Healthy Immigrant Families: Working Together To Move More and To Eat Well

NCT ID: NCT01952808

Last Updated: 2017-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-05-31

Brief Summary

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This project will broadly explore the efficacy of community participation in the design and implementation of an intervention to improve physical activity and nutrition among immigrant and refugee (Hispanic, Somali, Sudanese, Cambodian) families in Rochester, Minnesota

Detailed Description

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Conditions

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Immigrant Physical Activity and Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention Group

Participants randomly assigned to this group will receive the intervention immediately.

Group Type EXPERIMENTAL

Face-to-face family mentoring and education sessions

Intervention Type BEHAVIORAL

A total of 13 home visits will be completed over a 6 month period. In addition to an introductory/orientation visit, 12 home visits will consist of family mentoring/educational sessions focused on physical activity and healthy nutrition.

Telephone follow-up

Intervention Type BEHAVIORAL

During months 7-12, a total of up to 12 phone calls will be completed. Follow-up calls will consist of a progress report from families on physical activity and healthy diet progress/goals, along with brief content follow-up and re-enforcement points from the 12 intervention sessions.

Control Group

Participants randomly assigned to this group will not receive the intervention until one year after enrollment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Face-to-face family mentoring and education sessions

A total of 13 home visits will be completed over a 6 month period. In addition to an introductory/orientation visit, 12 home visits will consist of family mentoring/educational sessions focused on physical activity and healthy nutrition.

Intervention Type BEHAVIORAL

Telephone follow-up

During months 7-12, a total of up to 12 phone calls will be completed. Follow-up calls will consist of a progress report from families on physical activity and healthy diet progress/goals, along with brief content follow-up and re-enforcement points from the 12 intervention sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Minimum age of 11 years old
* Reside in a household with at least one adult and one child (11-18)
* Not planning to move from the area over the next two years
* Willing and able to participate in all aspects of the study
* Willingness to provide oral informed consent
* Hispanic, Sudanese, Somali
* Residing in Rochester, MN

Exclusion Criteria

* Self-reported pregnancy
* Self-reported insulin-dependent diabetes
* Self-reported diagnosis of cancer within the past 3 years
* Answer of "yes" to the following question: "Do you know of any reason why you should not do physical activity? For example, would it be unsafe for you to do increased physical activity because of a health problem?"
Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Irene G. Sia, M.D.

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irene Sia, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Wieland ML, Weis JA, Hanza MM, Meiers SJ, Patten CA, Clark MM, Sloan JA, Novotny PJ, Njeru JW, Abbenyi A, Levine JA, Goodson M, Porraz Capetillo MG, Osman A, Hared A, Nigon JA, Sia IG. Healthy immigrant families: Participatory development and baseline characteristics of a community-based physical activity and nutrition intervention. Contemp Clin Trials. 2016 Mar;47:22-31. doi: 10.1016/j.cct.2015.12.004. Epub 2015 Dec 4.

Reference Type DERIVED
PMID: 26655431 (View on PubMed)

Other Identifiers

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13-003408

Identifier Type: -

Identifier Source: org_study_id

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