- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02138240
Sugar Champ: Pilot Social Network Intervention to Reduce Intake of Sugary Drinks
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
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.
|
6 months
|
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.
|
6 months
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
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.
|
6 months
|
Median Weight at Follow up
Time Frame: 6 months
|
Weight (kg) measured using standard methods
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kimberly Gudzune, MD, MPH, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00107116
- K23HL116601 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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