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
About this trial
This is an interventional treatment trial for Obesity
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
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
NCT ID
NCT01912859
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
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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