Clinical trial NCT06666257: Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Official title: Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2024-10-30
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the feasibility of adding Continuous Glucose Monitoring (CGM) as a self-monitoring tool to an existing Ecological Momentary Intervention (EMI) in pregnant women with obesity but without diabetes.

In Phase I (Formative Stage) Participants will engage in Focus Groups or interviews and provide feedback on the existing SmartMoms intervention as well as the researcher's plans to integrate CGM.

In Phase II, Participants will be randomized to either SmartMoms or SmartMoms+CGM during weeks 12-40 of pregnancy. Through participant feedback, compliance and gestational weight gain outcome data feasibility and acceptability scores will be derived.

Detailed description: The purpose of this study is to assess feasibility of adapting an established gestational weight gain intervention approach to the specific needs of women in Arkansas. A formative phase will inform appropriate adjustments to existing intervention features as well as the support requested for wearing a continuous glucose monitor and reviewing its data. Like the original intervention, the newly adapted intervention will encourage participants to meet the updated exercise guidelines for pregnancy which recommends 30 min or more of moderate exercise a day on most if not all days of the week, and to eat a balanced diet within a caloric intake range conducive to appropriate gestational weight gain. Participants will be required to provide a daily bodyweight and step count which will be transmitted automatically with daily use of the provided devices (internet connected bodyweight scale, and pedometer). Participants in the intervention group will also wear a CGM sensor throughout pregnancy to track temporal glucose profiles. SmartMoms (trademarked) is an evidence based behavioral intervention designed to encourage appropriate gestational weight gain in women with overweight and obesity. Women will receive daily prompts and feedback on their current weight gain trajectory. Prompts will include educational sessions on healthy eating and exercising during pregnancy and will be delivered electronically to participant's smartphones and email. Participants will interact with RD health coaches and review their activity and dietary choices. The intervention group will also review their glycemic patterns in response to these choices with the study RDs. To provide participant support, the investigators will establish a closed online forum/group for community support and exchange, following the SmartMoms framework. Women will be in either SmartMoms or SmartMoms +CGM for 28 weeks, from week 12 - 40 of pregnancy. All SmartMoms counseling sessions will be conducted by a trained research staff member, and the participants will be trained on a one-to-one basis on how to engage with SmartMoms and the CGM component safely.

Eligibility criteria: The formative phase (Phase I), classified as exempt by the institutional review board will seek participation from individuals meeting the following criteria:

1. Currently pregnant or pregnant within the past 36 months.
2. Community partners with relevant perspectives to inform recruitment, adaptation approaches and feasibility of the phase 2 pilot trial.

Clinical Trial (Phase 2)

Inclusion Criteria:

* pregnant women less than 14 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 .

Exclusion Criteria:

* 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 10 months following screening.

Primary outcomes:
measure: Feasibility data of the modified EMI: SmartMomsAR - Recruitment and Retention
timeFrame: continuous, from study enrollment at 12-16 weeks until study completion, an average of 10 months
measure: Feasibility data of the modified EMI: SmartMomsAR - Acceptability
timeFrame: continuous, from study enrollment at 12-16 weeks until study completion, an average of 10 months
measure: Feasibility data of the modified EMI: SmartMomsAR - Protocol Adherence
timeFrame: continuous, from study enrollment at 12-16 weeks until study completion, an average of 10 months
Secondary outcomes:
measure: Incidence of appropriate gestational weight gain per 2009 NASM guidelines.
timeFrame: data is derived through study completion, an average of 10 months.
measure: Change in healthful lifestyle behaviors - HEI
timeFrame: data is derived through study completion, an average of 10 months.
measure: Change in healthful lifestyle behaviors - Steps (Physical Activity)
timeFrame: data is derived through study completion, an average of 10 months.
measure: Change in healthful lifestyle behaviors - Glycemic profile
timeFrame: data is derived through study completion, an average of 10 months.
Other outcomes:
Locations:
Study officials:
affiliation: Arkansas Children's Hospital Research Institute; University of Arkansas for Medical Sciences
name: Lisa T Jansen, PhD
role: PRINCIPAL_INVESTIGATOR
References: