Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study

NCT06666257 | Not Yet Recruiting

• 2 other identifiers: 2767285P20GM109096
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

This single-arm pilot study will evaluate the feasibility and acceptability of a remotely delivered behavioral lifestyle intervention, adapted from the SmartMoms framework, to promote health gestational weight gain in pregnant women with overweight and obesity. Twelve to sixteen participants will receive weekly virtual motivational interview sessions with trained health coaches, review their daily weight data, step count, and continuous glucose monitoring data, and tailored guidance on physical activity and nutrition. Educational content will be delivered electronically, with peer support provided through a closed online group. A simulated (mock) control arm will be created post hoc from existing records for preliminary comparisons; all enrolled participants will receive the intervention.

Conditions

Pregnancies at Increased Risk for Excessive Gestational Weight Gain; Ecological Momentary Assessment and Intervention; Continuous Glucose Monitor

Keywords

Pregnancy; Obesity; Continuous Glucose Monitoring; Ecological Momentary Intervention; Gestational Weight Gain; Overweight

Outcome Measures

Primary Outcomes (3)

• Feasibility data of the modified EMI: AR-GEM Study - Recruitment and Retention

  Maternal recruitment and retention rates (total number of participants recruited and retained)

  continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months

• Feasibility data of the modified EMI: SmartMomsAR - Acceptability

  Acceptability scores from online intervention satisfaction questionnaires, 5 point Likert Scale system

  continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months

• Feasibility data of the modified EMI: SmartMomsAR - Protocol Adherence

  Adherence to study protocol via process measures. (Percentage of complete data points)

  continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months

Secondary Outcomes (4)

• Incidence of appropriate gestational weight gain per 2009 NASM guidelines.

  data is derived through study completion, an average of 6 months.

• Change in healthful lifestyle behaviors - HEI

  data is derived through study completion, an average of 6 months.

• Change in healthful lifestyle behaviors - Steps (Physical Activity)

  data is derived through study completion, an average of 6 months.

• Change in healthful lifestyle behaviors - Glycemic profile

  data is derived through study completion, an average of 6 months.

Study Arms (1)

Remote Weight & Step Monitoring + CGM

EXPERIMENTAL

Women will engage in the remote intervention resembling efforts used by the SmartMoms intervention, but adapted to the needs of Arkansas women while also wearing unblinded CGM devices providing insights to glycemic trends in response to lifestyle factors.

Behavioral: Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy

Interventions

Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy BEHAVIORAL

The intervention we are basing our adaptations on is a ecological momentary intervention, meaning it is integrated into participants daily lifestyle and schedule. Using an established framework for tracking daily body weight and physical activity, a gestational weight gain trajectory is estimated. Based on the data, recommendation prompts for exercise and diet will be discussed with participants during motivational interviewing. For the CGM piece, participants will wear unblinded CGM devices and have access to CGM linked app features that allow insights and reactivity to personal glycemic data

Remote Weight & Step Monitoring + CGM

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women less than 20 weeks of gestation at time of screening
• years of age
• BMI of 25 - 40 kg/m-2
• Expecting a singleton pregnancy
• Smartphone and/or reliable internet access
• Willing to be identifiable to other study participants in the study program .

You may not qualify if:

• Smoker
• Preexisting medical conditions that might be exacerbated by pregnancy (e.g., diabetes mellitus, chronic renal failure, hypertension, malignancies, seizure disorder, lupus, drug or alcohol abuse, serious psychiatric disorders)
• Current mental health or eating disorder
• Contraindication to exercise (OB/GYN release is obtained prior to consent)
• Conceived with assisted fertility treatments
• Medications during pregnancy known to influence fetal growth (e.g., thyroid hormone, glucocorticoids, insulin, oral hypoglycemic agents)
• Plans to move out of the state in the next 6 months following screening.

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

MeSH Terms

Conditions

Obesity; Gestational Weight Gain; Overweight

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Lisa T Jansen, PhD

  Arkansas Children's Hospital Research Institute; University of Arkansas for Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa T Jansen, PhD

CONTACT

5013646516; ltjansen@uams.edu

Sharon E Sanders, PhD, MPH, CHES

CONTACT

501-364-5118; SESanders@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This pilot study tests the feasibility of a single-arm, remotely delivered behavioral lifestyle intervention program for pregnant women with overweight and obesity. Modeled after the SmartMoms approach, the program combined weekly virtual health coach sessions with motivational interview techniques, daily weight and activity tracking, continuous glucose monitoring, and tailored education to support healthy gestational weight gain. A simulated control arm will be created from existing datasets for preliminary comparisons.

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 30, 2024
• Study Start: October 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Within 21 days of having IRB approval for the finalized phase II protocol (anticipated to be available 05/01/25)
• Access Criteria: Individual participant data (IPD) from this feasibility pilot study will be shared with qualified researchers conducting analyses that align with the study's objectives, specifically in relation to \[study-specific areas of interest, e.g., behavior modification in pregnancy, glucose metabolism, etc.\]. All data requests must include a detailed research proposal outlining planned analyses and the statistical methods. Proposals will be reviewed by the Principal Investigator and an independent review board for scientific validity, ethical considerations, and alignment with study objectives. A Data Sharing Agreement (DSA) must be signed prior to data release. Documents can be submitted via \[email/portal\], and requests will be reviewed within \[timeframe\]. Data will be shared via a secure, restricted-access repository.