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

June 13, 2011
March 4, 2014
June 2011
August 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01374815 on ClinicalTrials.gov Archive Site
Physical activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Physical activity will be assessed using the NHANES survey.
Same as current
Not Provided
Not Provided
 
The Online Advocate: Health Related Social Problems And Diet Quality Pilot Study
The Online Advocate: Health Related Social Problems And Diet Quality Pilot Study

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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
  • Children's Diet Quality
  • Health-related Social Problems
  • 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
Experimental: The Online Advocate
Interventions:
  • Other: The Online Advocate
  • Other: The Online Advocate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01374815
X10-07-335
No
Clement Bottino, Children's Hospital Boston
Children's Hospital Boston
Not Provided
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
Children's Hospital Boston
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP