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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL116601 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The 1.2 million households living in public housing are disproportionately affected by obesity, where prevalence is estimated at 50%. An ecologic framework hypothesizes that this disparity is related, in part, to social and environmental factors within these neighborhoods that influence residents' lifestyles. Social networks and the built environment may work together to promote or inhibit lifestyle behaviors; however, combined social network-built environment interventions have not previously targeted changes in diet. Investigators hypothesize that an intervention that combines a social network approach with strategies that address public housing residents' challenges related to the built environment will improve dietary habits. The investigators' overall aim is to develop a combined social network-built environment intervention to reduce intake of beverages high in added sugars and to pilot test the intervention among residents of public housing developments in Baltimore, MD. The investigators' aim for this work is: 1) To develop a combined social network-built environment intervention to reduce intake of beverages high in added sugars and to pilot test the intervention among residents of public housing developments in Baltimore, MD. Investigators hypothesize that a social network intervention will be feasible and acceptable in promoting healthy lifestyle change, and that this intervention will alter lifestyle behaviors among public housing residents.
Investigators will conduct a 6-month non-randomized trial of the social network intervention described below. This will be a single arm trial in which investigators compare the outcomes of interest pre- and post- intervention. Investigators will adapt an HIV risk reduction social network intervention to create a new social network intervention targeting reduction in intake of sugar-sweetened beverages (SSB). The investigators' primary outcomes will be to test the acceptability and feasibility of the intervention and its components as well as estimate the likely effect of the intervention.
In the intervention, individuals will be recruited and trained to be "Peer Educators" who will participate in group sessions and then communicate this information with members of participant's social network ("Sidekick") and work to make changes to reduce intake of added sugars together. Given the frequent intake of SSB in this population, the intervention will focus on reducing added sugar intake through the reduced consumption of SSB. Peer Educators will participate in 6 core group sessions over a 6-week period as well as 3 additional booster sessions after completing the core curriculum. All sessions will be delivered by a facilitator and assistant facilitator using a guide. All groups will be held in a room in each public housing development's administrative building.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social network intervention | Experimental | Individuals will be recruited and trained to be "Peer Educators" who will participate in group sessions and then communicate this information with members of participant's social network ("Sidekick") and work to make changes to reduce intake of sugar-sweetened beverages. Peer Educators will participate in 6 core group sessions over a 6-week period as well as 3 additional booster sessions over the subsequent 3 months after completing the core curriculum. All sessions will be delivered by a facilitator and assistant facilitator using a guide. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social network intervention | Behavioral | The intervention combined a social network approach with strategies that address public housing residents' challenges related to the built environment to improve dietary habits. Given the frequent intake of sugar-sweetened beverages (SSB) in this population, the intervention focused on reducing added sugar intake through the reduced consumption of SSB. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sessions Attended | Number of sessions attended calculated from attendance sign-in sheets. This is used for the assessment of program feasibility. | 3 months |
| Participant Satisfaction as Assessed by 4-point Likert Scale | Survey question assesses participant satisfaction with the intervention using a 4-point Likert scale (1 = Very satisfied; 2= Somewhat satisfied; 3 = Somewhat dissatisfied; 4 = Very dissatisfied). This is used for the assessment of program acceptability. | 6 months |
| Participant's Likelihood to Recommend Program Assessed by 4-point Likert Scale | Survey question assesses willingness to recommend that a friend participate using a 4-point Likert scale (1 = Very likely; 2= Somewhat likely; 3 = Somewhat unlikely; 4 = Very unlikely). This is used to assess the program acceptability. | 6 months |
