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Next Steps: a Community-led Solution to Address Childhood Obesity

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutrition/physical activity intervention
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Families that are graduates of the Taking Step Together program.
  • Families with at least one overweight or obese child between the ages of 7-17.
  • Family members of all ages who have graduated from the Taking Steps Together program will be included in the study.

Exclusion Criteria:

  • Families who are not graduates of the Taking Steps Together program.
  • Families who do not have one child that is between the ages of 7-17 and who is overweight or obese

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Nutrition/physical activity intervention

    Usual care

    Arm Description

    The intervention, Next Steps, comprises a network of community-led health maintenance programs offered to graduates of an initial intensive obesity course. These health maintenance programs will aim to help participants maintain and improve healthful behaviors and body mass indices.

    Participants in the "No Intervention" arm will not have access to the Next Steps programs and will receive only usual care through their health care clinic.

    Outcomes

    Primary Outcome Measures

    Maintain or lower body mass index
    Body mass index.
    Frequency and intensity of physical activity
    Frequency and intensity of physical activity
    Frequency of intake of healthful foods and reduction of unhealthful foods;
    Frequency of intake of healthful foods and reduction of unhealthful foods;

    Secondary Outcome Measures

    Full Information

    First Posted
    July 18, 2013
    Last Updated
    October 30, 2019
    Sponsor
    University of Minnesota
    Collaborators
    Hennepin County Medical Center, Minneapolis, The Family Partnership, Minneapolis, Community Leaders, Minneapolis, Richfield
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01912859
    Brief Title
    Next Steps: a Community-led Solution to Address Childhood Obesity
    Official Title
    Next Steps: a Community-led Solution to Sustaining Healthy Behaviors in Families Addressing Childhood Obesity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Minnesota
    Collaborators
    Hennepin County Medical Center, Minneapolis, The Family Partnership, Minneapolis, Community Leaders, Minneapolis, Richfield

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of Next Steps pilot intervention is to develop and test a new program designed to help low-income multiethnic families with overweight or obese children achieve long-term maintenance of healthful behaviors following completion of Hennepin County Medical Center's (HCMC) 16-week intensive obesity management course (Taking Steps Together (TST)).
    Detailed Description
    Next Steps is a community based pilot intervention study conducted in collaboration between community leaders, the University of Minnesota, Hennepin County Medical Center (HCMC) and The Family Partnership. The study collaborators will develop and test a new program designed to help low-income multiethnic families with overweight or obese children achieve long-term maintenance of healthful behaviors following completion of HCMC's 16-week intensive obesity management course (Taking Steps Together (TST)). Next Steps, the focus of this study, will comprise a network of parent-led, community-based health maintenance programs that will be offered to TST graduate families. Project Aims: Aim 1: Establish a core parent leadership group and health maintenance program network that is self-sustaining and can serve the community for years to come. Aim 2: Test the feasibility, acceptability and sustainability of the Next Steps programs. Aim 3: Assess the impact of the Next Steps programs on helping participant families sustain or improve healthful behaviors and achieve or maintain healthy body mass index (BMI).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nutrition/physical activity intervention
    Arm Type
    Experimental
    Arm Description
    The intervention, Next Steps, comprises a network of community-led health maintenance programs offered to graduates of an initial intensive obesity course. These health maintenance programs will aim to help participants maintain and improve healthful behaviors and body mass indices.
    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    Participants in the "No Intervention" arm will not have access to the Next Steps programs and will receive only usual care through their health care clinic.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Nutrition/physical activity intervention
    Intervention Description
    Nutrition/physical activity intervention
    Primary Outcome Measure Information:
    Title
    Maintain or lower body mass index
    Description
    Body mass index.
    Time Frame
    up to 4 months
    Title
    Frequency and intensity of physical activity
    Description
    Frequency and intensity of physical activity
    Time Frame
    up to 4 months
    Title
    Frequency of intake of healthful foods and reduction of unhealthful foods;
    Description
    Frequency of intake of healthful foods and reduction of unhealthful foods;
    Time Frame
    up to 4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Families that are graduates of the Taking Step Together program. Families with at least one overweight or obese child between the ages of 7-17. Family members of all ages who have graduated from the Taking Steps Together program will be included in the study. Exclusion Criteria: Families who are not graduates of the Taking Steps Together program. Families who do not have one child that is between the ages of 7-17 and who is overweight or obese
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chrisa Arcan, PhD
    Organizational Affiliation
    University of Minnesota
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    John D Anderson, MD
    Organizational Affiliation
    Hennepin County Medical Center, Minneapolis
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Maria Galvan
    Organizational Affiliation
    Community Leader
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Natividad Contreras
    Organizational Affiliation
    Community Leader
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Aurolivia Reyes
    Organizational Affiliation
    Community Leader
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Next Steps: a Community-led Solution to Address Childhood Obesity

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