ObesityBHCKNCT02181010
B'More Healthy; Communities for Kids (BHCK)
A study testing Intervention in people with Obesity, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 890 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Intervention
- Keywords
- 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
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 years
Secondary outcomes (1)
Household Healthy Food Purchasing
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).
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 890 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel Gittelsohn, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181010
- Sponsor's protocol ID
- 111189
- Acronym
- BHCK
- Status last verified
- Oct 2022
- First submitted
- 20 Jun 2014
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25729465Gittelsohn 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.
PubMed 25209072Anderson 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.
PubMed 25574452Gudzune 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.
PubMed 25649045Gittelsohn 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.
PubMed 26069864Sattler 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.
PubMed 25706350Vedovato 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.
PubMed 26441159Anderson 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.
PubMed 26865358Gittelsohn 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.
PubMed 26598834Mui 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.
PubMed 26633434Wong 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.
PubMed 26700158Sato 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.
PubMed 26936480Ewart-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.
PubMed 27379620Trude 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.
PubMed 30373597Trude 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.
PubMed 29788977
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B'More Healthy: Communities for Kids (BHCK)
- ClinicalTrials.gov ID
- NCT02181010
- Acronym / sponsor ID
- BHCK / 111189
- Conditions
- Obesity
- Keywords
- African American, Adolescents, Urban, Food Desert, Food Insecurity, Obesity, Baltimore City, Peer mentors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 890 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionThe 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. |
| 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. |
Who may qualify
- Ages
- 9 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionIntervention 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). | Behavioural | Intervention |
Primary outcome
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.
1 secondary outcome
Household Healthy Food Purchasing
Time frame: Up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Background: PubMed 25729465Coakley 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.
- Background: PubMed 25209072Gittelsohn 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.
- Background: PubMed 25574452Anderson 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.
- Background: PubMed 25649045Gudzune 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.
- Background: PubMed 26069864Gittelsohn 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.
- Background: PubMed 25706350Sattler 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.
- Background: PubMed 26441159Vedovato 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.
- Background: PubMed 26865358Anderson 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.
- Background: PubMed 26598834Gittelsohn 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.
- Background: PubMed 26633434Mui 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.
- Background: PubMed 26700158Wong 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.
- Background: PubMed 26936480Sato 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.
- Healthy Stores WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Gittelsohn, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Obesity, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Small Retail Food Store - Healthy Food Availability (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02181010, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.