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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02181010
Recruitment Status : Unknown
Verified July 2014 by Joel Gittelsohn, Johns Hopkins Bloomberg School of Public Health.
Recruitment status was:  Recruiting
First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
Joel Gittelsohn, Johns Hopkins Bloomberg School of Public Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 890 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: B'More Healthy: Communities for Kids (BHCK)
Study Start Date : January 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2018

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181010


Contacts
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Contact: Joel Gittelsohn, PhD 410-955-3927

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Joel Gittelsohn, PhD    410-955-3927    jgittel1@jhu.edu   
Principal Investigator: Joel Gittelsohn, PhD         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
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Principal Investigator: Joel Gittelsohn, PhD Johns Hopkins Bloomberg School of Public Health
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joel Gittelsohn, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02181010    
Other Study ID Numbers: 111189
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2014
Keywords provided by Joel Gittelsohn, Johns Hopkins Bloomberg School of Public Health:
African American
Adolescents
Urban
Food Desert
Food Insecurity
Obesity
Baltimore City
Peer mentors
Multi level
Policy
Caregivers
Systems
Agent Based Model
Systems Dynamic Model
Corner Store
Carryout
Recreation Center
Text Messaging
Social Media
Mapping
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight