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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Healthy Mom Zone: A Gestational Weight Gain Management Intervention

Clinicaltrials.gov identifier NCT03945266

Recruitment Status Completed

First Posted May 10, 2019

Last update posted May 10, 2019

Study Description

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.

  • Condition or Disease:Overweight and Obesity
    Physical Activity
    Weight Change, Body
    Eating Behavior
  • Intervention/Treatment: Behavioral: Intervention group
    Behavioral: Control group
  • Phase: N/A
Detailed Description

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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 31 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Participants are randomly assigned to an intervention or control group
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Control Systems Engineering for Optimizing a Prenatal Weight Gain Intervention
  • Actual Study Start Date: July 2014
  • Actual Primary Completion Date: January 2018
  • Actual Study Completion Date: March 2018
Arms and interventions
Arm Intervention/treatment
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.
Outcome Measures
  • Primary Outcome Measures: 1. Gestational Weight Change [ Time Frame: Baseline, through study completion (ever day for ~6 months). Weight will also be measured for a week at 6 weeks postpartum ]
    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.
  • Secondary Outcome Measures: 1. Theory of Planned Behavior (Motivational Determinants of Healthy Eating) [ Time Frame: Baseline, through study completion (each week and each month for ~6 months), 6 weeks postpartum ]
    The Theory of Planned Behavior will inform our dynamical model in order to create individualized interventions for OW/OBPW. Beliefs: These items were developed from the work of Blanchard et al. (2009a; 2009b), Murnaghan et al. (2010) and the research team to assess Theory of Planned Behavior (TPB) behavioral, control, and normative beliefs. Main Constructs: The Theory of Planned Behavior (TPB) Healthy Eating Main Constructs measure is a 38-item measure developed from the work of Blanchard et al. (2009a; 2009b), Murnaghan et al. (2010), as well as from the recommendations of Azjen (1991) and the research team to assess the main constructs of the TPB (i.e., attitude, subjective norm, perceived behavioral control, intention) as they relate to healthy eating behavior. Higher total scores (summed) of main constructs indicate higher levels of those main constructs.
  • 2. Theory of Planned Behavior (Motivational Determinants of Physical Activity) [ Time Frame: Baseline, through study completion (each week and each month for ~6 months), 6 weeks postpartum ]
    The Theory of Planned Behavior will inform our dynamical model in order to create individualized interventions for OW/OBPW. Beliefs: These items were developed from the work of Blanchard et al. (2009a; 2009b), Murnaghan et al. (2010) and the research team to assess Theory of Planned Behavior (TPB) behavioral, control, and normative beliefs. Main Constructs: The Theory of Planned Behavior (TPB) Physical Activity Main Constructs measure is a 38-item measure developed from the work of Blanchard et al. (2009a; 2009b), Murnaghan et al. (2010), as well as from the recommendations of Azjen (1991) and the research team to assess the main constructs of the TPB (i.e., attitude, subjective norm, perceived behavioral control, intention) as they relate to physical activity behavior. Higher total scores (summed) of main constructs indicate higher levels of those main constructs.
  • 3. Self-regulation of Healthy Eating [ Time Frame: Baseline, through study completion (every other week for ~6 months), 6 weeks postpartum ]
    Self-regulation of HE will be measured in order to inform our dynamical model and to how well OW/OBPW are at regulating their energy intake and expenditure and how it impacts their GWG. These items were taken from Ryan Rhodes items for self-regulation of PA and adapted for HE behaviors. Ryan has indicated that these items work really well as an index for HE self-regulation because these behaviors are naturally inter-connected but to look at specific self-regulatory behaviors: Item #1: self-monitoring Item #2: goal-setting Item # 3: action planning Item #4: coping planning Item #5: scheduling Item #6, 7, 8, and 9 - #6 was developed by Ryan, 7, 8, and 9 the investigators developed Items 10 &11: affective There are also 2 sets of 8 questions-first 8 examine prospective behaviors while the second set assesses retrospective behaviors. Total scores range from 22-110. A higher score indicates higher levels of HE self-regulation.
