Sugar Champ: Pilot Social Network Intervention to Reduce Intake of Sugary Drinks

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02138240
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 34
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.2
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Behavioral: Social network intervention	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sugar Champ: Pilot Social Network Intervention to Reduce Intake of Sugary Drinks
• Actual Study Start Date: Jan 15, 2017
• Actual Primary Completion Date: Nov 20, 2017
• Actual Study Completion Date: Nov 20, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Number of Sessions Attended [3 months]

   Number of sessions attended calculated from attendance sign-in sheets. This is used for the assessment of program feasibility.

2. Participant Satisfaction as Assessed by 4-point Likert Scale [6 months]

   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.

3. Participant's Likelihood to Recommend Program Assessed by 4-point Likert Scale [6 months]

   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.

4. Added Sugar Intake (Teaspoons/Day) Among Total Sample at Follow up [6 months]

   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.

Secondary Outcome Measures

1. Added Sugar Intake (Teaspoons/Day) Among Alters ("Sidekicks") at Follow up [6 months]

   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.

2. Added Sugar Intake (Teaspoons/Day) Among Egos ("Peer Educators") at Follow up [6 months]

   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.

3. Median Weight at Follow up [6 months]

   Weight (kg) measured using standard methods

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• At least 18 years old

• BMI≥25 kg/m2

• Must consume sugar-sweetened beverages at least twice daily

• "Peer Educators" must identify one high-risk alter in the social network to enroll as "Sidekick"

• Resides in select public housing developments in Baltimore, MD

Exclusion Criteria:

• Any underlying medical conditions that could seriously reduce life expectancy, ability to participate in the trial, or for which lifestyle change may be contraindicated and/or require medical supervision by a physician such as medication-dependent diabetes mellitus, cancer, lung disease requiring supplemental oxygen, dementia, angina, or diagnosis in the last 12 months of myocardial infarction, transient ischemic attack or stroke

• Women who are pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University School of Medicine	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Kimberly Gudzune, MD, MPH, Johns Hopkins University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 23, 2017

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02138240
• Other Study ID Numbers: IRB00107116; K23HL116601
• First Posted: May 14, 2014
• Last Update Posted: Jul 9, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Overweight

Study Results

Participant Flow

Arm/Group Title	Social Network Intervention
Arm/Group Description	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.
Period Title: Overall Study
STARTED	34
COMPLETED	34
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Social Network Intervention
Arm/Group Description	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.
Overall Participants	34
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.7 (12.0)
Sex: Female, Male (Count of Participants)
Female	27 79.4%
Male	7 20.6%
Race/Ethnicity, Customized (Count of Participants)
African-American	33 97.1%
Other	1 2.9%
Added sugar intake total sample (teaspoons/day) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [teaspoons/day]	38.0
Added Sugar Intake among Sidekicks (teaspoons/day) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [teaspoons/day]	37.0
Added Sugar Intake among Peer Educators (teaspoons/day) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [teaspoons/day]	42.4
Weight, continuous (kg) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg]	85.9
Body mass index, continuous (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	32.1 (6.7)

Outcome Measures

1. Primary Outcome

Title	Number of Sessions Attended
Description	Number of sessions attended calculated from attendance sign-in sheets. This is used for the assessment of program feasibility.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Limited to Peer Educators who had the opportunity to attend the sessions.

Arm/Group Title	Social Network Intervention
Arm/Group Description	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.
Measure Participants	17
Median (Inter-Quartile Range) [Number of sessions]	9

2. Primary Outcome

Title	Participant Satisfaction as Assessed by 4-point Likert Scale
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Social Network Intervention
Arm/Group Description	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.
Measure Participants	34
Very satisfied	30 88.2%
Somewhat satisfied	4 11.8%
Somewhat dissatisfied	0 0%
Very dissatisfied	0 0%

3. Primary Outcome

Title	Participant's Likelihood to Recommend Program Assessed by 4-point Likert Scale
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Social Network Intervention
Arm/Group Description	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.
Measure Participants	34
Very likely	31 91.2%
Somewhat likely	3 8.8%
Somewhat unlikely	0 0%
Very unlikely	0 0%

4. Primary Outcome

Title	Added Sugar Intake (Teaspoons/Day) Among Total Sample at Follow up
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Social Network Intervention
Arm/Group Description	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.
Measure Participants	34
Median (Inter-Quartile Range) [teaspoons/day]	17.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Social Network Intervention
	Comments
	Type of Statistical Test	Other
	Comments	Pre-post comparison
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon signed rank sum
	Comments

5. Secondary Outcome

Title	Added Sugar Intake (Teaspoons/Day) Among Alters ("Sidekicks") at Follow up
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Limited to Sidekicks only

Arm/Group Title	Social Network Intervention
Arm/Group Description	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.
Measure Participants	17
Median (Inter-Quartile Range) [teaspoons/day]	16.9

6. Secondary Outcome

Title	Added Sugar Intake (Teaspoons/Day) Among Egos ("Peer Educators") at Follow up
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Limited to Peer Educators

Arm/Group Title	Social Network Intervention
Arm/Group Description	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.
Measure Participants	17
Median (Inter-Quartile Range) [teaspoons/day]	17.4

7. Secondary Outcome

Title	Median Weight at Follow up
Description	Weight (kg) measured using standard methods
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Social Network Intervention
Arm/Group Description	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.
Measure Participants	34
Median (Inter-Quartile Range) [kg]	84.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Social Network Intervention
	Comments
	Type of Statistical Test	Other
	Comments	Pre-post comparison of baseline median weight to median weight at 6-month follow up
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	Wilcoxon signed rank sum
	Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	Social Network Intervention
Arm/Group Description	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.
All Cause Mortality
	Social Network Intervention
	Affected / at Risk (%)	# Events
Total	0/34 (0%)
Serious Adverse Events
	Social Network Intervention
	Affected / at Risk (%)	# Events
Total	0/34 (0%)
Other (Not Including Serious) Adverse Events
	Social Network Intervention
	Affected / at Risk (%)	# Events
Total	0/34 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.