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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03945266
Recruitment Status Completed
First Posted May 10, 2019
Last update posted May 10, 2019
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.
The research proposed here will establish the dosage of components needed to impact GWG and develop an efficient (optimized) intervention to effectively manage GWG in OW/OBPW before a randomized controlled trial (RCT) can be implemented. The aims of the proposed research are: to establish feasibility of delivering an individually-tailored behavioral intervention for managing GWG in OW/OBPW. Two studies will be conducted to establish feasibility. Study 1 will examine viability of delivering dosages/sequencing of components (education, goal-setting, self-monitoring, HE/PA), GWG/HE/PA self-monitoring using e-health technology mechanisms, and data collection by delivering varied dosages to OW/OBPW over a brief, 4-week period followed by focus groups to evaluate user acceptability. The investigators will then make necessary revisions to the intervention. Study 2 will pilot test intervention delivery with decision rules for when/how to adapt dosages for an individual and randomization/retention/data collection procedures with treatment and control groups in a new cohort of OW/OBPW. Also, the investigators aim to use feasibility data collected from Aim 1 and control systems engineering to build a model that characterizes the effects of energy balance and planned/self-regulatory behaviors on GWG over time and use this model to develop an optimized intervention. The investigators will identify a dynamical model from feasibility data collected in Aim 1 that considers how changes in GWG responds to changes in energy intake, PA, and planned/self-regulatory behaviors. Model predictive control (a decision-making method from control systems engineering) will inform how the dosage adaptations are decided. The investigators will then identify a customized intervention plan for each woman based on her levels of energy intake, PA, planned/self-regulatory behaviors and the extent to which she is meeting GWG goals over pregnancy. This will lead to final program modifications and result in an individually-tailored, optimized intervention. The investigators will test the efficacy of this optimized intervention for managing GWG in OW/OBPW in a future RCT. This innovative research will develop an individually-tailored, optimized intervention that effectively and efficiently manages GWG in OW/OBPW and that will eventually be available to all pregnant women (via e-health technology) to improve the health of mothers and infants and impact the etiology of obesity and cardiovascular disease at a critical time in the life cycle.
|Experimental: Intervention group
Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting.
Behavioral: Intervention group
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.
|Active Comparator: Control group
Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal.
Behavioral: Control group
Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Pregnant women
- Overweight or obese [body mass index range 24- >40 (if BMI (kg/m^2) is > 40,
consultation with woman's health care provider (PCP/OBGYN) will be made to determine
eligibility and ensure she does not have any contraindications to exercise) PI
Danielle Downs will have communication with Dr. Hovick from MNPG to give information
on the woman. The investigators also have a physician consent form (see Physician
Patient Consent to Participate in documents) that the physician will complete as to
whether the woman is eligible or not eligible to participate.
- Normal weight women with a BMI range of 18.0 to 23.9 can be enrolled in to the study
as control participants (same measures of data collection, no opportunity for
- Ages 18-40 years [based on pilot data this group comprises >85% of the live births in
- 1st, 2nd or 3rd pregnancy 6-16 weeks gestation
- Able to read, understand, and speak English
- Residing in and around State College, PA
- 1st and 2nd time pregnant mothers [none or one other live or still born, biological
children > 25 weeks gestation prior to this pregnancy; it may be conceivable that a
woman has a blended family due to a mixed marriage and she will not be excluded if she
is a parent to a guardian, foster child, or step child]
- Access to a computer or willingness to come onsite to complete study materials
- Infants born to participants who are 6-10 weeks old
- Having more than one live or stillborn child > 25 weeks gestation; late-term pregnancy
- Diabetes at study entry [while future adaptations of this study will target women with
diabetes, for the pilot study, they will be excluded to control for this confound]
- Contraindications to exercise in pregnancy [Hemodynamically significant heart disease,
Restrictive lung disease, Incompetent cervix/cerclage, Persistent second [or third]
trimester bleeding, Placenta previa after 26 weeks of gestation, Premature labor
during the current pregnancy, Ruptured membranes, Preeclampsia/pregnancy-induced
hypertension] per the ACOG guidelines [ACOG Committee on Obstetric Practice. [(2015,
December). ACOG Committee opinion. Number 650: Physical Activity and Exercise During
Pregnancy and the Postpartum Period. Obstetrics and Gynecology, 126,(6), 135-142].
- Having a body mass index less than 18 or over 40 (exclusion only if physician doesn't
provide consent for BMI is over 40)
- Not planning to live in the area for the study duration
- Severe allergies or dietary restrictions that would preclude eating healthy foods
- Not able to read, understand, and/or speak English
- Cognitively impaired
- Currently smoking
- Infants not born to participants
- Infants younger than 6 weeks old
United States, Pennsylvania
Penn State University
National Heart, Lung, and Blood Institute (NHLBI)
Arizona State University
Principal Investigator: Danielle S Downs, Ph.D. The Pennsylvania State University
Symons Downs D, Savage JS, Rivera DE, Smyth JM, Rolls BJ, Hohman EE, McNitt KM, Kunselman AR, Stetter C, Pauley AM, Leonard KS, Guo P. Individually Tailored, Adaptive Intervention to Manage Gestational Weight Gain: Protocol for a Randomized Controlled Trial in Women With Overweight and Obesity. JMIR Res Protoc. 2018 Jun 8;7(6):e150. doi: 10.2196/resprot.9220.