  • 4. Self-regulation of Physical Activity [ Time Frame: Baseline, through study completion (every other week for ~6 months), 6 weeks postpartum ]
    Self-regulation of PA will be measured in order to inform our dynamical model and to how well OW/OBPW are at regulating their energy intake and expenditure and how it impacts their GWG. These items are taken from Ryan Rhodes. Ryan has indicated that these items work really well as an index because these behaviors are naturally inter-connected but to look at specific self-regulatory behaviors: Item #1: self-monitoring Item #2: goal-setting Item # 3: action planning Item #4: coping planning Item #5: scheduling Item #6, 7, 8, 9: cuing - #6 was developed by Ryan, 7, 8, and 9 the investigators developed Items 10 & 11: affective There are also 2 sets of 8 questions-first 8 examine prospective behaviors while the second set assesses retrospective behaviors. Total scores range from 22-110. A higher score indicates higher levels of PA self-regulation.
  • 5. Tangney Self-Control Scale [ Time Frame: Baseline, through study completion (every month for ~6 months), 6 weeks postpartum ]
    The Tangney Self Control Scale is a 13-item scale, developed by Tangney et al. (2004), designed to measure the degree of self-control participants have in their lives. Tangney and colleagues began by generating a larger pool of 93 items that encompassed all the spheres of self-control failure covered in an extensive review they conducted on published studies on self-control processes and failures (i.e., control over thoughts, emotional control, impulse control, performance regulation, and habit breaking). Items were rated on a 5-point scale, anchored from 1 "not at all like me" to 5 "very much like me." Scores range from 13-65. Higher scores indicate higher self-control.
  • 6. MyFitnessPal [ Time Frame: Baseline, through study completion (every day for ~6 months), 6 weeks postpartum ]
    MyFitness Pal: Web-based and smartphone app dietary intake tracker.
  • 7. Leisure Time Exercise Questionnaire [ Time Frame: Baseline, through study completion (every month for ~6 months), 6 weeks postpartum ]
    The Leisure-Time Exercise Questionnaire (LTEQ) is a 3 item questionnaire developed by Godin and Shephard (1985) to measure the amount and intensity of exercise a person engages in during a one week period.A total metabolic equivalent (MET) score is generated by multiplying the intensity level by the estimated rate of energy expenditure [total LTEQ = (9 x strenuous) + (5 x moderate) + (3 x mild)]. Previous research using this measure has modified the quantification of exercise to include average minutes rather than metabolic equivalents across a week to better examine whether or not participants were meeting exercise guidelines (Courneya et al., 2004; Courneya, et al., 2007). Thus, outcomes can be quantified in MET equivalents or by multiplying reported values of strenuous, moderate, and mild physical activity (PA) by 15 to get total min/week for each type and then adding those values together to total min of weekly exercise.
  • 8. Self-report physical activity log [ Time Frame: Baseline, through study completion (every other week for ~6 months), 6 weeks postpartum ]
    Physical Activity (PA) Log: A daily log asking a series of questions: 'if they were physically active that day'- if yes 'what activities they did', if it was a normal day in terms of their physical activity and if no, an 'explanation of why'.
  • 9. Objective activity monitor Actigraph wGt3X-BTl [ Time Frame: Baseline, through study completion (every day, for 3 week, ever 2 weeks for ~6 months), 6 weeks postpartum ]
    Women will be wearing the Actigraph monitor for 7 days during their free living immediately following their baseline appointment and again for 7 days immediately following their final appointment. Women will also be wearing the Actigraph for 3 weeks during the intervention phase of the study - the Actigraph is being counterbalanced with the UP Jawbone where half of the women will wear the Actigraph for the first two weeks of the intervention phase and the other half for the last two weeks of the intervention phase.