| Added Sugar Intake (Teaspoons/Day) Among Total Sample at Follow up | Participants answered questions from the National Health Interview Survey (NHIS) 5-factor dietary screener, and relevant elements as recommended by NHIS were combined to estimate the daily added sugar intake (i.e.,soda, sugar-sweetened beverages, sweets and doughnuts). At 6 months, this measure ranged (min-max) from 9.1 to 56.0 teaspoons/day in this sample. The American Heart Association recommends that all adults limit their added sugar intake to no more than 9 teaspoons per day. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Added Sugar Intake (Teaspoons/Day) Among Alters ("Sidekicks") at Follow up | Participants answered questions from the National Health Interview Survey (NHIS) 5-factor dietary screener, and relevant elements as recommended by NHIS were combined to estimate the daily added sugar intake (i.e.,soda, sugar-sweetened beverages, sweets and doughnuts). The American Heart Association recommends that all adults limit their added sugar intake to no more than 9 teaspoons per day. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Gudzune, MD, MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Social Network Intervention | Individuals will be recruited and trained to be "Peer Educators" who will participate in group sessions and then communicate this information with members of their social network ("Sidekick") and work to make changes to reduce intake of sugar-sweetened beverages. Peer Educators will participate in 6 core group sessions over a 6-week period as well as 3 additional booster sessions over the subsequent 3 months after completing the core curriculum. All sessions will be delivered by a facilitator and assistant facilitator using a guide. Social network intervention: The intervention combined a social network approach with strategies that address public housing residents' challenges related to the built environment to improve dietary habits. Given the frequent intake of sugar-sweetened beverages (SSB) in this population, the intervention focused on reducing added sugar intake through the reduced consumption of SSB. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Social Network Intervention | Individuals will be recruited and trained to be "Peer Educators" who will participate in group sessions and then communicate this information with members of their social network ("Sidekick") and work to make changes to reduce intake of sugar-sweetened beverages. Peer Educators will participate in 6 core group sessions over a 6-week period as well as 3 additional booster sessions over the subsequent 3 months after completing the core curriculum. All sessions will be delivered by a facilitator and assistant facilitator using a guide. Social network intervention: The intervention combined a social network approach with strategies that address public housing residents' challenges related to the built environment to improve dietary habits. Given the frequent intake of sugar-sweetened beverages (SSB) in this population, the intervention focused on reducing added sugar intake through the reduced consumption of SSB. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Sessions Attended | Number of sessions attended calculated from attendance sign-in sheets. This is used for the assessment of program feasibility. | Limited to Peer Educators who had the opportunity to attend the sessions. | Posted | Median | Inter-Quartile Range | Number of sessions | 3 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Social Network Intervention | Individuals will be recruited and trained to be "Peer Educators" who will participate in group sessions and then communicate this information with members of their social network ("Sidekick") and work to make changes to reduce intake of sugar-sweetened beverages. Peer Educators will participate in 6 core group sessions over a 6-week period as well as 3 additional booster sessions over the subsequent 3 months after completing the core curriculum. All sessions will be delivered by a facilitator and assistant facilitator using a guide. Social network intervention: The intervention combined a social network approach with strategies that address public housing residents' challenges related to the built environment to improve dietary habits. Given the frequent intake of sugar-sweetened beverages (SSB) in this population, the intervention focused on reducing added sugar intake through the reduced consumption of SSB. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Gudzune | Johns Hopkins University School of Medicine | 443-287-7238 | gudzune@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2017 | Jun 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 6 months |
| Added Sugar Intake (Teaspoons/Day) Among Egos ("Peer Educators") at Follow up | Participants answered questions from the National Health Interview Survey (NHIS) 5-factor dietary screener, and relevant elements as recommended by NHIS were combined to estimate the daily added sugar intake (i.e.,soda, sugar-sweetened beverages, sweets and doughnuts). The American Heart Association recommends that all adults limit their added sugar intake to no more than 9 teaspoons per day. | 6 months |
