Clinical Trials Logo

Clinical Trial Summary

Healthy for Two, Healthy for You (H42/H4U) is an innovative evidence-based pregnancy/postpartum health coach intervention that is remotely-delivered (phone coaching using motivational interviewing, web-based platform, mobile phone behavioral tracking). The aim of this randomized controlled trial (RCT) is to embed H42/H4U into Johns Hopkins prenatal care clinics that serve a racially and economically diverse population, leveraging existing staff as trained health coaches to test its effectiveness and implementation. The investigators hypothesize that women in the H42/H4U arm will have lower gestational weight gain and lower rates of gestational diabetes, without an increase in low birth weight infants, and that implementation into the investigators' prenatal care clinics will be feasible and scalable.


Clinical Trial Description

Despite two decades of public health efforts to combat obesity, rates continue to rise and racial disparities persist. There is an urgent need to re-focus obesity prevention efforts onto young adults, particularly reproductive age women. 23% of women (vs. 13% of men) gain ≥20 kg from age 18 to 55 years, with the highest weight gain in African American women who gain > 1kg/year. Importantly, weight gain of ≥20 kg is associated with development of type 2 diabetes (DM), other obesity-related comorbidities and greater mortality. For women who become pregnant, pregnancy provides an important opportunity for obesity and DM prevention, as excessive gestational weight gain (GWG) and pregnancy complications [e.g. gestational diabetes (GDM)], increase future DM risk. Promoting healthy GWG through behavioral interventions may prevent these pregnancy complications, but importantly has great potential for long-term, sustainable benefits to prevent postpartum weight retention (PPWR) and future obesity and DM, in women and the women's children. With the publication of the LIFE-Moms consortium's results, there is now strong evidence from efficacy trials showing that limiting GWG is achievable and associated with improved exercise and dietary behaviors. Several notable research gaps and next steps have emerged from the LIFE-Moms' studies, which the investigators address in this pragmatic trial. Because these studies were designed to test the efficacy of behavioral weight management on GWG, interventions were resource intensive (i.e. in-person counseling and with limited online and mobile technologies), without a focus on program implementation and sustainability in routine prenatal care settings and lacking intervention in the vulnerable postpartum period. To address these critical evidence gaps and reduce obesity associated with the pregnancy/postpartum periods, the next step is to integrate and test an evidence-based lifestyle intervention in pregnancy and postpartum that utilizes remote delivery of counseling, enables self-monitoring by patients using mobile and online technologies and supports obstetric providers and clinics to optimize care for women at high risk for obesity and future DM. The investigators' experienced team created and tested Healthy for Two / Healthy for You (H42/H4U). H42/H4U is an innovative evidence-based pregnancy/postpartum health coaching intervention that is remotely-delivered (phone coaching using motivational interviewing + web-based platform + mobile phone behavioral tracking). The aim of this R18 pragmatic randomized controlled trial (RCT) is to embed H42/H4U into prenatal care clinics that serve a racially and economically diverse population, leveraging existing staff as trained health coaches and community health workers (CHWs), to test its effectiveness and implementation. The investigators hypothesize that women in the H42/H4U arm will have lower GWG and lower rates of GDM, without an increase in low birth weight infants, and that implementation into the investigators' prenatal care clinics will be feasible and scalable. The investigators will rigorously test this hypothesis through the following Specific Aims: Aim 1. Test the effectiveness of H42/H4U integrated into prenatal care compared with Usual Care among 380 pregnant and postpartum women enrolled from 6 prenatal clinics on: A. Primary outcome: GWG (37 week minus baseline pregnancy [≤15 week gestation] weight) B. Maternal secondary outcomes: Proportion with excessive GWG; GDM incidence; PPWR at 6 months after delivery C. Infant secondary outcomes: Weight at birth, 4 and 6 months. D. Other outcomes: Maternal health behaviors (diet, physical activity, breastfeeding); Maternal wellness (depression, sleep and stress) Aim 2. Assess organizational factors that impact the implementation of the intervention into prenatal care clinics, including costs of intervention delivery and provider and staff satisfaction to inform future dissemination. A. Provider and staff perspectives, including satisfaction, workflow barriers and potential for sustainability, using qualitative semi-structured interviews (n=15 at baseline and end of study). B. Cost analysis to assess intervention delivery costs and the return on investment (ROI) of H42/H4U. This study will advance a potentially powerful, prenatal care-based strategy to reduce obesity in young adult childbearing women and thereby the intergenerational effects on the women's children. The investigators' interdisciplinary team brings together engaged academic and community-based obstetricians, the investigators' health system's population health program and researchers with experience in developing, testing and implementing behavioral interventions in both pregnant and non-pregnant adults in real world settings to enable wide dissemination. Ultimately, the investigators' goal is to design and produce an effective and scalable behavioral strategy, integrated into clinical practice that will: 1) reduce excessive GWG and its associated pregnancy complications, 2) reduce future obesity, DM and other obesity-related complications in mothers and the mothers' children, and 3) ensure high quality care delivery that prevents obesity and DM through a population health approach to prenatal care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04724330
Study type Interventional
Source Johns Hopkins University
Contact Wendy L Bennett, MD, MPH
Phone 4105026081
Email wendy.bennett@jhmi.edu
Status Recruiting
Phase N/A
Start date March 15, 2021
Completion date August 31, 2025

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03994419 - PErioperAtive CHildhood ObesitY
Recruiting NCT05354245 - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL) N/A
Completed NCT03602001 - Attentive Eating for Weight Loss N/A
Recruiting NCT06269159 - The Power of 24-hour: Co-designing Intervention Components
Completed NCT03377244 - Healthy Body Healthy Souls in the Marshallese Population N/A
Completed NCT02996864 - Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II N/A
Terminated NCT03914066 - A Group-based Treatment of Overweight and Obesity in Primary Care N/A
Completed NCT04647149 - Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity N/A
Completed NCT03685656 - Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers N/A
Completed NCT05051579 - A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities Phase 2
Completed NCT04611477 - Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals N/A
Active, not recruiting NCT05330247 - Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study N/A
Completed NCT03599115 - Effects of Inhibitory Control Training in Eating Behaviors N/A
Recruiting NCT05938894 - Train Your Brain - Executive Function N/A
Recruiting NCT06094231 - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study N/A
Recruiting NCT05987306 - A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss N/A
Completed NCT03792685 - Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention N/A
Completed NCT05055362 - Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study N/A
Completed NCT04520256 - Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy Phase 2/Phase 3
Completed NCT04979234 - A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome N/A