Type 2 DiabetesNCT02135328
SoLaHmo Radio Stories About Children's Healthy Eating and Exercise
A study testing Radio Story and Audio brochure in people with Type 2 Diabetes, run by University of Minnesota.
Trial summary
The purpose of this study is to use a community based participatory action research (CBPAR) approach to 1) create "radio stories" about Somali, Latino and Hmong families' real success stories with type 2 diabetes mellitus (DM) in managing their disease through implementation of healthful lifestyle behaviors (nutrition… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Radio Story and Audio brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Aug 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Family self-identifies as Somali, Latino or Hmong
- Family has at least one child between the ages of 3-18 years old
- English or Spanish or Somali or Hmong speaking
- Family identified as having a compelling story with childhood obesity or Type 2 diabetes prevention
- Inclusion Criteria for Intervention and Control Group Participants:
- Self-identified member of Somali, Latino or Hmong communities
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- Adult age 18 years and older
- English or Spanish or Somali or Hmong-speaking
- Parent/caregiver is involved with raising children between the ages of 3-18 years
Who cannot join
- Family does not self-identify as Somali, Latino or Hmong
- Family does not have children between the ages of 3-18 years
- Not English or Spanish or Somali or Hmong speaking
- Parent/caregiver Is not involved with raising children between the ages of 3-18 years
- Exclusion criteria for Intervention and Control Group Participants:
- Participants do not self-identify as Somali, Latino or Hmong
Show all 9Show fewer
- Participants are younger than 18 years
- Participants are not caregivers of children between the ages of 3-18 years
- Not English or Spanish or Somali or Hmong speaking
About this study
Official title: Somali, Latino & Hmong Radio Stories About Children's Healthy Eating and Exercise: A SoLaHmo Pilot Study
The purpose of this study is to use a community based participatory action research (CBPAR) approach to 1) create "radio stories" about Somali, Latino and Hmong families' real success stories with type 2 diabetes mellitus (DM) in managing their disease through implementation of healthful lifestyle behaviors (nutrition and physical activity), and 2) test the effectiveness and acceptability of radio stories on participant intentions to engage in or improve healthful lifestyle behaviors. Participants in the Intervention condition listened to the "radio stories" and the participants in the control condition listened to an audio brochure with relevant information. We hypothesized that the intervention participants would report higher intensions to engage in various healthful lifestyle behaviors than the control participants after both participants listened to their respective health information.
Read the detailed description
Given the high rate of type 2 diabetes mellitus (diabetes) in minority and immigrant communities, implementing culturally and linguistically appropriate health promotion activities that improve families' diet and physical activity behaviors is imperative. "Radio Stories" is an education entertainment strategy that has significant potential as a health promotion tool. Through a CBPAR process, we aimed to create and test the effectiveness and acceptability of "SoLaHmo Radio Stories" about changing knowledge and behaviors to prevent or manage diabetes for Somali, Latino, and Hmong families.
Methods: SoLaHmo community researchers interview 3 families (1 Somali, 1 Latino, and 1 Hmong) who have successfully implemented lifestyle changes to prevent or manage diabetes, and then create 3 "radio stories" based on the families' experiences. To test the stories, we are conducting a two-arm trial that includes intervention groups (20 people per community) that listen to the radio stories and control groups (20 people per community) that receive a brochure with similar information (N=120). Effectiveness and acceptability of the program will be tested with pre-and post questionnaires.
Anticipated Results: Higher rates of satisfaction, increased knowledge, and intention to change in participants receiving the radio stories, as compared to control group participants, will indicate radio story program effectiveness and acceptability.
- Conditions
- Type 2 Diabetes
- Being tested
- Radio Story, Audio brochure
- Keywords
- Type 2 diabetes, Dietary behaviors, Physical activity behaviors, Radio story, entertainment health education, Immigrants, Somali, Latino, Hmong, Families with 3-18 year old children
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio StoryBehavioural
For the purposes of this study a "Radio Story" is an audio recorded story of about a family's success story about type 2 diabetes mellitus prevention and management.
Audio brochureBehavioural
The control participants listened to an adio version of a standard brochure about prevention and management of type 2 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Radio Story | Experimental | Participants listen to a radio story about a family's' success with preventing or managing type 2 diabetes through diet and physical activity; the focus was for the entire family to implement healthful lifestyle behaviors so the children can learn as well. Receives: Behavioral: Radio Story |
| Audio brochure | Active comparator | Participants received an audio version of a standard brochure about type 2 diabetes prevention and management. Receives: Behavioral: Audio brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and effectiveness of radio stories, a health communication intervention that addresses family eating behaviors and physical activity among immigrant Somali, Latino, and Hmong families
The baseline and follow-up survey questions to test the "radio stories" included 15 items referring to intentions to change or improve a specific diet, physical activity, and health related behavior. There were four Likert scale response categories, from 'strongly disagree' to 'strongly agree.' In addition, the follow-up survey included questions to assess participant perceptions of the radio stories relating to their emotional connection to the story, relevance with their own experience, believability, and increase awareness and concern about type 2 diabetes.
