NCT02138240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
2.7 years until next milestone

Study Start

First participant enrolled

January 15, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 9, 2019

Completed
Last Updated

July 9, 2019

Status Verified

June 1, 2019

Enrollment Period

10 months

First QC Date

May 9, 2014

Results QC Date

June 17, 2019

Last Update Submit

June 17, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Number of Sessions Attended

    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

    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

    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

    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 Outcomes (3)

  • Added Sugar Intake (Teaspoons/Day) Among Alters ("Sidekicks") at Follow up

    6 months

  • Added Sugar Intake (Teaspoons/Day) Among Egos ("Peer Educators") at Follow up

    6 months

  • Median Weight at Follow up

    6 months

Study Arms (1)

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.

Behavioral: Social network intervention

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.

Social network intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Kimberly Gudzune
Organization
Johns Hopkins University School of Medicine

Study Officials

  • Kimberly Gudzune, MD, MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2014

First Posted

May 14, 2014

Study Start

January 15, 2017

Primary Completion

November 20, 2017

Study Completion

November 20, 2017

Last Updated

July 9, 2019

Results First Posted

July 9, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations