Health Coaching for Pregnancy Weight Gain
Recruiting in Palo Alto (17 mi)
Overseen byWendy Bennett, MD,MPH
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Must not be taking: Insulin
Disqualifiers: Type 1 diabetes, Multiple fetuses, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
The purpose of this study is to compare the effectiveness of H42-HV integrated into home visiting compared with usual home visiting services in reducing postpartum weight retention (difference between pre-pregnancy weight and weight at 6 months postpartum) among pregnant and postpartum people. The intervention is tailored for Black and Latinx pregnant and postpartum people and, ultimately, aims to address inequities in cardiometabolic health.
Will I have to stop taking my current medications?
The trial does not specify whether you need to stop taking your current medications. However, if you have Type 1 diabetes or are taking insulin, you cannot participate in the trial.
What data supports the effectiveness of the treatment Healthy for Two-Home Visiting (H42-HV) for pregnancy weight gain?
Research on home visiting programs, like the Nurse-Family Partnership, shows they can improve maternal and child health by helping mothers with prenatal care and planning for the future. These programs have been successful in reducing child injuries and helping mothers become more self-sufficient, which suggests they may also support healthy pregnancy weight management.12345
Is the Health Coaching for Pregnancy Weight Gain program safe for humans?
The available research on home visiting programs, which are similar to the Health Coaching for Pregnancy Weight Gain program, suggests they are generally safe and focus on promoting health and preventing issues like obesity in children. However, specific safety data for this exact program is not provided in the available studies.16789
How is the Healthy for Two-Home Visiting (H42-HV) treatment different from other treatments for managing pregnancy weight gain?
The Healthy for Two-Home Visiting (H42-HV) treatment is unique because it involves personalized health coaching integrated into home visits, focusing on lifestyle changes to manage pregnancy weight gain, unlike other treatments that may rely solely on information or telephone-based coaching.1011121314
Eligibility Criteria
This trial is for Black and Latinx pregnant individuals with a pre-pregnancy BMI of 25 or higher, less than 33 weeks along, who speak English or Spanish. They must be enrolled in a home visiting program and willing to participate in health coaching. Excluded are those with Type 1 diabetes on insulin, multiple pregnancies, mobility issues, planned relocation within a year, active substance abuse (except marijuana), or recent psychiatric hospitalization.Inclusion Criteria
Completion of screening and baseline data collection
Enrolled in participating home visiting program
Able to provide informed consent
See 5 more
Exclusion Criteria
Planning to relocate from area during next 1 year
Active eating disorder
Not cleared by the study's clinicians or home visiting program staff
See 6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive health coaching calls, use a web-based app for learning activities and goal setting, track health behaviors, and perform weekly self-weighing from 20-33 weeks gestation through 6 months postpartum
8-11 months
Regular phone or Zoom calls, with possible in-person contact during home visits
Follow-up
Participants are monitored for changes in postpartum weight retention, physical activity, breastfeeding practices, sleep habits, depression, smoking habits, diet, healthcare utilization, and social support
6 months postpartum
Assessments at baseline, 37 weeks gestation, 2, 4, and 6 months postpartum
Treatment Details
Interventions
- Healthy for Two-Home Visiting (H42-HV) (Behavioural Intervention)
- "Usual Home Visiting Plus" (mHIP-HV) (Behavioural Intervention)
Trial OverviewThe study compares the 'Healthy for Two-Health Coaching' integrated into regular home visits against standard services alone. It focuses on reducing weight retention six months postpartum among participants to improve cardiometabolic health outcomes.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Healthy for Two-Health Coaching (H42)Experimental Treatment1 Intervention
Those assigned to the intervention group will receive the 8 to 11 month H42 health coaching intervention in addition to usual home visiting and usual prenatal and postpartum care clinical services. Intervention duration will depend on the participant's gestational age at the of enrollment. Participants can be enrolled as early in pregnancy as 20 weeks gestation and as late as 33 weeks gestation. All participants would be enrolled for 6 months postpartum. Therefore, the minimum time in the intervention would be 8 months and maximum would be 11 months.
