B'More Healthy; Communities for Kids (BHCK) (BHCK)

October 5, 2022 updated by: Johns Hopkins Bloomberg School of Public Health

B'More Healthy: Communities for Kids (BHCK)

The BHCK study will develop, implement, and evaluate a community-based obesity prevention program, which operates at multiple levels of an urban food system (policy, wholesaler, corner stores, carryout, household, individual; in Baltimore, MD), and will improve the healthy food supply chain to increase affordability, availability, purchasing and consumption of healthy foods within low-income, minority neighborhoods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our overarching goal is to develop and evaluate a community-based obesity prevention program, which operates at multiple levels of an urban food system (policy, wholesaler, corner stores, carryout, household, individual; in Baltimore, MD), and will improve the healthy food supply chain to increase affordability, availability, purchasing and consumption of healthy foods within low-income minority neighborhoods. Our research will include stakeholders/ partners at different levels, e.g., the policy, wholesaler, retailer, adult caregiver, and individual child levels, and then develop, implement, and assess a two year multi-level systems-based child obesity prevention strategy targeting minority and low-income children (predominantly AA). Thirty low-income, predominantly AA geographic zones will be identified ("healthy eating zones"). Half of these zones will be randomized to intervention, while the other half will be control. Within each intervention zone we will work with 3-5 small food stores and prepared food sources to increase access to healthy foods through wholesaler discounts, display point of purchase promotional materials, and provide nutrition and food preparation education targeting youth and caregivers. We will work with local policymakers to institutionalize and sustain these changes.

The project will evaluate the impact of the program on: a) healthy food pricing and availability, b) low income African American adult food purchasing and preparation, and c) low-income African American youth diet, and associated psychosocial factors.

Study Type

Interventional

Enrollment (Anticipated)

890

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University

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

9 years to 100 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria for Child participants:

9-14 years of age Living within one of the intervention neighborhoods Family does not anticipate moving outside of the study area during the duration of intervention

Inclusion Criteria for Adult Caregiver participants:

Parent/ legal guardian of a child ages 9-14 years of age Living within one of the intervention neighborhoods Family does not anticipate moving outside of the study area during the duration of intervention

Exclusion criteria:

Families that do not have a child within the age range Families that do not live within the neighborhoods in the study area Families who will move outside the study area within the intervention timeframe

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The intervention is a multi-level, multi-component intervention designed to increase access to and consumption of healthier foods in low-income, urban, minority neighborhoods. Intervention components will occur at the policy level; food wholesaler level; small food retail outlet level; neighborhood level; household level.
Behavioral: Intervention
Intervention components will occur at the policy level (working within Baltimore City policy makers to sustain intervention components, and develop virtual simulations of the Baltimore food environment); food wholesaler level (working with wholesalers to stock healthier food items and provide pricing incentives to storeowners on healthier foods); small food retail outlet level (working with corner store and carry-out owners to stock, promote, and sell healthier foods and beverages); neighborhood level (working with Baltimore college students to deliver nutrition intervention sessions to younger youth in recreation centers in intervention neighborhoods); household level (providing a text messaging and social media program that provides parents and caregivers tips for healthier eating in their respective neighborhoods).
No Intervention: Control
Similar to many community- based public health research programs, the control arm will not receive any intervention components during the initial intervention period. However, after all assessments are completed they will receive a 'delayed intervention' protocol, where the community receives the intervention elements as described in the intervention arm after assessment measures have been completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Small Retail Food Store - Healthy Food Availability
Time Frame: Up to 4 years
A food environment checklist (a modified from the NEMS questionnaire) will be conducted before and after the intervention to assess healthy food availability in both intervention and comparison neighborhoods/ stores.
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Household Healthy Food Purchasing
Time Frame: Up to 4 years
At the adult consumer level, we will use an Adult Impact Questionnaire to examine trends in frequency of purchasing of specific promoted foods pre- and post-intervention. We will score the questionnaire to look at individual food items, as well as at changes in groups of foods developed previously (e.g., healthy and unhealthy food scores, and based on Healthy Eating Index categories).
Up to 4 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary intake of urban, African American youth participants (specifically total calories and fat consumption.)
Time Frame: Up to 4 years
We will use the Block 2004 Kids Food Frequency questionnaire to assess differences in dietary intake from pre- to post intervention. Data from the FFQ will include total caloric intake and fat intake, along wit other dietary markers.
Up to 4 years

Collaborators and Investigators

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

Sponsor

Johns Hopkins Bloomberg School of Public Health

Investigators

  • Principal Investigator: Joel Gittelsohn, PhD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

January 1, 2012

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

June 20, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimate)

July 3, 2014

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111189

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.

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