Healthy Mom Zone: A Gestational Weight Gain Management Intervention

NCT03945266 | Completed Results DMC

• 2 other identifiers: 000037525R01HL119245-05
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and Obesity; Physical Activity; Weight Change, Body; Eating Behavior

Keywords

gestational weight gain; pregnancy weight regulation; individually tailored intervention

Outcome Measures

Primary Outcomes (1)

• Gestational Weight Change

  Gestational weight change will be measured daily at home using the FitBit Aria Wi-Fi Smart Scale (www.fitbit.com; weights will be wirelessly uploaded to online program). Gestational weight change will be standardized: target weight gain will be determined for each woman based on BMI (kg/m\^2) status (OW = 15-25 lb, OB = 11-20 lb). For the criterion measure to determine when to adapt the intervention, weight gain will be calculated to determine if a woman is gaining \< her goal (-), at the exact amount of her goal (0), or \> her goal (+). Pre-pregnancy weight and gestational weight change from the first prenatal visit to the last pre-delivery weight will also be obtained from clinical records. Overweight/obese pregnant women (OW/OBPW) often exceed the GWG guidelines, managing weight gain in this population is critical. Participants weigh themselves daily using a WiFi connected scale. Outcome measure reported at mean change from pre- to post-intervention.

  Daily data was collected starting at baseline (pre-intervention), through study completion Month 6 (post-intervention). Also measured daily for one week at 6-weeks postpartum. Outcome measure reported at mean change from pre- to post-intervention.

Secondary Outcomes (20)

• Theory of Planned Behavior (Motivational Determinants of Healthy Eating)

  Data was collected each month starting at baseline (pre-intervention), through study completion at Month 6 (post-intervention). Pre-intervention, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, post-intervention.

• Theory of Planned Behavior (Motivational Determinants of Physical Activity)

  Data was collected each month starting at baseline (pre-intervention), through study completion at post-intervention - Pre-intervention, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, post-intervention.

• Self-regulation of Healthy Eating

  Data was collected bi-weekly starting at baseline (pre-intervention), through study completion at Month 6 (post-intervention). Pre-intervention week, week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and post-intervention week.

• Self-regulation of Physical Activity

  Data was collected bi-weekly starting at baseline (pre-intervention), through study completion at Month 6 (post-intervention). Pre-intervention week, week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and post-intervention week.

• Objective Activity Monitor UP Jawbone

  Daily data was collected starting at pre-intervention, through study completion post-intervention. Daily for a total of 6 months. Outcome measure reported at mean change from pre- to post-intervention.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal.

Behavioral: Control group

Interventions

Intervention group BEHAVIORAL

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.

Intervention group

Control group BEHAVIORAL

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

Also known as: Prenatal care as usual

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 intervention).
• Ages 18-40 years \[based on pilot data this group comprises \>85% of the live births in Central Pennsylvania\]
• st, 2nd or 3rd pregnancy 6-16 weeks gestation
• Able to read, understand, and speak English
• Residing in and around State College, PA
• st 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

You may not qualify if:

• Having more than one live or stillborn child \> 25 weeks gestation; late-term pregnancy loss
• 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. \[(2015, December). ACOG Committee opinion. Number 650: Physical Activity and Exercise During Pregnancy and the Postpartum Period. Obstetrics and Gynecology, 126,(6), 135-142\].
• 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

Sponsors & Collaborators

• Penn State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Arizona State University: collaborator

Study Sites (1)

Noll Laboratory

University Park, Pennsylvania, 16802, United States

Location

Related Publications (27)

• 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.

  PMID: 29884603 BACKGROUND

• 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. IFAC Pap OnLine. 2018;51(15):144-149. doi: 10.1016/j.ifacol.2018.09.105. Epub 2018 Oct 8.

  PMID: 30480263 BACKGROUND

• 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.

  PMID: 30337214 BACKGROUND

• 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.

  PMID: 30906851 BACKGROUND

• 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.

  PMID: 30364005 BACKGROUND

• 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.

  PMID: 31903018 BACKGROUND

• 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.

  PMID: 30498392 BACKGROUND

• Guo P, Rivera DE, Savage JS, Downs DS. State Estimation Under Correlated Partial Measurement Losses: Implications for Weight Control Interventions. IFAC Pap OnLine. 2017 Jul;50(1):13532-13537. doi: 10.1016/j.ifacol.2017.08.2347. Epub 2017 Oct 18.

  PMID: 29242854 BACKGROUND

• Downs DS. Obesity in Special Populations: Pregnancy. Prim Care. 2016 Mar;43(1):109-20, ix. doi: 10.1016/j.pop.2015.09.003. Epub 2016 Jan 12.

  PMID: 26896204 BACKGROUND

• 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.

  PMID: 27838526 BACKGROUND

• 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. doi: 10.1109/ACC.2016.7525092. Epub 2016 Aug 1.

  PMID: 27570366 BACKGROUND

• 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.

  PMID: 25409425 BACKGROUND

• 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.

  PMID: 24832411 BACKGROUND

• 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. doi: 10.1109/ACC.2014.6859462.

  PMID: 25635157 BACKGROUND

• Downs DS, Savage JS, Rauff EL. Falling Short of Guidelines? Nutrition and Weight Gain Knowledge in Pregnancy. J Womens Health Care. 2014;3:1000184. doi: 10.4172/2167-0420.1000184.