Group II: Maintain Health in Pregnancy and Postpartum (mHIPP)Active Control1 Intervention
Those assigned to the "usual home visiting plus" comparison group, called maintain health in pregnancy and postpartum (mHIPP), will receive the typical, evidence-based experience in participants' home visiting program in addition to the participants' usual prenatal and postpartum care clinical services. In addition, the investigators will provide a brief (less than 5 minutes) maternal warning signs educational video that is available in English or Spanish. The video was developed for a home visiting client audience and is publicly available, https://mdmom.org/warningsigns.
Healthy for Two-Home Visiting (H42-HV) is already approved in United States for the following indications:
🇺🇸 Approved in United States as Healthy for Two-Home Visiting for:
- Postpartum weight retention prevention
- Cardiometabolic health improvement
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins School of NursingBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
References
Birth-Related Outcomes for Second Children Following Home Visiting Program Enrollment for New Parents of First Children. [2022]Home visiting (HV) programs aim to promote child and family health through perinatal intervention. HV may benefit second children through improving subsequent pregnancy and birth outcomes. However, HV impacts on birth outcomes of second children have not been examined in a naturalistic setting.
Client experiences in a prenatal home visiting program: A prenatal care coordination program evaluation. [2020]Prenatal home visiting programs are a strategy to promote positive birth outcomes. Ongoing evaluations of these programs are important to promote fidelity and quality. The goal of this program evaluation was to gain clients' perspectives of their experiences in one Wisconsin Health Department's Prenatal Care Coordination program including: (a) why clients entered the program, (b) whether client expectations were met, and (c) how expectations impacted client retention.
The nurse-family partnership: An evidence-based preventive intervention. [2022]Pregnancy and the early years of the child's life offer an opportune time to prevent a host of adverse maternal, child, and family outcomes that are important in their own right, but that also reflect biological, behavioral, and social substrates in the child and family that affect family formation and future life trajectories. This article summarizes a 27-year program of research that has attempted to improve early maternal and child health and future life options with prenatal and infancy home visiting by nurses. The program is designed for low-income mothers who have had no previous live births. The home-visiting nurses have three major goals: to improve the outcomes of pregnancy by helping women improve their prenatal health, to improve the child's health and development by helping parents provide more sensitive and competent care of the child, and to improve parental life course by helping parents plan future pregnancies, complete their education, and find work. The program has been tested in three separate large-scale, randomized controlled trials with different populations living in different contexts. Results from these trials indicate that the program has been successful in achieving two of its most important goals: (a) the improvement of parental care of the child as reflected in fewer injuries and ingestions that may be associated with child abuse and neglect and better infant emotional and language development; and (b) the improvement of maternal life course, reflected in fewer subsequent pregnancies, greater work-force participation, and reduced dependence on public assistance and food stamps. The impact on pregnancy outcomes is equivocal. In the first trial, the program also produced long-term effects on the number of arrests, convictions, emergent substance use, and promiscuous sexual activity of 15-year-old children whose nurse-visited mothers were low-income and unmarried when they registered in the study during pregnancy. In general, the impact of the program was greater on those segments of the population at greater risk for the particular outcome domain under examination. Since 1996, the program has been offered for public investment outside of research contexts. Careful attention has been given to ensuring that organizational and community contexts are favorable for development of the program, to providing excellent training and guidance to the nurses in their use of the program's visit-by-visit guidelines, to monitoring the functioning of the program with a comprehensive clinical information system, and to improving the performance of the programs over time with continuous improvement strategies.
Clinician Racial Biases: Preliminary Investigation on Predictors of Poor Therapeutic Alliance and Retention in Home Visiting Intervention Program. [2023]Home visiting programs are effective in improving maternal-child health, and higher therapeutic alliance is associated with improved program retention and outcomes. Black, single, low-income mothers have a higher risk for poorer health outcomes in pregnancy and postpartum and for early termination of therapeutic services.
