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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02138240
Enrollment
34
Registered
2014-05-14
Start date
2017-01-15
Completion date
2017-11-20
Last updated
2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

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.

Interventions

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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Number of Sessions Attended3 monthsNumber 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 Scale6 monthsSurvey 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 Scale6 monthsSurvey 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 up6 monthsParticipants 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

MeasureTime frameDescription
Added Sugar Intake (Teaspoons/Day) Among Egos (Peer Educators) at Follow up6 monthsParticipants 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 up6 monthsWeight (kg) measured using standard methods
Added Sugar Intake (Teaspoons/Day) Among Alters (Sidekicks) at Follow up6 monthsParticipants 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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 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.
34
Total34

Baseline characteristics

CharacteristicSocial Network Intervention
Added Sugar Intake among Peer Educators42.4 teaspoons/day
Added Sugar Intake among Sidekicks37.0 teaspoons/day
Added sugar intake total sample38.0 teaspoons/day
Age, Continuous45.7 years
STANDARD_DEVIATION 12
Body mass index, continuous32.1 kg/m^2
STANDARD_DEVIATION 6.7
Race/Ethnicity, Customized
African-American
33 Participants
Race/Ethnicity, Customized
Other
1 Participants
Sex: Female, Male
Female
27 Participants
Sex: Female, Male
Male
7 Participants
Weight, continuous85.9 kg

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 34
other
Total, other adverse events
0 / 34
serious
Total, serious adverse events
0 / 34

Outcome results

Primary

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.

Time frame: 6 months

ArmMeasureValue (MEDIAN)
Social Network InterventionAdded Sugar Intake (Teaspoons/Day) Among Total Sample at Follow up17.2 teaspoons/day
p-value: <0.001Wilcoxon signed rank sum
Primary

Number of Sessions Attended

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

Time frame: 3 months

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

ArmMeasureValue (MEDIAN)
Social Network InterventionNumber of Sessions Attended9 Number of sessions
Primary

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.

Time frame: 6 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Social Network InterventionParticipant Satisfaction as Assessed by 4-point Likert ScaleVery satisfied30 Participants
Social Network InterventionParticipant Satisfaction as Assessed by 4-point Likert ScaleSomewhat satisfied4 Participants
Social Network InterventionParticipant Satisfaction as Assessed by 4-point Likert ScaleSomewhat dissatisfied0 Participants
Social Network InterventionParticipant Satisfaction as Assessed by 4-point Likert ScaleVery dissatisfied0 Participants
Primary

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.

Time frame: 6 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Social Network InterventionParticipant's Likelihood to Recommend Program Assessed by 4-point Likert ScaleVery likely31 Participants
Social Network InterventionParticipant's Likelihood to Recommend Program Assessed by 4-point Likert ScaleSomewhat likely3 Participants
Social Network InterventionParticipant's Likelihood to Recommend Program Assessed by 4-point Likert ScaleSomewhat unlikely0 Participants
Social Network InterventionParticipant's Likelihood to Recommend Program Assessed by 4-point Likert ScaleVery unlikely0 Participants
Secondary

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.

Time frame: 6 months

Population: Limited to Sidekicks only

ArmMeasureValue (MEDIAN)
Social Network InterventionAdded Sugar Intake (Teaspoons/Day) Among Alters (Sidekicks) at Follow up16.9 teaspoons/day
Secondary

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.

Time frame: 6 months

Population: Limited to Peer Educators

ArmMeasureValue (MEDIAN)
Social Network InterventionAdded Sugar Intake (Teaspoons/Day) Among Egos (Peer Educators) at Follow up17.4 teaspoons/day
Secondary

Median Weight at Follow up

Weight (kg) measured using standard methods

Time frame: 6 months

ArmMeasureValue (MEDIAN)
Social Network InterventionMedian Weight at Follow up84.3 kg
p-value: 0.21Wilcoxon signed rank sum

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026