# Cluster randomized trial of a mobile health intervention to achieve appropriate gestational weight gain in overweight/obese women

> **NIH NIH R01** · KAISER FOUNDATION RESEARCH INSTITUTE · 2020 · $558,600

## Abstract

Excessive gestational weight gain (GWG), defined as GWG above the current Institute of Medicine (IOM)
GWG guidelines is associated with adverse short and long-term health complications for women and their
infants. Overweight and obese women are at already at high risk of complications due to their elevated weight,
and excessive GWG further exacerbates their high risk of complications. Thus, there is an urgent need to help
reduce excessive GWG in this high-risk population. Traditional high-intensity interventions to improve GWG
among overweight and obese women have achieved success but are too time intensive for some women. In
addition, studies show women consider behavior change advice to be more persuasive if it comes from their
clinician, but clinicians have insufficient training on weight counseling. Thus, interventions aimed at reducing
excess GWG among overweight and obese women that are practical for both women and clinicians are
needed. Emerging evidence and our pilot work suggest that mobile health (mHealth) interventions for weight
management can be effective in pregnancy, but a large-scale randomized trial in the real-world clinical setting
is needed. We will conduct a cluster randomized controlled trial of 56 clinicians (caring for 2040 pregnant
overweight/obese women) randomized to usual care or usual care plus an mHealth intervention. We propose
an adaptive intervention that increases in intensity according to patients’ GWG in relation to the IOM
guidelines. Technology-based tools—including a mobile app, wireless “smart” scale, wearable activity tracker,
and diet tracking app—will enable convenient self-monitoring, feedback, and goal setting. These tools will
provide largely automated, real-time feedback to patients via text messaging and will transmit real-time GWG,
physical activity and diet data to a lifestyle coach and obstetric clinician. All patients of clinicians in the
intervention, receive the technology-based tools, automated text messages and weekly e-mails of core lifestyle
intervention sessions (Step 1). Step 2 is the addition of personalized text messages; and Step 3 is the addition
of personalized 1:1 telephone coaching sessions, with these latter 2 Steps reserved for patients who need
them. Clinicians in the intervention also receive training and tools embedded in the EHR to facilitate discussing
GWG with their patients. Our primary aim is to evaluate whether an adaptive mHealth intervention designed to
help overweight/obese women and their clinicians manage GWG will improve GWG in comparison to usual
care. Our secondary aim will evaluate whether an mHealth intervention improves postpartum weight retention
at 6 weeks, the proportion of infants with appropriate birthweight (<10th and >90th percentile) and infant
growth trajectory from birth to 12 months. We will evaluate the cost-effectiveness of the mHealth intervention
and possible adoption using a RE-AIM framework. If this mHealth intervention is proven effective, i...

## Key facts

- **NIH application ID:** 9932432
- **Project number:** 5R01DK118455-02
- **Recipient organization:** KAISER FOUNDATION RESEARCH INSTITUTE
- **Principal Investigator:** Monique Marie Hedderson
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $558,600
- **Award type:** 5
- **Project period:** 2019-05-20 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9932432

## Citation

> US National Institutes of Health, RePORTER application 9932432, Cluster randomized trial of a mobile health intervention to achieve appropriate gestational weight gain in overweight/obese women (5R01DK118455-02). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/9932432. Licensed CC0.

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