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SoLaHmo Radio Stories About Children's Healthy Eating and Exercise

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ClinicalTrials.gov Identifier: NCT02135328
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : November 1, 2019
Sponsor:
Collaborator:
West Side Community Health Services
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE May 5, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date November 1, 2019
Study Start Date  ICMJE September 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SoLaHmo Radio Stories About Children's Healthy Eating and Exercise
Official Title  ICMJE Somali, Latino & Hmong Radio Stories About Children's Healthy Eating and Exercise: A SoLaHmo Pilot Study
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Behavioral: Radio Story
    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.
  • Behavioral: Audio brochure
    The control participants listened to an adio version of a standard brochure about prevention and management of type 2 diabetes.
Study Arms  ICMJE
  • Experimental: Radio Story
    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.
    Intervention: Behavioral: Radio Story
  • Active Comparator: Audio brochure
    Participants received an audio version of a standard brochure about type 2 diabetes prevention and management.
    Intervention: Behavioral: Audio brochure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2014)
123
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for Key Family Informant Interviews:

  • 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
  • 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

Exclusion Criteria for Key Family Informant Interviews:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135328
Other Study ID Numbers  ICMJE 1209S19821
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE West Side Community Health Services
Investigators  ICMJE
Principal Investigator: Chrisa Arcan, Ph.D. University of Minnesota
Principal Investigator: Shannon L Pergament, MPH, MSW West Side Community Health Services/SoLaHmo Partnership for Health and Wellness
PRS Account University of Minnesota
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP