NCT01374815

Brief Summary

In this study, the investigators will be using The Online Advocate, a Web-based health-related social problems screening and referral tool, to explore the relationship between health-related social problems and children's diet quality among families with young children attending the Children's Hospital Primary Care Center. The Online Advocate consists of a 60-80 question screening survey for health-related social problems (such as food insecurity, employment and income, homelessness) and allows participants to select referrals for local health and social service agencies that might help them with the problems identified through the survey. Layered into The Online Advocate for this study is an adaptation of the Harvard Service Food Frequency Questionnaire (HSFFQ) that can assess children's diet quality. The investigators plan to recruit 350 parent/guardians of otherwise healthy children age 3-10 years who are presenting to the primary care center for routine well child care. Eligible parent/guardians will have the opportunity to take The Online Advocate (plus HSFFQ) on a laptop computer in the waiting area before seeing their pediatrician or healthcare provider. Participants will receive a small incentive for their time as well as written information on healthy nutrition and an age appropriate coloring book for the child. At one month, participants will be contacted by the study team by email or phone and asked follow up questions about the status of their health-related social problems identified through The Online Advocate and whether the referrals they received were helpful. Participants will receive a small incentive for their time, along with a reminder message promoting healthy nutrition for their child. At three months, participants will be contacted by the study team by email or phone and asked follow up questions about the status of their health-related social problems identified through The Online Advocate and whether the referrals they received were helpful. They will also re-take the adapted HSFFQ. Participants will receive another small incentive for their time. Participants will also have the opportunity to re-take The Online Advocate at three months, though this is optional. The investigators believe this pilot study will provide foundational knowledge about the intersection between health-related social problems and children's diet quality and may inform future research studies and interventions. Our Study Aims are:

  1. 1.To use The Online Advocate to evaluate the association between health-related social problems and diet quality in children in a cross-sectional sample.
  2. 2.To evaluate the relationship between resolution of health-related social problems using The Online Advocate and change in diet quality in children over a 3 month period.
  3. 3.A greater number of health-related social problems per family will be associated with poorer diet quality in children at baseline.
  4. 4.After 3 months, families demonstrating resolution of one or more health-related social problems addressed with The Online Advocate will demonstrate greater improvement in diet quality in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

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

Study Start

First participant enrolled

June 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

1.2 years

First QC Date

June 13, 2011

Last Update Submit

March 4, 2014

Conditions

Keywords

Children's diet qualityHealth-related social problems

Outcome Measures

Primary Outcomes (1)

  • Diet quality

    Diet quality will be assessed using the HEI-2005, Healthy Eating Index, applied to the nutritional data collected using the HSFFQ survey. HEI-2005 provides an overall score (scale 0 to 100) and was developed by the USDA Center for Nutrition Policy and Promotion to assess compliance with dietary guidelines.

    3 months

Secondary Outcomes (1)

  • Physical activity

    3 months

Study Arms (1)

The Online Advocate

EXPERIMENTAL
Other: The Online Advocate

Interventions

The Online Advocate is a Web-based social problems screening and referral tool developed at Children's Hospital.

The Online Advocate

Eligibility Criteria

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

You may qualify if:

  • Child age 3 to 10 years
  • Child lives with parent/guardian at least 5 days per week
  • Parent/guardian must be able to speak and read in English

You may not qualify if:

  • Child with major, active chronic medical illness (e.g., cancer) or use of prescription medication (e.g., oral steroids) that might influence diet quality
  • Prior use of The Online Advocate
  • Prior study participation
  • Child is first degree relative (e.g., sibling) of current or prior study participant or a family member with lesser degree of relatedness or non-relative who lives in the same household as a current or prior study participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital, Boston

Boston, Massachusetts, 01225, United States

Location

Related Publications (1)

  • Bottino CJ, Fleegler EW, Cox JE, Rhodes ET. The Relationship Between Housing Instability and Poor Diet Quality Among Urban Families. Acad Pediatr. 2019 Nov-Dec;19(8):891-898. doi: 10.1016/j.acap.2019.04.004. Epub 2019 Apr 13.

Study Officials

  • Joanne E Cox, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR
  • Clement J Bottino, MD

    Boston Children's Hospital

    STUDY DIRECTOR
  • Erinn T Rhodes, MD, MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR
  • Eric W Fleegler, MD, MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, study coordinator

Study Record Dates

First Submitted

June 13, 2011

First Posted

June 16, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations