The Online Advocate: Health Related Social Problems And Diet Quality Pilot Study

March 4, 2014 updated by: Clement Bottino, Boston Children's Hospital

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. 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. 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.

Our Study Hypotheses are:

  1. A greater number of health-related social problems per family will be associated with poorer diet quality in children at baseline.
  2. 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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 01225
        • Children's Hospital, Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Online Advocate
The Online Advocate is a Web-based social problems screening and referral tool developed at Children's Hospital.
The Online Advocate is a Web-based screening and referral tool for health-related social problems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diet quality
Time Frame: 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: 3 months
Physical activity will be assessed using the NHANES survey.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joanne E Cox, MD, Boston Children's Hospital
  • Study Director: Clement J Bottino, MD, Boston Children's Hospital
  • Principal Investigator: Erinn T Rhodes, MD, MPH, Boston Children's Hospital
  • Principal Investigator: Eric W Fleegler, MD, MPH, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

June 13, 2011

First Submitted That Met QC Criteria

June 15, 2011

First Posted (Estimate)

June 16, 2011

Study Record Updates

Last Update Posted (Estimate)

March 5, 2014

Last Update Submitted That Met QC Criteria

March 4, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • X10-07-335

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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