Pregnancies at Increased Risk for Excessive Gestational Weight GainGEMNCT06666257
Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
A study testing Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy in people with Pregnancies at Increased Risk for Excessive Gestational Weight Gain and Ecological Momentary Assessment and Intervention, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancies at Increased Risk for Excessive Gestational Weight Gain, Ecological Momentary Assessment and Intervention, Continuous Glucose Monitor
- What is being tested?
- Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women less than 20 weeks of gestation at time of screening
- 18-45 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Arkansas Children's Research Institute - Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Elizabeth Hayes, Recruitment Coordinator, 501-364-3309, ACNCStudies@uams.edu
Lisa T Jansen, PhD
About this study
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.
Read the 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.
- Conditions
- Pregnancies at Increased Risk for Excessive Gestational Weight Gain, Ecological Momentary Assessment and Intervention, Continuous Glucose Monitor
- Being tested
- Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy
- Keywords
- Pregnancy, Obesity, Continuous Glucose Monitoring, Ecological Momentary Intervention, Gestational Weight Gain, Overweight
- Medical subject headings
- Obesity, Gestational Weight Gain, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in PregnancyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility data of the modified EMI: AR-GEM Study - Recruitment and Retention
Maternal recruitment and retention rates (total number of participants recruited and retained)
Measured: 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
Measured: 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)
Measured: 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.
Frequencies (percentage) of appropriate gestational weight gain incidence. Maternal weight (lbs) over time.
Measured: data is derived through study completion, an average of 6 months.
Change in healthful lifestyle behaviors - HEI
Change scores for healthy eating index (HEI)
Measured: data is derived through study completion, an average of 6 months.
Change in healthful lifestyle behaviors - Steps (Physical Activity)
Change scores for physical activity counts (steps) as assessed commercial accelerometer.
Measured: data is derived through study completion, an average of 6 months.
Change in healthful lifestyle behaviors - Glycemic profile
Summary of glycemic profile data (mg/dL) as assessed by CGM.
Measured: data is derived through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Mar 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancies at Increased Risk for Excessive Gestational Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Lisa Jansen, Arkansas Children's Hospital Research Institute
- Investigators
- Lisa T Jansen, PhD, Principal investigator, Arkansas Children's Hospital Research Institute; University of Arkansas for Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666257
- Sponsor's protocol ID
- 276728
- Other IDs
- 5P20GM109096
- Acronym
- GEM
- Status last verified
- May 2026
- First submitted
- 22 Oct 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
- ClinicalTrials.gov ID
- NCT06666257
- Acronym / sponsor ID
- GEM / 276728
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Remote Weight & Step Monitoring + CGM | Experimental | Behavioral: Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in PregnancyWomen 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- pregnant women less than 20 weeks of gestation at time of screening
- 18-45 years of age
- BMI of 25 - 40 kg/m-2
- Expecting a singleton pregnancy
- Smartphone and/or reliable internet access
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in PregnancyThe 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 | Behavioural | Remote Weight & Step Monitoring + CGM |
Primary outcome
Feasibility data of the modified EMI: AR-GEM Study - Recruitment and Retention
Time frame: continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months
Maternal recruitment and retention rates (total number of participants recruited and retained)
Feasibility data of the modified EMI: SmartMomsAR - Acceptability
Time frame: continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months
Acceptability scores from online intervention satisfaction questionnaires, 5 point Likert Scale system
Feasibility data of the modified EMI: SmartMomsAR - Protocol Adherence
Time frame: continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months
Adherence to study protocol via process measures. (Percentage of complete data points)
4 secondary outcomes
Incidence of appropriate gestational weight gain per 2009 NASM guidelines.
Time frame: data is derived through study completion, an average of 6 months.
Change in healthful lifestyle behaviors - HEI
Time frame: data is derived through study completion, an average of 6 months.
Change in healthful lifestyle behaviors - Steps (Physical Activity)
Time frame: data is derived through study completion, an average of 6 months.
Change in healthful lifestyle behaviors - Glycemic profile
Time frame: data is derived through study completion, an average of 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa T Jansen, PhD principal investigator
Arkansas Children's Hospital Research Institute; University of Arkansas for Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy in people with Pregnancies at Increased Risk for Excessive Gestational Weight Gain and Ecological Momentary Assessment and Intervention, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa T Jansen, PhD (5013646516, ltjansen@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility data of the modified EMI: AR-GEM Study - Recruitment and Retention (time frame: continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.