- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01912859
Next Steps: a Community-led Solution to Address Childhood Obesity
Next Steps: a Community-led Solution to Sustaining Healthy Behaviors in Families Addressing Childhood Obesity
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nutrition/physical activity intervention
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.
|
Nutrition/physical activity intervention
|
|
No Intervention: Usual care
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maintain or lower body mass index
Time Frame: up to 4 months
|
Body mass index.
|
up to 4 months
|
|
Frequency and intensity of physical activity
Time Frame: up to 4 months
|
Frequency and intensity of physical activity
|
up to 4 months
|
|
Frequency of intake of healthful foods and reduction of unhealthful foods;
Time Frame: up to 4 months
|
Frequency of intake of healthful foods and reduction of unhealthful foods;
|
up to 4 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chrisa Arcan, PhD, University of Minnesota
- Principal Investigator: John D Anderson, MD, Hennepin County Medical Center, Minneapolis
- Principal Investigator: Maria Galvan, Community Leader
- Principal Investigator: Natividad Contreras, Community Leader
- Principal Investigator: Aurolivia Reyes, Community Leader
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1303S29343
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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