ObesityNCT01912859
Next Steps: a Community-led Solution to Address Childhood Obesity
A study testing Nutrition/physical activity intervention in people with Obesity, run by University of Minnesota.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Nutrition/physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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)).
Read the 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).
- Conditions
- Obesity
- Being tested
- Nutrition/physical activity intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition/physical activity interventionBehavioural
Nutrition/physical activity intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintain or lower body mass index
Body mass index.
Measured: up to 4 months
Frequency and intensity of physical activity
Frequency and intensity of physical activity
Measured: 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;
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Hennepin County Medical Center, Minneapolis, The Family Partnership, Minneapolis, Community Leaders, Minneapolis, Richfield
- Responsible party
- Sponsor
- Investigators
- Chrisa Arcan, PhD, Principal investigator, University of MinnesotaJohn D Anderson, MD, Principal investigator, Hennepin County Medical Center, MinneapolisMaria Galvan, Principal investigator, Community LeaderNatividad Contreras, Principal investigator, Community LeaderAurolivia Reyes, Principal investigator, Community Leader
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912859
- Sponsor's protocol ID
- 1303S29343
- Status last verified
- Oct 2019
- First submitted
- 18 Jul 2013
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next Steps: a Community-led Solution to Sustaining Healthy Behaviors in Families Addressing Childhood Obesity
- ClinicalTrials.gov ID
- NCT01912859
- Acronym / sponsor ID
- 1303S29343
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Hennepin County Medical Center, Minneapolis, The Family Partnership, Minneapolis, Community Leaders, Minneapolis, Richfield
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition/physical activity intervention | Experimental | Behavioral: Nutrition/physical activity interventionThe 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. |
| 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. |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition/physical activity interventionNutrition/physical activity intervention | Behavioural | Nutrition/physical activity intervention |
Primary outcome
Maintain or lower body mass index
Time frame: up to 4 months
Body mass index.
Frequency and intensity of physical activity
Time frame: up to 4 months
Frequency and intensity of physical activity
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;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chrisa Arcan, PhD principal investigator
University of Minnesota
John D Anderson, MD principal investigator
Hennepin County Medical Center, Minneapolis
Maria Galvan principal investigator
Community Leader
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition/physical activity intervention in people with Obesity, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintain or lower body mass index (time frame: up to 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.