Prenatal and infancy home visitation by nurses: recent findings. [2022]This article describes a 20-year program of research on the Nurse Home Visitation Program, a model in which nurses visit mothers beginning during pregnancy and continuing through their children's second birthdays to improve pregnancy outcomes, to promote children's health and development, and to strengthen families' economic self-sufficiency. The results of two randomized trials (one in Elmira, New York, and the second in Memphis, Tennessee) are summarized, and an ongoing trial in Denver, Colorado, is briefly described. Results of the Elmira and Memphis trials suggest the following: The program benefits the neediest families (low-income unmarried women) but provides little benefit for the broader population. Among low-income unmarried women, the program helps reduce rates of childhood injuries and ingestions that may be associated with child abuse and neglect, and helps mothers defer subsequent pregnancies and move into the workforce. Long-term follow-up of families in Elmira indicates that nurse-visited mothers were less likely to abuse or neglect their children or to have rapid successive pregnancies. Having fewer children enabled women to find work, become economically self-sufficient, and eventually avoid substance abuse and criminal behavior. Their children benefitted too. By the time the children were 15 years of age, they had had fewer arrests and convictions, smoked and drank less, and had had fewer sexual partners. The program produced few effects on children's development or on birth outcomes, except for children born to women who smoked cigarettes when they registered during pregnancy. The positive effects of the program on child abuse and injuries to children were most pronounced among mothers who, at registration, had the lowest psychological resources (defined as high levels of mental health symptoms, limited intellectual functioning, and little belief in their control of their lives). Generally, effects in Elmira were of greater magnitude and covered a broader range of outcomes than in Memphis, perhaps because of differences between the populations studied, community contexts, or a higher rate of turnover among home visitors in Memphis than in Elmira. The article concludes that the use of nurses as home visitors is key; that services should be targeted to the neediest populations, rather than being offered on a universal basis; that clinically tested methods of changing health and behavioral risks should be incorporated into program protocols; and that services must be implemented with fidelity to the model tested if program benefits found in scientifically controlled studies are to be reproduced as the program is replicated in new communities.
Parental support in promoting children's health behaviours and preventing overweight and obesity - a long-term follow-up of the cluster-randomised healthy school start study II trial. [2023]Effects of obesity prevention interventions in early childhood are only meaningful if they are sustained over time, but long-term follow-up studies are rare. The school-based cluster-randomised Healthy School Start (HSS) trial aimed at child health promotion and obesity prevention through parental support was carried out in 31 pre-school classes (378 families) in disadvantaged areas in Sweden during 2012-2013. Post-intervention results showed intervention effects on intake of unhealthy foods and drinks, and lower BMI-sds in children with obesity at baseline. This study aimed to evaluate the long-term effectiveness 4 years post-intervention.
Pediatric Primary Care-Based Obesity Prevention for Parents of Preschool Children: A Pilot Study. [2018]The Healthy Homes/Healthy Kids Preschool (HHHK-Preschool) pilot program is an obesity prevention intervention integrating pediatric care provider counseling and a phone-based program to prevent unhealthy weight gain among 2- to 4-year-old children at risk for obesity (BMI percentile between the 50th and 85th percentile and at least one overweight parent) or currently overweight (85th percentile ≤ BMI
A controlled, longitudinal study of home visits compared to telephone contacts to prevent early childhood caries. [2022]Home visits (HV) provide excellent opportunities for health promotion.
Sustained health home visiting can improve families' social support and community connectedness. [2017]Home visiting (HV) is a strategy used internationally to address the multiple needs of infants and families at risk of suboptimal health and developmental outcomes.
Protocol for a randomized controlled trial of a specialized health coaching intervention to prevent excessive gestational weight gain and postpartum weight retention in women: the HIPP study. [2021]Pregnancy is a time of significant physiological and physical change for women. In particular, it is a time at which many women are at risk of gaining excessive weight. We describe the rationale and methods of the Health in Pregnancy and Post-birth (HIPP) Study, a study which aims primarily to determine the effectiveness of a specialized health coaching (HC) intervention during pregnancy, compared to education alone, in preventing excessive gestational weight gain and postpartum weight retention 12 months post birth. A secondary aim of this study is to evaluate the mechanisms by which our HC intervention impacts on weight management both during pregnancy and post birth.
