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Weight LossNCT05136339

Healthy Immigrant Community: Mobilizing the Power of Social Networks

A study testing Community-based mentoring and education sessions in people with Weight Loss, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Weight Loss
What is being tested?
Community-based mentoring and education sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
475 participants
Where
1 siteUnited States
Study dates
23 Apr 2022to 30 Aug 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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.

Conditions
Weight Loss
Being tested
Community-based mentoring and education sessions
Medical subject headings
Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community-based mentoring and education sessionsBehavioural

    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.

Study groups in NCT05136339
Study groupRoleWhat they receive
Immediate Community-Based Mentoring and Education SessionsExperimentalSubjects will receive the intervention of community-based mentoring and education sessions immediately after enrollment.
Receives: Behavioral: Community-based mentoring and education sessions
Delayed Community-Based Mentoring and Education SessionsExperimentalSubjects will receive the intervention of community-based mentoring and education sessions approximately 12 months after enrollment.
Receives: Behavioral: Community-based mentoring and education sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Weight

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

    Measured: Baseline, 6 months, 12 months

  2. 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.

    Measured: Baseline, 6 months, 12 months

  3. 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).

    Measured: Baseline, 6 months, 12 months

  4. Lost >5% of Body Weight

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

    Measured: 6 months, 12 months

Secondary outcomes (6)

  1. Change in Systolic Blood Pressure

    Measured three times and the average of the second and third readings will be used in analyses, reported in mmHg. Change from baseline to 6 months and from baseline to 12 months.

    Measured: Baseline, 6 months, 12 months

  2. Change in Fasting Glucose Level

    6 hours fasting glucose blood serum level, reported in mg/dL. Baseline to 6 months and baseline to 12 months.

    Measured: Baseline, 6 months, 12 months

  3. Change in Low-density Lipoprotein (LDL)

    Change in LDL cholesterol blood serum level, reported in mg/dL. Baseline to 6 months and baseline to 12 months

    Measured: Baseline, 6 months, 12 months

  4. Change in Dietary Quality

    24-hour dietary recall collected using the Nutrition Data System for Research (NDSR) used to calculate the Healthy Eating index (HEI-2015). The HEI range is 0-100 with higher scores indicating healthier dietary quality. Scores can be further categorized as HEI≥69.3 optimal, HEI 56.9-69.2 intermediate, HEI<56.9 poor. Change from baseline to 6 months and baseline to 12 months.

    Measured: Baseline, 6 months, 12 months

  5. Change in Physical Activity

    Measured using the International Physical Activity Questionnaire (IPAQ) that assesses the number of minutes of mild, moderate, and vigorous physical activity over the previous 7 days, scores categorized as ≥150 min/wk moderate or ≥75 min/wk vigorous or ≥150 min/wk moderate+vigorous = optimal; 1-149 min/wk moderate or 1-74 min/wk vigorous or 1-149 min/wk moderate+vigorous = intermediate; no physical activity = poor. Baseline to 6 months and baseline to 12 months. For this study, we present IPAQ results as a continuous variable of MET minutes per week, which refers to the total amount of physical activity measured in Metabolic Equivalent of Task (MET) units over a week. Physical Activity Guidelines recommend achieving 500 to 1,000 MET minutes per week for significant health benefits.

    Measured: Baseline, 6 months, 12 months

  6. Change in Diastolic Blood Pressure

    Chage from baseline to 6 months and from baseline to 12 months (mmHg)

    Measured: Baseline, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2021
  2. Study start23 Apr 2022
  3. Primary completion30 Aug 2024
  4. Study completion30 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
475 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05136339
Sponsor's protocol ID
21-009339
Other IDs
P50MD017342-01
Status last verified
Jan 2026
First submitted
16 Nov 2021
Last updated
27 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wieland ML, Molina L, Goodson M, Porraz Capetillo G, Osman A, Ahmed Y, Nur O, Iteghete SO, Dirie H, Clark MM, Lohr AM, Njeru JW, Patten CA, Suarez Pardo L, Zeratsky K, Rieck T, Herrin J, Valente TW, Sia IG. Social network intervention for cardiovascular risk reduction among Hispanic and Somali adults: a cluster randomized trial. Ann Behav Med. 2026 Jan 7;60(1):kaag020. doi: 10.1093/abm/kaag020.

    PubMed 42847369

  • 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. 2026 Jun;28(3):603-611. doi: 10.1007/s10903-025-01812-9. Epub 2025 Dec 11.

    PubMed 41379348

  • 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.

    PubMed 40034444

  • 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.

    PubMed 39014369

  • 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.

    PubMed 38578534

  • 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.

    PubMed 38559259

Questions about this trial

What is this clinical trial studying?

A study testing Community-based mentoring and education sessions in people with Weight Loss, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight (time frame: Baseline, 6 months, 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05136339, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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