Healthy Eating and Active Living Taught at Home (HEALTH)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01567033
First received: March 14, 2012
Last updated: June 2, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Diabetes
Obesity
Behavioral: PAT Curriculum + Health Information

Study Type: Interventional
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

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 512
Study Start Date: July 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: PAT Curriculum + Health Information
    Participants in the intervention group will receive the standard PAT curriculum plus information about healthy eating and an active lifestyle. This curriculum will be taught during up to 36 home visits in two years. Months 1-3 the visits are weekly; months 4-6 visits are biweekly; months 7-24 visits are monthly
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  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female, obese (BMI 30 -45 kg/m2),have at least one overweight or obese preschool child (>60th percentile) living in the home, plan to continue in the PAT program for two years, and able to give informed consent to participate in HEALTH.

Exclusion Criteria:

  • current pregnancy or plan to become pregnant in the next 24 months, inability to speak English, current enrollment in any weight loss program, a diagnosis and/or undergoing treatment for diabetes, cardiovascular disease, or eating disorders, or inability to exercise or engage in a walking program.
  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: NCT01567033

Locations
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63112
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Debra Haire Joshu, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01567033     History of Changes
Other Study ID Numbers: 201103147
Study First Received: March 14, 2012
Last Updated: June 2, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Diabetes
Obesity
Home visiting

ClinicalTrials.gov processed this record on September 01, 2015