Piloting a Telephone Based Health Coaching Program for Pregnant Women: A Mixed Methods Study. [2020]Objectives Get Healthy in Pregnancy (GHiP) is a telephone based lifestyle coaching service for pregnant women, in New South Wales, Australia. GHiP had two service options; a telephone-based health coaching program consisting of up to 10 calls and information only (including one call). This study sought to compare the outcomes of the two GHiP options, to determine the characteristics of women likely to use the service and to explore the feedback from women and health professionals. Methods A pragmatic stratified clustered randomised controlled trial was conducted. Two metro and three rural hospitals were randomised into health coaching or information only arms. Self-reported measures of height and weight and health behaviours (dietary and physical activity) were collected at baseline and 36 weeks gestation. Process evaluation included descriptive analysis of routine program data, and semi-structured interviews with participants and health professionals. Results Of 3736 women screened, 1589 (42.5%) were eligible to participate, and of those eligible, 923 (58.1%) were recruited. More women in the health coaching arm gained weight within the target range for their BMI at 36 weeks gestation (42.9%) compared with information only (31.9%). Women found GHiP to be useful and supportive and midwives and doctors said that it facilitated conversations about weight with pregnant women. Conclusions for Practice Telephone-based lifestyle programs integrated with routine clinical care show promise in helping pregnant women achieve healthy gestational weight gain, but in this case was not significantly different from one information telephone call. Strong positive feedback suggests that scaled-up service delivery would be well received. TRIAL REGISTRATION: ACTRN12615000397516 (retrospectively registered).
Pragmatic cluster randomised trial of a free telephone-based health coaching program to support women in managing weight gain during pregnancy: the Get Healthy in Pregnancy Trial. [2023]Excessive gestational weight gain can result in poor maternal and child health outcomes. Estimates from single studies indicate the prevalence of excessive gestational weight gain in Australia could lie between 38 and 67 %. The risk of excessive weight gain can be reduced through healthy eating and exercise. We describe the rationale and methods of the Get Healthy in Pregnancy Service, a trial service which aims to support women in achieving appropriate gestational weight gain through an existing telephone-based health coaching service.
Personalized health planning with integrative health coaching to reduce obesity risk among women gaining excess weight during pregnancy. [2022]Health coaching is an emerging behavioral intervention to improve outcomes in chronic disease management and prevention; however, no studies have investigated its utility in postpartum women who have gained excess weight during pregnancy. A 32-year-old primigravida woman who was overweight at conception and gained 23 lbs more than Institute of Medicine recommendations for her pre-pregnancy body mass index participated in a 6-month personalized health planning with integrative health coaching (PHPIHC) intervention. The intervention included a baseline health risk assessment review with a healthcare provider and eight biweekly, 30-minute telephonic health coaching sessions. The participant demonstrated improvement in physical activity, energy expenditure, knowledge, and confidence to engage in healthpromoting behaviors. Although the participant did not reach the target weight by completion of the health coaching sessions, follow up 8 months later indicated she achieved the target goal (within 5% of prepregnancy weight). This case report suggests that PHP-IHC can support postpartum women in returning to pre-pregnancy weight after gaining excess gestational weight. Future research and clinical trials are needed to determine the best timing, length, and medium (online, in-person, telephonic) of PHP-IHC for postpartum women.
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. [2023]To compare the effect of Healthy for Two/Healthy for You (H42/H4U), a health coaching program, in prenatal care clinics that serve a racially and economically diverse population, on total gestational weight gain (GWG) (vs. usual care). We hypothesize that compared to usual prenatal care, intervention participants will have lower GWG and lower rates of gestational diabetes mellitus (GDM).