Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
Study NCT ID:
NCT06666257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2024-10-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Sponsor:
Arkansas Children's Hospital Research Institute
Organization:
Study Overview
Official Title:
Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEM
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.
Detailed Description:
The purpose of this study is to assess the feasibility of delivering a remotely administered behavioral lifestyle intervention for pregnant women with overweight and obesity, adapted from the established SmartMoms framework, using a simulated (mock) control arm for comparison. This pilot study will enroll approximately 12-16 participants and will focus on evaluating feasibility, acceptability, and preliminary signals of impact to inform a future randomized controlled trial.
The intervention is tailored to the needs of women in Arkansas and aims to promote healthy gestational weight gain through motivational interviewing, physical activity promotion, education on dietary recommendations and self-monitoring. Participants will be encouraged to meet current pregnancy exercise guidelines (\>= 30 minutes of moderate-intensity activity on most, if not all days) and to follow a balanced diet consistent with caloric intake recommendations for appropriate gestational weight gain based on individual pre-pregnancy BMI.
Each participant will be provided with an internet connected bodyweight scal, and pedometer for daily self-monitoring. These devices will automatically transmit weight and step data to the study team. Participants will also wear a continuous glucose monitor (CGM) throughout their pregnancy to track temporal glucose patterns, which will be reviewed with the study's registered dietitian (RD) and health coaches.
Intervention delivery will include weekly virtual motivational interview sessions with a trained health coach. Sessions will review weight gain trajectory, dietary intake, physical activity patterns, and CGM data, and will provide tailored behavioral strategies for meeting gestational weight gain goals. Educational materials will be delivered electronically to participants' smartphones. A closed online forum will be available for peer support, following the SmartMoms framework.
The simulated control arm will be generated post hoc by matching trial participants to publicly available datasets based on gestational age, BMI category, and other relevant covariates. This mock control will serve only as a comparator for preliminary analyses; all enrolled participants will receive the active intervention.
The intervention will begin between 16-20 weeks' gestation and continue until delivery (20-24 weeks per participant). All motivational interviewing sessions will be delivered remotely, and participants will be trained individually on safe and effective use of study tools.
The intervention is tailored to the needs of women in Arkansas and aims to promote healthy gestational weight gain through motivational interviewing, physical activity promotion, education on dietary recommendations and self-monitoring. Participants will be encouraged to meet current pregnancy exercise guidelines (\>= 30 minutes of moderate-intensity activity on most, if not all days) and to follow a balanced diet consistent with caloric intake recommendations for appropriate gestational weight gain based on individual pre-pregnancy BMI.
Each participant will be provided with an internet connected bodyweight scal, and pedometer for daily self-monitoring. These devices will automatically transmit weight and step data to the study team. Participants will also wear a continuous glucose monitor (CGM) throughout their pregnancy to track temporal glucose patterns, which will be reviewed with the study's registered dietitian (RD) and health coaches.
Intervention delivery will include weekly virtual motivational interview sessions with a trained health coach. Sessions will review weight gain trajectory, dietary intake, physical activity patterns, and CGM data, and will provide tailored behavioral strategies for meeting gestational weight gain goals. Educational materials will be delivered electronically to participants' smartphones. A closed online forum will be available for peer support, following the SmartMoms framework.
The simulated control arm will be generated post hoc by matching trial participants to publicly available datasets based on gestational age, BMI category, and other relevant covariates. This mock control will serve only as a comparator for preliminary analyses; all enrolled participants will receive the active intervention.
The intervention will begin between 16-20 weeks' gestation and continue until delivery (20-24 weeks per participant). All motivational interviewing sessions will be delivered remotely, and participants will be trained individually on safe and effective use of study tools.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5P20GM109096 | NIH | None | https://reporter.nih.gov/quic… | View |