Recruiting

Behavioral Lifestyle Intervention

Sponsor:

Arkansas Children's Hospital Research Institute

Code:

NCT06666257

Conditions

Pregnancies at Increased Risk for Excessive Gestational Weight Gain

Ecological Momentary Assessment and Intervention

Continuous Glucose Monitor

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06666257

Start date

Mar 1, 2025

Status verified date

May, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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 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 .

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 6 months following screening.

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Remote Weight & Step Monitoring + CGM

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.

Interventions

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

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

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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Lisa T Jansen, PhD

5013646516ltjansen@uams.edu

Sharon E Sanders, PhD, MPH, CHES

501-364-5118SESanders@uams.edu

Locations

Arkansas Children's Research Institute - Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Elizabeth Hayes, Recruitment Coordinator

501-364-3309ACNCStudies@uams.edu

Principal Investigator:

Lisa T Jansen, PhD

More Information

Sponsor

Arkansas Children's Hospital Research Institute

Last update posted

Oct 9, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.