Measured: Intentions to change behavior from baseline to follow-up. After listening to radio story or audio brochure, an average of 25 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- West Side Community Health Services
- Responsible party
- Sponsor
- Investigators
- Chrisa Arcan, Ph.D., Principal investigator, University of MinnesotaShannon L Pergament, MPH, MSW, Principal investigator, West Side Community Health Services/SoLaHmo Partnership for Health and Wellness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135328
- Sponsor's protocol ID
- 1209S19821
- Status last verified
- Oct 2019
- First submitted
- 5 May 2014
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somali, Latino & Hmong Radio Stories About Children's Healthy Eating and Exercise: A SoLaHmo Pilot Study
- ClinicalTrials.gov ID
- NCT02135328
- Acronym / sponsor ID
- 1209S19821
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Dietary behaviors, Physical activity behaviors, Radio story, entertainment health education, Immigrants, Somali, Latino, Hmong, Families with 3-18 year old children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- West Side Community Health Services
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 May 2014 (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.
The purpose of this study is to use a community based participatory action research (CBPAR) approach to 1) create "radio stories" about Somali, Latino and Hmong families' real success stories with type 2 diabetes mellitus (DM) in managing their disease through implementation of healthful lifestyle behaviors (nutrition and physical activity), and 2) test the effectiveness and acceptability of radio stories on participant intentions to engage in or improve healthful lifestyle behaviors. Participants in the Intervention condition listened to the "radio stories" and the participants in the control condition listened to an audio brochure with relevant information. We hypothesized that the intervention participants would report higher intensions to engage in various healthful lifestyle behaviors than the control participants after both participants listened to their respective health information.
Detailed description
Given the high rate of type 2 diabetes mellitus (diabetes) in minority and immigrant communities, implementing culturally and linguistically appropriate health promotion activities that improve families' diet and physical activity behaviors is imperative. "Radio Stories" is an education entertainment strategy that has significant potential as a health promotion tool. Through a CBPAR process, we aimed to create and test the effectiveness and acceptability of "SoLaHmo Radio Stories" about changing knowledge and behaviors to prevent or manage diabetes for Somali, Latino, and Hmong families.
Methods: SoLaHmo community researchers interview 3 families (1 Somali, 1 Latino, and 1 Hmong) who have successfully implemented lifestyle changes to prevent or manage diabetes, and then create 3 "radio stories" based on the families' experiences. To test the stories, we are conducting a two-arm trial that includes intervention groups (20 people per community) that listen to the radio stories and control groups (20 people per community) that receive a brochure with similar information (N=120). Effectiveness and acceptability of the program will be tested with pre-and post questionnaires.
Anticipated Results: Higher rates of satisfaction, increased knowledge, and intention to change in participants receiving the radio stories, as compared to control group participants, will indicate radio story program effectiveness and acceptability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radio Story | Experimental | Behavioral: Radio StoryParticipants listen to a radio story about a family's' success with preventing or managing type 2 diabetes through diet and physical activity; the focus was for the entire family to implement healthful lifestyle behaviors so the children can learn as well. |
| Audio brochure | Active comparator | Behavioral: Audio brochureParticipants received an audio version of a standard brochure about type 2 diabetes prevention and management. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Family self-identifies as Somali, Latino or Hmong
- Family has at least one child between the ages of 3-18 years old
- English or Spanish or Somali or Hmong speaking
- Family identified as having a compelling story with childhood obesity or Type 2 diabetes prevention
- Self-identified member of Somali, Latino or Hmong communities
Key exclusion criteria (9 listed)
- Family does not self-identify as Somali, Latino or Hmong
- Family does not have children between the ages of 3-18 years
- Not English or Spanish or Somali or Hmong speaking
- Parent/caregiver Is not involved with raising children between the ages of 3-18 years
- Participants do not self-identify as Somali, Latino or Hmong
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 |
|---|---|---|
| Radio StoryFor the purposes of this study a "Radio Story" is an audio recorded story of about a family's success story about type 2 diabetes mellitus prevention and management. | Behavioural | Radio Story |
| Audio brochureThe control participants listened to an adio version of a standard brochure about prevention and management of type 2 diabetes. | Behavioural | Audio brochure |
Primary outcome
Acceptability and effectiveness of radio stories, a health communication intervention that addresses family eating behaviors and physical activity among immigrant Somali, Latino, and Hmong families
Time frame: Intentions to change behavior from baseline to follow-up. After listening to radio story or audio brochure, an average of 25 minutes.
The baseline and follow-up survey questions to test the "radio stories" included 15 items referring to intentions to change or improve a specific diet, physical activity, and health related behavior. There were four Likert scale response categories, from 'strongly disagree' to 'strongly agree.' In addition, the follow-up survey included questions to assess participant perceptions of the radio stories relating to their emotional connection to the story, relevance with their own experience, believability, and increase awareness and concern about type 2 diabetes.
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 1 Nov 2019.
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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.
Chrisa Arcan, Ph.D. principal investigator
University of Minnesota
Shannon L Pergament, MPH, MSW principal investigator
West Side Community Health Services/SoLaHmo Partnership for Health and Wellness
Questions about this trial
What is this clinical trial studying?
A study testing Radio Story and Audio brochure in people with Type 2 Diabetes, run by University of Minnesota.
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 9 inclusion and 9 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Acceptability and effectiveness of radio stories, a health communication intervention that addresses family eating behaviors and physical activity among immigrant Somali, Latino, and Hmong families (time frame: Intentions to change behavior from baseline to follow-up. After listening to radio story or audio brochure, an average of 25 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2019.