Immigrant Physical Activity and NutritionNCT01952808
Healthy Immigrant Families: Working Together To Move More and To Eat Well
A study testing Face-to-face family mentoring and education sessions and Telephone follow-up in people with Immigrant Physical Activity and Nutrition, run by Mayo Clinic at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immigrant Physical Activity and Nutrition
- What is being tested?
- Face-to-face family mentoring and education sessions and Telephone follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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?"
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
- Being tested
- Face-to-face family mentoring and education sessions, Telephone follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face family mentoring and education sessionsBehavioural
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-upBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants randomly assigned to this group will receive the intervention immediately. Receives: Behavioral: Face-to-face family mentoring and education sessions; Behavioral: Telephone follow-up |
| Control Group | No intervention | Participants randomly assigned to this group will not receive the intervention until one year after enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved dietary quality
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.
Measured: Baseline- 24 months
Increased physical activity
The KAM (Kinetic Activity Monitor) accelerometer will be used for objective physical activity assessment.
Measured: Baseline- 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immigrant Physical Activity and NutritionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene G. Sia, M.D., Mayo Clinic
- Investigators
- Irene Sia, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952808
- Sponsor's protocol ID
- 13-003408
- Status last verified
- Mar 2017
- First submitted
- 24 Sep 2013
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26655431
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Immigrant Families: Working Together To Move More and To Eat Well
- ClinicalTrials.gov ID
- NCT01952808
- Acronym / sponsor ID
- 13-003408
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Face-to-face family mentoring and education sessions, Behavioral: Telephone follow-upParticipants randomly assigned to this group will receive the intervention immediately. |
| Control Group | No intervention | –Participants randomly assigned to this group will not receive the intervention until one year after enrollment. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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?"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-to-face family mentoring and education sessionsA 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. | Behavioural | Intervention Group |
| Telephone follow-upDuring 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. | Behavioural | Intervention Group |
Primary outcome
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.
Increased physical activity
Time frame: Baseline- 24 months
The KAM (Kinetic Activity Monitor) accelerometer will be used for objective physical activity assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Derived from this study: PubMed 26655431Wieland 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Sia, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face family mentoring and education sessions and Telephone follow-up in people with Immigrant Physical Activity and Nutrition, 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 7 inclusion and 4 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 22 Mar 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improved dietary quality (time frame: Baseline- 24 months). The study lists 2 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 NCT01952808, which also lists 1 linked publication.
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 22 Mar 2017.