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

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	Not Applicable

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 (Clinical Trial)
• 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: January 15, 2017
• Actual Primary Completion Date: November 20, 2017
• Actual Study Completion Date: November 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 [ Time Frame: 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 [ 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.
3. 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.
4. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. Median Weight at Follow up [ Time Frame: 6 months ]
   Weight (kg) measured using standard methods

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Maryland

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)

Documents provided by Johns Hopkins University:

Study Protocol and Statistical Analysis Plan  [PDF] January 23, 2017

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02138240
• Other Study ID Numbers: IRB00107116; K23HL116601 ( U.S. NIH Grant/Contract )
• First Posted: May 14, 2014
• Results First Posted: July 9, 2019
• Last Update Posted: July 9, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• 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; Body Weight