Guo P, Rivera DE, Pauley AM, Leonard KS, Savage JS, Downs DS. A "Model-on-Demand" Methodology For Energy Intake Estimation to Improve Gestational Weight Control Interventions. Proc IFAC World Congress. 2018;51(15):144-149. doi: 10.1016/j.ifacol.2018.09.105. Epub 2018 Oct 8.
Rauff EL, Downs DS. A Prospective Examination of Physical Activity Predictors in Pregnant Women with Normal Weight and Overweight/Obesity. Womens Health Issues. 2018 Nov - Dec;28(6):502-508. doi: 10.1016/j.whi.2018.09.003. Epub 2018 Oct 15.
Rauff EL, Downs DS. Mobile Health Technology in Prenatal Care: Understanding OBGYN Providers' Beliefs about Using Technology to Manage Gestational Weight Gain. J Technol Behav Sci. 2019 Mar;4(1):17-24. doi: 10.1007/s41347-018-0068-0. Epub 2018 Aug 15.
Savage JS, Hohman EE, McNitt KM, Pauley AM, Leonard KS, Turner T, Pauli JM, Gernand AD, Rivera DE, Symons Downs D. Uncontrolled Eating during Pregnancy Predicts Fetal Growth: The Healthy Mom Zone Trial. Nutrients. 2019 Apr 21;11(4). pii: E899. doi: 10.3390/nu11040899.
Pauley AM, Hohman E, Savage JS, Rivera DE, Guo P, Leonard KS, Symons Downs D. Gestational Weight Gain Intervention Impacts Determinants of Healthy Eating and Exercise in Overweight/Obese Pregnant Women. J Obes. 2018 Oct 1;2018:6469170. doi: 10.1155/2018/6469170. eCollection 2018.
Guo P, Rivera DE, Savage JS, Hohman EE, Pauley AM, Leonard KS, Downs DS. System Identification Approaches For Energy Intake Estimation: Enhancing Interventions For Managing Gestational Weight Gain. IEEE Trans Control Syst Technol. 2020 Jan;28(1):63-78. doi: 10.1109/TCST.2018.2871871. Epub 2018 Oct 12.
Freigoun MT, Rivera DE, Guo P, Hohman EE, Gernand AD, Downs DS, Savage JS. A Dynamical Systems Model of Intrauterine Fetal Growth. Math Comput Model Dyn Syst. 2018;24(6):661-687. doi: 10.1080/13873954.2018.1524387. Epub 2018 Oct 7.
Guo P, Rivera DE, Savage JS, Downs DS. State Estimation Under Correlated Partial Measurement Losses: Implications for Weight Control Interventions. Proc IFAC World Congress. 2017 Jul;50(1):13532-13537. doi: 10.1016/j.ifacol.2017.08.2347. Epub 2017 Oct 18.
Devlin CA, Huberty J, Downs DS. Influences of prior miscarriage and weight status on perinatal psychological well-being, exercise motivation and behavior. Midwifery. 2016 Dec;43:29-36. doi: 10.1016/j.midw.2016.10.010. Epub 2016 Oct 29.
Guo P, Rivera DE, Downs DS, Savage JS. Semi-physical Identification and State Estimation of Energy Intake for Interventions to Manage Gestational Weight Gain. Proc Am Control Conf. 2016 Jul;2016:1271-1276. Epub 2016 Aug 1.
Downs DS, Devlin CA, Rhodes RE. The Power of Believing: Salient Belief Predictors of Exercise Behavior in Normal Weight, Overweight, and Obese Pregnant Women. J Phys Act Health. 2015 Aug;12(8):1168-76. doi: 10.1123/jpah.2014-0262. Epub 2014 Nov 19.
Savage JS, Downs DS, Dong Y, Rivera DE. Control systems engineering for optimizing a prenatal weight gain intervention to regulate infant birth weight. Am J Public Health. 2014 Jul;104(7):1247-54. doi: 10.2105/AJPH.2014.301959. Epub 2014 May 15.
Dong Y, Deshpande S, Rivera DE, Downs DS, Savage JS. Hybrid Model Predictive Control for Sequential Decision Policies in Adaptive Behavioral Interventions. Proc Am Control Conf. 2014 Jun;2014:4198-4203.
Dong Y, Rivera DE, Thomas DM, Navarro-Barrientos JE, Downs DS, Savage JS, Collins LM. A Dynamical Systems Model for Improving Gestational Weight Gain Behavioral Interventions. Proc Am Control Conf. 2012:4059-4064.