Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0

Not Applicable

Recruiting

• Conditions: Gestational Weight Gain; Overweight and Obesity; Pregnancy; Energy Balance

• Registration Number: NCT05807594
• Lead Sponsor: Penn State University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-3-6
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 144

Inclusion Criteria

Inclusion Criteria:<br><br> - Pregnant women<br><br> - = 8 and < 18 weeks gestation at time of screening. This range of gestational age is<br> chosen to: a) reduce chances of false pregnancy or miscarriage under 8 weeks<br> gestation and b) recruit women in the 1st trimester for greatest impact of the<br> intervention on gestational weight gain. In the feasibility and initial impact<br> study, the investigators had less than 10% (n=3) miscarriages prior to randomization<br> using these criteria<br><br> - Singleton gestation<br><br> - Any parity (i.e., first-time pregnancy, second pregnancy, etc.)<br><br> - Any race/ethnicity<br><br> - Ages 18-45 years [based on our pilot data this group comprises more than 85% of the<br> live births in Central Pennsylvania]<br><br> - Overweight or obese: body mass index (BMI) range 24.0 to 45.0. If BMI is over 40,<br> consultation with woman's health care provider will be made to determine eligibility<br> and ensure she does not have any contraindications to physical activity or other<br> concerns with intervention participation.<br><br> - Haven't exceeded 25% or more of their total GWG (based on BMI and IOM guidelines)<br> from pre-pregnancy to date of enrollment.<br><br> - Participant has physician consent to confirm subject participation<br><br> - Able to read, understand, and speak English<br><br> - Residing in the United States<br><br> - Access to a computer/phone<br><br> - Willingness and ability to complete study materials and intervention sessions<br> electronically (e.g., email, Facetime, Zoom), at home (e.g., Zoom sessions delivered<br> synchronous and asynchronous) or if requested by the participant, on-site at Penn<br> State University Park or Hershey campuses.<br><br> - Not currently smoking<br><br> - No severe allergies/dietary restrictions/eating disorders that may preclude study<br> participation<br><br> - No diagnosed insomnia<br><br> - No absolute contraindications to exercise in pregnancy and relative<br> contraindications with provider consent (see below)<br><br>Exclusion Criteria:<br><br> - Not pregnant women<br><br> - Men (unable to become pregnant)<br><br> - Multiple gestation<br><br> - < 8 weeks gestation or > 18 weeks gestation at time of pre-intervention assessment<br><br> - Outside of the age range of 18-45 years<br><br> - Outside of the BMI range of 24.0-45.0<br><br> - Exceeded 25% of their total GWG (based on BMI and IOM guidelines) from pre-pregnancy<br> to date of enrollment<br><br> - Not able to read and/or understand English<br><br> - Not residing in the United States<br><br> - Unable to access materials by computer or phone (even with data plan assistance if<br> necessary)<br><br> - Currently smoking<br><br> - Pre-existing diabetes<br><br> - Diagnosed insomnia (women will self-report their insomnia)<br><br> - Pre-existing eating disorders. Women will self-report their eating disorder<br> diagnosis history and the study team will check their electronic health record<br> data/confirm with physician.<br><br> - Severe allergies and dietary restrictions that may preclude study participation.<br><br> - Contraindications to aerobic exercise in pregnancy:<br><br>Absolute:<br><br>Haemodynamically significant heart disease Restrictive lung disease Incompetent<br>cervix/cerclage Multiple gestation at risk for premature labor Persistent second or third<br>trimester bleeding Placenta praevia after 26 weeks gestation Premature labor during the<br>current pregnancy Ruptured membranes Pregnancy induced hypertension<br><br>Relative (if permission is not given by provider):<br><br>Severe anemia Unevaluated maternal cardiac arrhythmia Chronic bronchitis Poorly<br>controlled type I diabetes Extreme morbid obesity Extreme underweight (body mass index<br>less than 12.0) History of extremely sedentary lifestyle Intrauterine growth restriction<br>in current pregnancy Poorly controlled hypertension/pre-eclampsia Orthopedic limitations<br>Poorly controlled seizure disorder Poorly controlled thyroid disease Heavy smoker

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gestational Weight Gain and Weight Change;Physical Activity (PA) and Sedentary Behavior;Energy Intake (EI) Estimation (Back-Calculation of Energy Intake)