Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity

NCT04724330 | Completed

• 2 other identifiers: IRB00255969R18DK122416-01A1
• Study Type: interventional
• Target: 534
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy Weight Gain; Postpartum Weight Retention; Childhood Obesity; Gestational Diabetes; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Total gestational weight gain

  Difference between weight (lbs) at 37 weeks and baseline first trimester weight, measured prior to 15 weeks gestation.

  At 37 weeks in pregnancy

Secondary Outcomes (5)

• Number of participants who gained excess weight

  At 37 weeks in pregnancy

• Incidence of gestational diabetes mellitus

  At 37 weeks in pregnancy

• Postpartum weight retention

  6 months after delivery

• Infant weight

  At 6 months of age

• Proportion of low birth weight infants

  At time of birth/delivery

Study Arms (2)

Healthy for Two/Healthy for You (H42/H4U)

EXPERIMENTAL

Those assigned to the intervention group will receive the H42/H4U health coaching intervention during pregnancy and 12 weeks postpartum.

Behavioral: Healthy for Two/Healthy for You

Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP)

NO INTERVENTION

Those assigned to the Usual Care comparison group, mHIP, will receive typical, evidence- and guideline-based experience in the prenatal care clinics.

Interventions

Healthy for Two/Healthy for You BEHAVIORAL

\~10 month (early pregnancy to 12 weeks postpartum), remotely-delivered, behavioral lifestyle intervention including health coach contacts (via phone, videoconference, and email/MyChart) and an interactive web-based platform.

Also known as: H42/H4U

Healthy for Two/Healthy for You (H42/H4U)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18
• Singleton pregnancy
• ≤15 weeks gestation with documented prenatal weight and height in electronic health record
• Body mass index ≥ 25.0 kg/m2
• English-speaking
• Has smartphone, laptop or tablet and willing to use it for this study
• Has email address and willing to use for this study

You may not qualify if:

• BMI \<25 kg/m2
• Multiple fetuses
• History of pre-gestational Type 1 or Type 2 diabetes or taking diabetes medication for treatment of diabetes prior to first prenatal visit
• Prior history of severe preeclampsia, pre-term birth (\< 32 weeks gestation)
• Poorly controlled blood pressure (\> 160/100 mmHg)
• Substance use disorder or positive urine toxicology (except for THC) for illicit substances (screening done as part of routine care)
• Psychiatric hospitalization in last 12 months or diagnosis of severe mental illness that is not well controlled
• Active diagnosis of an eating disorder
• Unable to walk 1 block without pain or shortness of breath
• No email address
• Unable to speak or read in English
• Planning to move in next 12 months

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Johns Hopkins Health System and University

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• Drabo EF, McKinney CD, Martin LM, Nair D, Coughlin JW, Chen T, Borahay MA, Wang NY, Bennett WL. Protocol for the economic evaluation of the "Healthy for Two/Healthy for You" pragmatic lifestyle intervention in prenatal care to reduce gestational weight gain and gestational diabetes mellitus. Contemp Clin Trials. 2025 Sep;156:108037. doi: 10.1016/j.cct.2025.108037. Epub 2025 Jul 31.

  PMID: 40752820 RESULT

• Bennett WL, Coughlin JW, Henderson J, Martin S, Yazdy GM, Drabo EF, Showell NN, McKinney C, Martin L, Dalcin A, Sanders R, Wang NY. Healthy for Two/Healthy for You: Design and methods for a pragmatic randomized clinical trial to limit gestational weight gain and prevent obesity in the prenatal care setting. Contemp Clin Trials. 2022 Feb;113:106647. doi: 10.1016/j.cct.2021.106647. Epub 2021 Dec 8.

  PMID: 34896296 RESULT

MeSH Terms

Conditions

Gestational Weight Gain; Pediatric Obesity; Diabetes, Gestational; Overweight; Obesity

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Wendy L Bennett, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 26, 2021
• Study Start: March 15, 2021
• Primary Completion: January 31, 2025
• Study Completion: June 25, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)