NCT02181010

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
890

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable obesity

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, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 3, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

5.9 years

First QC Date

June 20, 2014

Last Update Submit

October 5, 2022

Conditions

Keywords

African AmericanAdolescentsUrbanFood DesertFood InsecurityObesityBaltimore CityPeer mentorsMulti levelPolicyCaregiversSystemsAgent Based ModelSystems Dynamic ModelCorner StoreCarryoutRecreation CenterText MessagingSocial MediaMapping

Outcome Measures

Primary Outcomes (1)

  • Small Retail Food Store - Healthy Food Availability

    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 Outcomes (1)

  • Household Healthy Food Purchasing

    Up to 4 years

Other Outcomes (1)

  • Dietary intake of urban, African American youth participants (specifically total calories and fat consumption.)

    Up to 4 years

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

InterventionBEHAVIORAL

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).

Intervention

Eligibility Criteria

Age9 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (15)

  • Coakley HL, Steeves EA, Jones-Smith JC, Hopkins L, Braunstein N, Mui Y, Gittelsohn J. Combining Ground-Truthing and Technology to Improve Accuracy in Establishing Children's Food Purchasing Behaviors. J Hunger Environ Nutr. 2014;9(3):418-430. doi: 10.1080/19320248.2014.898173.

    PMID: 25729465BACKGROUND
  • Gittelsohn J, Anderson Steeves E, Mui Y, Kharmats AY, Hopkins LC, Dennis D. B'More Healthy Communities for Kids: design of a multi-level intervention for obesity prevention for low-income African American children. BMC Public Health. 2014 Sep 11;14:942. doi: 10.1186/1471-2458-14-942.

    PMID: 25209072BACKGROUND
  • Anderson Steeves E, Martins PA, Gittelsohn J. Changing the Food Environment for Obesity Prevention: Key Gaps and Future Directions. Curr Obes Rep. 2014 Dec;3(4):451-8. doi: 10.1007/s13679-014-0120-0.

    PMID: 25574452BACKGROUND
  • Gudzune KA, Welsh C, Lane E, Chissell Z, Anderson Steeves E, Gittelsohn J. Increasing access to fresh produce by pairing urban farms with corner stores: a case study in a low-income urban setting. Public Health Nutr. 2015 Oct;18(15):2770-4. doi: 10.1017/S1368980015000051. Epub 2015 Feb 4.

    PMID: 25649045BACKGROUND
  • Gittelsohn J, Mui Y, Adam A, Lin S, Kharmats A, Igusa T, Lee BY. Incorporating Systems Science Principles into the Development of Obesity Prevention Interventions: Principles, Benefits, and Challenges. Curr Obes Rep. 2015 Jun;4(2):174-81. doi: 10.1007/s13679-015-0147-x.

    PMID: 26069864BACKGROUND
  • Sattler M, Hopkins L, Anderson Steeves E, Cristello A, Mccloskey M, Gittelsohn J, Hurley K. Characteristics of Youth Food Preparation in Low-Income, African American Homes: Associations with Healthy Eating Index Scores. Ecol Food Nutr. 2015;54(4):380-96. doi: 10.1080/03670244.2014.1001982. Epub 2015 Feb 23.

    PMID: 25706350BACKGROUND
  • Vedovato GM, Surkan PJ, Jones-Smith J, Steeves EA, Han E, Trude AC, Kharmats AY, Gittelsohn J. Food insecurity, overweight and obesity among low-income African-American families in Baltimore City: associations with food-related perceptions. Public Health Nutr. 2016 Jun;19(8):1405-16. doi: 10.1017/S1368980015002888. Epub 2015 Oct 6.

    PMID: 26441159BACKGROUND
  • Anderson Steeves E, Jones-Smith J, Hopkins L, Gittelsohn J. Perceived Social Support From Friends and Parents for Eating Behavior and Diet Quality Among Low-Income, Urban, Minority Youth. J Nutr Educ Behav. 2016 May;48(5):304-310.e1. doi: 10.1016/j.jneb.2015.12.014. Epub 2016 Feb 8.

    PMID: 26865358BACKGROUND
  • Gittelsohn J, Trude A. Environmental Interventions for Obesity and Chronic Disease Prevention. J Nutr Sci Vitaminol (Tokyo). 2015;61 Suppl(Suppl):S15-6. doi: 10.3177/jnsv.61.S15.

    PMID: 26598834BACKGROUND
  • Mui Y, Lee BY, Adam A, Kharmats AY, Budd N, Nau C, Gittelsohn J. Healthy versus Unhealthy Suppliers in Food Desert Neighborhoods: A Network Analysis of Corner Stores' Food Supplier Networks. Int J Environ Res Public Health. 2015 Nov 30;12(12):15058-74. doi: 10.3390/ijerph121214965.

    PMID: 26633434BACKGROUND
  • Wong MS, Nau C, Kharmats AY, Vedovato GM, Cheskin LJ, Gittelsohn J, Lee BY. Using a computational model to quantify the potential impact of changing the placement of healthy beverages in stores as an intervention to "Nudge" adolescent behavior choice. BMC Public Health. 2015 Dec 23;15:1284. doi: 10.1186/s12889-015-2626-0.

    PMID: 26700158BACKGROUND
  • Sato PM, Steeves EA, Carnell S, Cheskin LJ, Trude AC, Shipley C, Mejia Ruiz MJ, Gittelsohn J. A youth mentor-led nutritional intervention in urban recreation centers: a promising strategy for childhood obesity prevention in low-income neighborhoods. Health Educ Res. 2016 Apr;31(2):195-206. doi: 10.1093/her/cyw011. Epub 2016 Mar 2.

    PMID: 26936480BACKGROUND
  • Ewart-Pierce E, Mejia Ruiz MJ, Gittelsohn J. "Whole-of-Community" Obesity Prevention: A Review of Challenges and Opportunities in Multilevel, Multicomponent Interventions. Curr Obes Rep. 2016 Sep;5(3):361-74. doi: 10.1007/s13679-016-0226-7.

    PMID: 27379620BACKGROUND
  • Trude ACB, Surkan PJ, Cheskin LJ, Gittelsohn J. A multilevel, multicomponent childhood obesity prevention group-randomized controlled trial improves healthier food purchasing and reduces sweet-snack consumption among low-income African-American youth. Nutr J. 2018 Oct 29;17(1):96. doi: 10.1186/s12937-018-0406-2.

  • Trude ACB, Kharmats AY, Jones-Smith JC, Gittelsohn J. Exposure to a multi-level multi-component childhood obesity prevention community-randomized controlled trial: patterns, determinants, and implications. Trials. 2018 May 22;19(1):287. doi: 10.1186/s13063-018-2663-y.

Related Links

MeSH Terms

Conditions

Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Joel Gittelsohn, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2014

First Posted

July 3, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

October 7, 2022

Record last verified: 2022-10

Locations