| Median Weight at Follow up | Weight (kg) measured using standard methods | 6 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Added sugar intake total sample | Participants answered questions from the National Health Interview Survey (NHIS) 5-factor dietary screener. Relevant elements as recommended by NHIS were combined to estimate the daily added sugar intake (i.e.,soda, sugar-sweetened beverages, sweets and doughnuts). Prior assessments of African-Americans report that typical added sugar intake is 13.9 and 19.4 teaspoons/day among women and men, respectively. The American Heart Association recommends that all adults limit their added sugar intake to no more than 9 teaspoons per day. Baseline range (min-max) in this sample 14.1-78.9 teaspoons/day. | Median | Inter-Quartile Range | teaspoons/day |
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| Added Sugar Intake among Sidekicks | Participants answered questions from the National Health Interview Survey (NHIS) 5-factor dietary screener, and relevant elements as recommended by NHIS were combined to estimate the daily added sugar intake (i.e.,soda, sugar-sweetened beverages, sweets and doughnuts). | Limited to only Sidekicks | Median | Inter-Quartile Range | teaspoons/day |
|
| Added Sugar Intake among Peer Educators | Participants answered questions from the National Health Interview Survey (NHIS) 5-factor dietary screener, and relevant elements as recommended by NHIS were combined to estimate the daily added sugar intake (i.e.,soda, sugar-sweetened beverages, sweets and doughnuts). | Limited to only Peer Educators | Median | Inter-Quartile Range | teaspoons/day |
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| Weight, continuous | Median | Inter-Quartile Range | kg |
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| Body mass index, continuous | Mean | Standard Deviation | kg/m^2 |
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| Primary | Participant Satisfaction as Assessed by 4-point Likert Scale | Survey question assesses participant satisfaction with the intervention using a 4-point Likert scale (1 = Very satisfied; 2= Somewhat satisfied; 3 = Somewhat dissatisfied; 4 = Very dissatisfied). This is used for the assessment of program acceptability. | Posted | Count of Participants | Participants | 6 months |
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| Primary | Participant's Likelihood to Recommend Program Assessed by 4-point Likert Scale | Survey question assesses willingness to recommend that a friend participate using a 4-point Likert scale (1 = Very likely; 2= Somewhat likely; 3 = Somewhat unlikely; 4 = Very unlikely). This is used to assess the program acceptability. | Posted | Count of Participants | Participants | 6 months |
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| Primary | Added Sugar Intake (Teaspoons/Day) Among Total Sample at Follow up | Participants answered questions from the National Health Interview Survey (NHIS) 5-factor dietary screener, and relevant elements as recommended by NHIS were combined to estimate the daily added sugar intake (i.e.,soda, sugar-sweetened beverages, sweets and doughnuts). At 6 months, this measure ranged (min-max) from 9.1 to 56.0 teaspoons/day in this sample. The American Heart Association recommends that all adults limit their added sugar intake to no more than 9 teaspoons per day. | Posted | Median | Inter-Quartile Range | teaspoons/day | 6 months |
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| Secondary | Added Sugar Intake (Teaspoons/Day) Among Alters ("Sidekicks") at Follow up | Participants answered questions from the National Health Interview Survey (NHIS) 5-factor dietary screener, and relevant elements as recommended by NHIS were combined to estimate the daily added sugar intake (i.e.,soda, sugar-sweetened beverages, sweets and doughnuts). The American Heart Association recommends that all adults limit their added sugar intake to no more than 9 teaspoons per day. | Limited to Sidekicks only | Posted | Median | Inter-Quartile Range | teaspoons/day | 6 months |
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| Secondary | Added Sugar Intake (Teaspoons/Day) Among Egos ("Peer Educators") at Follow up | Participants answered questions from the National Health Interview Survey (NHIS) 5-factor dietary screener, and relevant elements as recommended by NHIS were combined to estimate the daily added sugar intake (i.e.,soda, sugar-sweetened beverages, sweets and doughnuts). The American Heart Association recommends that all adults limit their added sugar intake to no more than 9 teaspoons per day. | Limited to Peer Educators | Posted | Median | Inter-Quartile Range | teaspoons/day | 6 months |
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| Secondary | Median Weight at Follow up | Weight (kg) measured using standard methods | Posted | Median | Inter-Quartile Range | kg | 6 months |
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| 0 |
| 34 |
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| 34 |
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| 34 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Very dissatisfied |
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| Title | Measurements |
|---|---|
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| Very unlikely |
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