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

• ClinicalTrials.gov Identifier: NCT02138240
• Recruitment Status: Completed
• First Posted: May 14, 2014
• Results First Posted: July 9, 2019
• Last Update Posted: July 9, 2019
• Sponsor: Johns Hopkins University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Johns Hopkins University

Tracking Information

• First Submitted Date: May 9, 2014
• First Posted Date: May 14, 2014
• Results First Submitted Date: June 17, 2019
• Results First Posted Date: July 9, 2019
• Last Update Posted Date: July 9, 2019
• Actual Study Start Date: January 15, 2017
• Actual Primary Completion Date: November 20, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 17, 2019)

• Number of Sessions Attended [ Time Frame: 3 months ]
  Number of sessions attended calculated from attendance sign-in sheets. This is used for the assessment of program feasibility.
• Participant Satisfaction as Assessed by 4-point Likert Scale [ Time Frame: 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.
• Participant's Likelihood to Recommend Program Assessed by 4-point Likert Scale [ Time Frame: 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.
• Added Sugar Intake (Teaspoons/Day) Among Total Sample at Follow up [ Time Frame: 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.

Original Primary Outcome Measures (submitted: May 12, 2014)

• Change in healthy eating index score among alters [ Time Frame: Baseline; 6 months ]
• Change in eating behavior inventory score in alters [ Time Frame: Baseline; 6 months ]
• Change in Baecke exercise scores among alters [ Time Frame: Baseline; 6 months ]
• Satisfaction with intervention [ Time Frame: 12 weeks ]
  Satisfaction with intervention will be assessed among participants or egos using a 4-point Likert scale.
• Attendance [ Time Frame: 12 weeks ]
  We will calculate the average number of group intervention sessions attended.

Current Secondary Outcome Measures (submitted: June 17, 2019)

• Added Sugar Intake (Teaspoons/Day) Among Alters ("Sidekicks") at Follow up [ Time Frame: 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.
• Added Sugar Intake (Teaspoons/Day) Among Egos ("Peer Educators") at Follow up [ Time Frame: 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.
• Median Weight at Follow up [ Time Frame: 6 months ]
  Weight (kg) measured using standard methods

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sugar Champ: Pilot Social Network Intervention to Reduce Intake of Sugary Drinks
• Official Title: Sugar Champ: Pilot Social Network Intervention to Reduce Intake of Sugary Drinks
• 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Overweight and Obesity

Intervention

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.

Study Arms

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.

Intervention: Behavioral: Social network intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 4, 2017): 34
• Original Enrollment: Not Provided
• Actual Study Completion Date: November 20, 2017
• Actual Primary Completion Date: November 20, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02138240
• Other Study ID Numbers: IRB00107116; K23HL116601 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Johns Hopkins University
• Study Sponsor: Johns Hopkins University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

• PRS Account: Johns Hopkins University
• Verification Date: June 2019