Healthy Eating and Active Living Taught at Home (HEALTH)
The purpose of this research study is to evaluate two different Parents as Teachers curriculums taught by parent educators, during home visits. The control curriculum includes only the standard PAT lessons; the intervention curriculum includes the standard PAT lessons plus additional information about how families can live healthy and active lives while reaching a healthy weight. The investigators hypothesize the intervention lessons will change the way people eat and/or their activity level.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Translating a Weight Loss Intervention Through a National Home Visiting Program|
- Body Mass Index [ Time Frame: Change in BMI from baseline to 24 months ] [ Designated as safety issue: No ]Body mass index (BMI) will be used to classify participants as "obese". The investigators will calculate the BMI from weight and height measurements. Participants weight measurement will be obtained using a calibrated scale placed on a solid flat surface. The screener will record the weight in pounds. Height measurement will be the maximum vertical height measured using a stadiometer on a solid flat surface with a fixed vertical backboard and an adjustable headpiece or an approved portable stadiometer on a solid flat surface with an adjustable headpiece.
- Waist Circumference [ Time Frame: Change in waist circumference from baseline to 24 months ] [ Designated as safety issue: No ]Waist circumference will be used to estimate abdominal adiposity which is associated with risk of Type 2 diabetes.
- Blood Pressure [ Time Frame: Change in blood pressure from baseline to 24 months ] [ Designated as safety issue: No ]In accordance with American Heart Association guidelines, we will follow the recommendations and protocol for blood pressure measurement.
- Survey [ Time Frame: Changes in surveys from baseline to 24 months ] [ Designated as safety issue: No ]Survey includes: dietary screener, International Physical Activity Questionnaire, SF-12 to assess quality of life, a knowledge test to reflect the HEALTH intervention, questions asking about lifestyle patterns, environmental questions, sleep, Preschooler Feeding Questionnaire
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Behavioral: PAT Curriculum + Health Information
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567033
|Contact: Debra Haire-Joshu, PhDfirstname.lastname@example.org|
|Contact: Christina Lapka, MSemail@example.com|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63112|
|Contact: Debra Haire Joshu, PhD 314-935-3963 firstname.lastname@example.org|
|Principal Investigator: Debra Haire Joshu, PhD|
|Principal Investigator:||Debra Haire Joshu, PhD||Washington University School of Medicine|