NCT01912859

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)).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable obesity

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

July 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

July 18, 2013

Last Update Submit

October 30, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Maintain or lower body mass index

    Body mass index.

    up to 4 months

  • Frequency and intensity of physical activity

    Frequency and intensity of physical activity

    up to 4 months

  • Frequency of intake of healthful foods and reduction of unhealthful foods;

    Frequency of intake of healthful foods and reduction of unhealthful foods;

    up to 4 months

Study Arms (2)

Nutrition/physical activity intervention

EXPERIMENTAL

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.

Behavioral: Nutrition/physical activity intervention

Usual care

NO INTERVENTION

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.

Interventions

Nutrition/physical activity intervention

Nutrition/physical activity intervention

Eligibility Criteria

Age2 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2013

First Posted

July 31, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 1, 2019

Record last verified: 2019-10