CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Intervention group +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03945266
NCT03945266N/ACompleted

Control Systems Engineering for Optimizing a Prenatal Weight Gain Intervention

Penn State University·interventional·Posted May 10, 2019·Updated May 24, 2023

In Brief

A clinical study evaluating Intervention group and Control group for Overweight and Obesity and 3 related conditions. Completed, enrolled 31 participants across 1 site.

Detailed Summary

The purpose is to establish feasibility of delivering an individually-tailored, behavioral intervention to manage gestational weight gain \[GWG\] that adapts to the unique needs and challenges of overweight/obese pregnant women \[OW/OBPW\] and will utilize control systems engineering to optimize this intervention; in other words, make this intervention manage GWG in OW/OBPW as effectively and efficiently as possible.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 10, 2019
Enrollment StartJul 8, 2014
Primary CompletionJan 11, 2018
Study CompletionMar 30, 2018
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.1 years ago

Interventions

Intervention groupbehavioral

During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.

Control groupbehavioral

Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.