NCT02135328

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

May 5, 2014

Last Update Submit

October 30, 2019

Conditions

Keywords

Type 2 diabetesDietary behaviorsPhysical activity behaviorsRadio story, entertainment health educationImmigrantsSomali, Latino, HmongFamilies with 3-18 year old children

Outcome Measures

Primary Outcomes (1)

  • 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.

    Intentions to change behavior from baseline to follow-up. After listening to radio story or audio brochure, an average of 25 minutes.

Study Arms (2)

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.

Behavioral: Radio Story

Audio brochure

ACTIVE COMPARATOR

Participants received an audio version of a standard brochure about type 2 diabetes prevention and management.

Behavioral: Audio brochure

Interventions

Radio StoryBEHAVIORAL

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.

Radio Story
Audio brochureBEHAVIORAL

The control participants listened to an adio version of a standard brochure about prevention and management of type 2 diabetes.

Audio brochure

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 9, 2014

Study Start

September 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 1, 2019

Record last verified: 2019-10