911. doi: 10.1186/s12889-024-19402-z.

    PMID: 39014369DERIVED

  • Lohr AM, Pratt R, Dirie H, Ahmed Y, Elmi H, Nur O, Osman A, Novotny P, Mohamed AA, Griffin JM, Sia IG, Wieland ML. The Association Between Perceived Discrimination, Age and Proportion of Lifetime in the United States Among Somali Immigrants: A Cross-Sectional Analysis. J Immigr Minor Health. 2024 Aug;26(4):689-698. doi: 10.1007/s10903-024-01589-3. Epub 2024 Jul 18.

    PMID: 38578534DERIVED

  • Tranby BN, Sia IG, Clark MM, Novotny PJ, Lohr AM, Pardo LS, Patten CA, Iteghete SO, Zeratsky KA, Rieck TM, Molina L, Capetillo GP, Ahmed Y, Drie H, Wieland ML. Negative Mood is Associated with Sociobehavioral Factors Contributing to Cardiovascular Risk in an Immigrant Population. Res Sq [Preprint]. 2024 Mar 12:rs.3.rs-3934645. doi: 10.21203/rs.3.rs-3934645/v1.

    PMID: 38559259DERIVED

Related Links

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Mark Wieland
Organization
Mayo Clinic
wieland.mark@mayo.edu
507-250-5993

Study Officials

  • Mark Wieland, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 29, 2021

Study Start

April 23, 2022

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

January 27, 2026

Results First Posted

January 27, 2026

Record last verified: 2026-01

Locations

US(1)