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

October 30, 2019 updated by: University of Minnesota

Next Steps: a Community-led Solution to Sustaining Healthy Behaviors in Families Addressing Childhood Obesity

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)).

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (Estimate)

July 31, 2013

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

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.

Clinical Trials on Obesity

Clinical Trials on Nutrition/physical activity intervention

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