Clinical Trials Logo

Clinical Trial Summary

This project evaluates the effectiveness of an evidence-based intervention (HEALTH) to prevent weight gain and promote weight loss when disseminated and implemented in real-world settings, through Parents as Teachers. To enhance the impact of HEALTH, the study also evaluates implementation outcomes from the training curriculum (implementation strategy) and external validity when HEALTH is implemented within this national home visiting organization. This partnership has potential for significant impact on obesity and chronic diseases such as cardiovascular disease and diabetes.


Clinical Trial Description

Excessive weight gain among young adult women age 18-35 years is an alarming and overlooked trend that must be addressed to reverse the epidemics of obesity and chronic disease. During this vulnerable period women tend to gain disproportionally large amounts of weight compared to men and other life periods. A lifestyle modification intervention (HEALTH) that prevented weight gain, promoted sustained weight loss, and reduced waist circumference was developed in partnership with Parents as Teachers (PAT), a national home visiting, community based organization with significant reach in this population. PAT provides parent-child education and services free-of-charge to nearly 170,000 families through up to 25 free home visits per year until the child enters kindergarten. This study will extend these findings with a pragmatic cluster randomized controlled trial to evaluate dissemination and implementation of HEALTH across three levels (mother, parent educator, PAT site) to achieve widespread impact. The pragmatic cluster randomized controlled trial will evaluate HEALTH and the HEALTH training curriculum (implementation strategy) on weight among mothers with overweight and obesity across the US (N= 252 HEALTH; N= 252 usual care). Parent educators from 28 existing PAT sites (14 HEALTH, 14 usual care) will receive the HEALTH training curriculum through the PAT National Center, using PAT's existing training infrastructure, as a continuing education opportunity. An extensive evaluation, guided by RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) will determine implementation outcomes (acceptability, adoption, appropriateness, feasibility, fidelity, and adaptation) at the parent educator level. The Conceptual Framework for Implementation research will characterize determinants that influence HEALTH dissemination and implementation at three levels: mother, parent educator, PAT site to enhance external validity (reach and maintenance) and population level impact. The findings from this innovative study will have significant potential to help reverse the trend of excessive weight gain among young adult women, a critical priority target in battling the epidemics of obesity and chronic disease, by reaching women with an evidence-based intervention nation-wide. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03758638
Study type Interventional
Source Washington University School of Medicine
Contact Rachel G Tabak, PhD, RD
Phone 3149350153
Email rtabak@wustl.edu
Status Not yet recruiting
Phase Phase 3
Start date January 2019
Completion date September 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT03714646 - Beta Glucan and Acetate Production N/A
Recruiting NCT03255005 - Endomina Controlled Study N/A
Enrolling by invitation NCT03063606 - Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment Phase 2/Phase 3
Completed NCT03317587 - Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE) N/A
Terminated NCT03299881 - Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss N/A
Active, not recruiting NCT03610958 - Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss. N/A
Completed NCT02235961 - Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects Phase 1
Completed NCT03195712 - Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers N/A
Completed NCT00341406 - Fat Cell Size in Insulin Resistance
Not yet recruiting NCT03470272 - Effects of Red Light LED Therapy on Body Contouring N/A
Recruiting NCT03627104 - Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity N/A
Recruiting NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Active, not recruiting NCT02918279 - Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity Phase 3
Completed NCT00494767 - Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs Phase 1
Recruiting NCT03338296 - Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 Years Phase 4