- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01567033
Healthy Eating and Active Living Taught at Home (HEALTH)
Translating a Weight Loss Intervention Through a National Home Visiting Program
Study Overview
Status
Intervention / Treatment
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?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63112
- Washington University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Intervention participants received HEALTH, which embedded a lifestyle intervention derived from DPP within the standard PAT curriculum
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index
Time Frame: Change in BMI from baseline to 24 months
|
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.
|
Change in BMI from baseline to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Waist Circumference
Time Frame: Change in waist circumference from baseline to 24 months
|
Waist circumference will be used to estimate abdominal adiposity which is associated with risk of Type 2 diabetes.
|
Change in waist circumference from baseline to 24 months
|
Blood Pressure
Time Frame: Change in blood pressure from baseline to 24 months
|
In accordance with American Heart Association guidelines, we will follow the recommendations and protocol for blood pressure measurement.
|
Change in blood pressure from baseline to 24 months
|
Survey
Time Frame: Changes in surveys from baseline to 24 months
|
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
|
Changes in surveys from baseline to 24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Debra Haire Joshu, PhD, Washington University School of Medicine
Publications and helpful links
General Publications
- Tabak RG, Morshed AB, Schwarz CD, Haire-Joshu D. Impact of a Healthy Weight Intervention Embedded Within a National Home Visiting Program on the Home Food Environment. Front Public Health. 2018 Jun 26;6:178. doi: 10.3389/fpubh.2018.00178. eCollection 2018.
- Haire-Joshu D, Schwarz CD, Steger-May K, Lapka C, Schechtman K, Brownson RC, Tabak RG. A Randomized Trial of Weight Change in a National Home Visiting Program. Am J Prev Med. 2018 Mar;54(3):341-351. doi: 10.1016/j.amepre.2017.12.012.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201103147
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on PAT Curriculum + Health Information
-
Montana State UniversityUSDA Beltsville Human Nutrition Research CenterCompleted
-
Victor CarrionUniversity of South Carolina; Iowa State University; University of San Diego; Pure...CompletedStress, Psychological | Trauma, Psychological
-
University of MinnesotaJohns Hopkins University; Eunice Kennedy Shriver National Institute of Child... and other collaboratorsCompletedTraining | Health Knowledge, Attitudes, PracticeUnited States
-
University Hospital of SplitCroatian Science FoundationCompletedUnderstanding Cochrane Systematic ReviewsCroatia
-
VA Office of Research and DevelopmentRegenstrief Institute, Inc.CompletedCardiovascular Diseases | Heart Failure | Diabetes Mellitus | Asthma | OsteoporosisUnited States
-
Pacific Institute for Research and EvaluationNational Institute of Mental Health (NIMH)Completed
-
Taipei Medical University WanFang HospitalNo longer availableValuable Suggestions to Improve Health Care Quality Transparent and Accessible Medical Care
-
University of PennsylvaniaCompletedBehavioral Variant of Frontotemporal Dementia | Caregiver Stress SyndromeUnited States
-
Thomas Jefferson UniversityNational Cancer Institute (NCI)TerminatedHypertension | Diabetes Mellitus | Diabetes
-
Charles Drew University of Medicine and ScienceLos Angeles County Department of Public HealthWithdrawnHealth Equity | Youth Participatory Action Research | Youth Mental Health