Healthy Eating and Active Living Taught at Home (HEALTH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01567033
First received: March 14, 2012
Last updated: April 16, 2013
Last verified: April 2013
  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

Resource links provided by NLM:


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: August 2014 (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
Detailed Description:

The primary aim is to test Healthy Eating & Active Living Taught at Home (HEALTH), which adapts and integrates the Diabetes Prevention Program lifestyle intervention within Parents As Teachers (PAT), a national home visiting program on which many high needs populations rely for parent-child information and services. Specific aims 1 and 2 will evaluate the impact of HEALTH on lifestyle behaviors and weight of obese mothers and their overweight/obese preschool child across multiple PAT regions. Specific aims 3 and 4 will address elements of external validity through evaluation of factors that impact the uptake of HEALTH within the PAT organization.

Specific aim 1. Using a group randomized, nested cohort design, evaluate the impact of HEALTH on obese women (BMI 30-45 kg/m2; age 18-45 y old) randomized to either control regions receiving the standard PAT program, or intervention regions receiving HEALTH.

Hypothesis 1.1 The primary hypothesis is at the conclusion of the study, when compared to the control group, participants in HEALTH will achieve a 7% weight loss at 12 months and maintain a 5% weight loss at 24 months, which will be at least two-fold greater than that achieved in the control group.

The secondary hypotheses are that at the conclusion of the study, when compared to the control group, participants in HEALTH will significantly:

Hypothesis 1.2 Improve clinical outcomes of waist circumference and systolic and diastolic blood pressure; Hypothesis 1.3 Improve knowledge of evidence-based lifestyle behaviors and quality of life; Hypothesis 1.4 Decrease caloric intake Hypothesis 1.5 Increase moderate intensity walking.

Specific aim 2. The secondary aim is to determine whether improvements in 'mother to child' behaviors of HEALTH participants will explain all or part of changes in the weight trajectory of the participant's overweight (>85th percentile) or obese (>95th percentile) preschool child. The hypotheses are that at the conclusion of the study, when compared to the control group:

Hypothesis 2.1 There will be a significantly greater proportion of participants in the HEALTH group who improve child feeding practices with their preschool child; Hypothesis 2.2 There will be a significantly greater proportion of preschool children in the HEALTH group who maintain or reduce their weight as measured by BMI Z-score.

Specific aim 3. The aim is to assess and provide information on the external validity of HEALTH to enhance research translation (e.g. reach and representativeness, program implementation or adaptation, decision making outcomes, and maintenance or institutionalization).

Question 3.1 Are HEALTH adopters representative of control PAT participants and parent educators? Question 3.2 Are HEALTH parent educators effectively trained to deliver the intervention? Question 3.3 Is HEALTH implemented as designed or adapted for content, consistency, or intensity? Question 3.4 Is HEALTH maintained as an institutionalized component of PAT practice? Specific aim 4. The aim is to determine the cost-utility of HEALTH in decreasing obesity and risk for diabetes from two perspectives: the service provider and state health agencies.

Question 4.1 Is the implementation and maintenance of HEALTH effective from a cost-utility perspective for the participants enrolled in the program and the agencies considering implementing these programs? Question 4.2 Is HEALTH effective in improving health quality, from the perspective of state agencies considering funding decisions for this and similar programs?

  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

Contacts
Contact: Debra Haire-Joshu, PhD 314-935-3963 djoshu@gwbmail.wustl.edu
Contact: Christina Lapka, MS 314-935-3064 clapka@wustl.edu

Locations
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63112
Contact: Debra Haire Joshu, PhD    314-935-3963    djoshu@gwbmail.wustl.edu   
Principal Investigator: Debra Haire Joshu, PhD         
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: April 16, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014