- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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
|
Ingen indgriben: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Maintain or lower body mass index
Tidsramme: up to 4 months
|
Body mass index.
|
up to 4 months
|
Frequency and intensity of physical activity
Tidsramme: 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;
Tidsramme: up to 4 months
|
Frequency of intake of healthful foods and reduction of unhealthful foods;
|
up to 4 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Chrisa Arcan, PhD, University of Minnesota
- Ledende efterforsker: John D Anderson, MD, Hennepin County Medical Center, Minneapolis
- Ledende efterforsker: Maria Galvan, Community Leader
- Ledende efterforsker: Natividad Contreras, Community Leader
- Ledende efterforsker: Aurolivia Reyes, Community Leader
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1303S29343
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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