NCT03111680

Brief Summary

This is a cluster randomized study of an environmental level intervention to improve nutrition and physical activity, among public housing residents. Followup was one year post baseline

Trial Health

87
On Track

Trial Health Score

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

Enrollment
211

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

April 4, 2017

Last Update Submit

April 12, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • healthy eating

    fruit and vegetable servings per day

    in the last three months

  • healthy physical activity

    time spent doing moderate physcial activity

    in the last three months

Study Arms (2)

intervention

EXPERIMENTAL

this arm received an environmental intervention to make healthy eating and activity easier for residents

Other: environmental intervention

control

NO INTERVENTION

the control participants received no interventions

Interventions

environmental interventionOTHER

a multi component environmental intervention

intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • residing in public housing able to read spanish or english mother of a child aged 6-17

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Quintiliani LM, DeBiasse MA, Branco JM, Bhosrekar SG, Rorie JA, Bowen DJ. Enhancing physical and social environments to reduce obesity among public housing residents: rationale, trial design, and baseline data for the Healthy Families study. Contemp Clin Trials. 2014 Nov;39(2):201-10. doi: 10.1016/j.cct.2014.08.005. Epub 2014 Aug 17.

    PMID: 25139728BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Milieu Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
people collecting data were unaware of study condition
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: this was a cluster randomized trial, with housing developments randomized to intervention or control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 13, 2017

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2016

Last Updated

April 14, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)