  PMID: 25599012 BACKGROUND

• Dong Y, Rivera DE, Downs DS, Savage JS, Thomas DM, Collins LM. Hybrid Model Predictive Control for Optimizing Gestational Weight Gain Behavioral Interventions. Proc Am Control Conf. 2013:1970-1975. doi: 10.1109/acc.2013.6580124.

  PMID: 24336314 BACKGROUND

• 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. doi: 10.1109/acc.2012.6315424.

  PMID: 24309837 BACKGROUND

• McNitt KM, Hohman EE, Rivera DE, Guo P, Pauley AM, Gernand AD, Symons Downs D, Savage JS. Underreporting of Energy Intake Increases over Pregnancy: An Intensive Longitudinal Study of Women with Overweight and Obesity. Nutrients. 2022 Jun 1;14(11):2326. doi: 10.3390/nu14112326.

  PMID: 35684126 BACKGROUND

• Rosinger AY, Bethancourt HJ, Pauley AM, Latona C, John J, Kelyman A, Leonard KS, Hohman EE, McNitt K, Gernand AD, Downs DS, Savage JS. Variation in urine osmolality throughout pregnancy: a longitudinal, randomized-control trial among women with overweight and obesity. Eur J Nutr. 2022 Feb;61(1):127-140. doi: 10.1007/s00394-021-02616-x. Epub 2021 Jul 3.

  PMID: 34218315 BACKGROUND

• Guo P, Rivera DE, Dong Y, Deshpande S, Savage JS, Hohman EE, Pauley AM, Leonard KS, Downs DS. Optimizing Behavioral Interventions to Regulate Gestational Weight Gain With Sequential Decision Policies Using Hybrid Model Predictive Control. Comput Chem Eng. 2022 Apr;160:107721. doi: 10.1016/j.compchemeng.2022.107721. Epub 2022 Feb 8.

  PMID: 35342207 BACKGROUND

• Leonard KS, Pauley AM, Hohman EE, Guo P, Rivera DE, Savage JS, Buman MP, Symons Downs D. Identifying ActiGraph non-wear time in pregnant women with overweight or obesity. J Sci Med Sport. 2020 Dec;23(12):1197-1201. doi: 10.1016/j.jsams.2020.08.003. Epub 2020 Aug 11.

  PMID: 32859522 BACKGROUND

• Ranghetti L, Rivera DE, Guo P, Visioli A, Savage JS, Symons Downs D. A control-based observer approach for estimating energy intake during pregnancy. Int J Robust Nonlinear Control. 2023 Jun;33(9):5105-5127. doi: 10.1002/rnc.6019. Epub 2022 Jan 30.

  PMID: 37193543 BACKGROUND

• 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):899. doi: 10.3390/nu11040899.

  PMID: 31010102 RESULT

• Downs DS, Savage JS, Rivera DE, Pauley AM, Leonard KS, Hohman EE, Guo P, McNitt KM, Stetter C, Kunselman A. Adaptive, behavioral intervention impact on weight gain, physical activity, energy intake, and motivational determinants: results of a feasibility trial in pregnant women with overweight/obesity. J Behav Med. 2021 Oct;44(5):605-621. doi: 10.1007/s10865-021-00227-9. Epub 2021 May 5.

  PMID: 33954853 RESULT

• Leonard KS, Symons Downs D. Low prenatal resting energy expenditure and high energy intake predict high gestational weight gain in pregnant women with overweight/obesity. Obes Res Clin Pract. 2022 Jul-Aug;16(4):281-287. doi: 10.1016/j.orcp.2022.07.003. Epub 2022 Jul 13.

  PMID: 35840506 RESULT

• Pauley AM, Hohman EE, Leonard KS, Guo P, McNitt KM, Rivera DE, Savage JS, Downs DS. Short Nighttime Sleep Duration and High Number of Nighttime Awakenings Explain Increases in Gestational Weight Gain and Decreases in Physical Activity but Not Energy Intake among Pregnant Women with Overweight/Obesity. Clocks Sleep. 2020 Nov 14;2(4):487-501. doi: 10.3390/clockssleep2040036.

  PMID: 33202691 RESULT

• Hohman EE, Smyth JM, McNitt KM, Pauley AM, Symons Downs D, Savage JS. Urinary cortisol is lower in pregnant women with higher pre-pregnancy BMI. Front Endocrinol (Lausanne). 2023 Jan 11;13:1014574. doi: 10.3389/fendo.2022.1014574. eCollection 2022.

  PMID: 36714602 DERIVED

Related Links

• Youtube video describing the intervention

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity; Body Weight Changes; Feeding Behavior; Gestational Weight Gain

Interventions

Control Groups; Prenatal Care

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Behavior, Animal; Weight Gain

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

We were not adequately powered to detect significant effects on secondary outcomes due to the feasibility study design. Our sample was largely homogenous (Caucasian, middle income, well educated).

Results Point of Contact

• Title: Dr. Abigail Pauley
• Organization: Pennsylvania State University

amp34@psu.edu

814-863-7354

Study Officials

• Danielle S Downs, Ph.D.

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Kinesiology and Obstetrics & Gyneocology

Model Details: Participants are randomly assigned to an intervention or control group

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 10, 2019
• Study Start: July 8, 2014
• Primary Completion: January 11, 2018
• Study Completion: March 30, 2018
• Last Updated: May 24, 2023
• Results First Posted: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)