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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clement Bottino, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01374815
First received: June 13, 2011
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.

Condition Intervention
Children's Diet Quality
Health-related Social Problems
Other: The Online Advocate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: The Online Advocate: Health Related Social Problems And Diet Quality Pilot Study

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Diet quality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Physical activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Physical activity will be assessed using the NHANES survey.


Enrollment: 350
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: The Online Advocate Other: The Online Advocate
The Online Advocate is a Web-based social problems screening and referral tool developed at Children's Hospital.
Other: The Online Advocate
The Online Advocate is a Web-based screening and referral tool for health-related social problems

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374815

Locations
United States, Massachusetts
Children's Hospital, Boston
Boston, Massachusetts, United States, 01225
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Joanne E Cox, MD Children's Hospital Boston
Study Director: Clement J Bottino, MD Children's Hospital Boston
Principal Investigator: Erinn T Rhodes, MD, MPH Children's Hospital Boston
Principal Investigator: Eric W Fleegler, MD, MPH Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Clement Bottino, Principal investigator, study coordinator, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01374815     History of Changes
Other Study ID Numbers: X10-07-335
Study First Received: June 13, 2011
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Children's diet quality
Health-related social problems

ClinicalTrials.gov processed this record on August 26, 2014