Overweight and ObesityNCT02138240
Sugar Champ: Pilot Social Network Intervention to Reduce Intake of Sugary Drinks
A study testing Social network intervention in people with Overweight and Obesity, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Social network intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2017to 20 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Social network intervention
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social network interventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Social network intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Sessions Attended
Number of sessions attended calculated from attendance sign-in sheets. This is used for the assessment of program feasibility.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 6 months
Median Weight at Follow up
Weight (kg) measured using standard methods
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study start15 Jan 2017
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Kimberly Gudzune, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138240
- Sponsor's protocol ID
- IRB00107116
- Other IDs
- K23HL116601
- Status last verified
- Jun 2019
- First submitted
- 9 May 2014
- Last updated
- 9 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugar Champ: Pilot Social Network Intervention to Reduce Intake of Sugary Drinks
- ClinicalTrials.gov ID
- NCT02138240
- Acronym / sponsor ID
- IRB00107116
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Posted 9 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social network intervention | Experimental | Behavioral: Social network interventionIndividuals 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social network interventionThe 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. | Behavioural | Social network intervention |
Primary outcome
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.
3 secondary outcomes
Added Sugar Intake (Teaspoons/Day) Among Alters ("Sidekicks") at Follow up
Time frame: 6 months
Added Sugar Intake (Teaspoons/Day) Among Egos ("Peer Educators") at Follow up
Time frame: 6 months
Median Weight at Follow up
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Gudzune, MD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social network intervention in people with Overweight and Obesity, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Sessions Attended (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.