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OpenTrials
Completed

NCT Number: NCT01952808

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

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

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Key information

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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?"

Treatment and study plan

Face-to-face family mentoring and education sessions

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

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.

Primary outcomes

  1. Improved dietary quality

    Time frame: Baseline- 24 months

    A 24-hour dietary recall will be collected in-person from study participants at baseline and follow-up using the Automated Self-administered 24-hour Recall (ASA24) system.

  2. Increased physical activity

    Time frame: Baseline- 24 months

    The KAM (Kinetic Activity Monitor) accelerometer will be used for objective physical activity assessment.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Sep 30, 2013
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.