  • 10. Objective activity monitor UP Jawbone [ Time Frame: Baseline, through study completion (every day for ~6 months), 6 weeks postpartum ]
    Women will be wearing the UP Jawbone for the entire six week intervention. UP will track how the participants sleep, move and eat so the women will be able to make smarter choices. Women will be wearing the UP Jawbone in counterbalance with the Actigraph wGt3X-BTI.
  • 11. Three Factor Eating Questionnaire [ Time Frame: Baseline, through study completion (every month for ~6 months), 6 weeks postpartum ]
    The Three Factor Eating Questionnaire is a 51-item questionnaire developed by Stunkard and Messick (1985) to measure three dimensions of human eating behavior: 1) dietary restraint, or cognitive control of eating behavior, 2) dietary disinhibition, or disinhibition of cognitive control of eating, and 3) susceptibility to hunger. The investigators are only using 18 items of the revised TFEQ from Cappelleri (2009). These items are known as TFEQ-R18 as reported in (de Lauzon et al., 2004). The TFEQ is examined by subscale scores and not by a total score. Subscale scores for the cognitive restraint scale range from 6-24; higher scores indicate higher levels of cognitive restraint of eating. Uncontrolled eating scale range from 9-36; higher scores indicate higher levels of uncontrolled eating behaviors. Emotional eating scale range from 3-12; higher scores indicate higher levels of emotional eating behaviors.
  • 12. Remote Food Photography [ Time Frame: Three days a week at study's end (~35 weeks gestation) and three days a week at 6 weeks postpartum ]
    Remote Food Photography Method: Participants capture photos of all food and beverages consumed both prior to consuming the meal or snack and of the leftover food or beverage that was not consumed.
  • 13. Pittsburgh Sleep Quality Index [ Time Frame: Baseline, through study completion (every month for ~6 months), 6 weeks postpartum ]
    Pittsburgh Sleep Quality Index: The Pittsburgh Sleep Quality Index (PSQI) is an 18-item measure developed by Smyth (2003) to measure the quality and patterns of sleep in older adults. It differentiates "poor" from "good" sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction over the last month. The participant self-rates each of these seven areas of sleep. Scoring of answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. An overall sleep quality score greater than or equal to 5 reflects poor sleep quality.
  • 14. Sleep Behaviors (activity monitor) [ Time Frame: Baseline, through study completion (every day for ~6 months), 6 weeks postpartum ]
    UP Jawbone activity monitor: women wear the monitor during the night and day. The monitor measures sleep duration, number of awakenings, nap duration, etc.
  • 15. Adult Temperament (Rothbart Adult Temperament) [ Time Frame: Baseline ]
    The Adult Temperament Questionnaire (ATQ) is a 19 item questionnaire adapted from the Physiological Reactions Questionnaire developed by Derryberry and Rothbart (1988) that assesses the constructs associated with adult temperament. Based upon recent studies (Rothbart, Ahadi, & Evans, 2000) the investigators have formulated a self-report model of temperament including general constructs of effortful control and negative affect. The investigators are using the Effortful Control (factors: Attentional Control, Inhibitory Control, Activation Control) and Negative Affect Subscales (factors: Fear, Sadness, Discomfort, and Frustration: Negative affect related to interruption of ongoing tasks or goal blocking.) Total score ranges from 19-133 and the factor scales are averaged.
  • 16. Socio-demographic and health correlates [ Time Frame: Baseline ]
    Participants will be completing measures assessing general demographic information, their health history and family health history as well as their pregnancy history and complications in any previous pregnancies that did go to full term.
  • 17. Fetal measure: ultrasounds [fetal growth] [ Time Frame: Through study completion (every month for ~6 months), 6 weeks postpartum ]
    Ultrasounds are conducted each month to measure fetal growth.
  • 18. Infant birthweight [ Time Frame: 6 weeks postpartum ]
    The infant's birth weight will be obtained through medical records or self-report from mother
  • 19. Infant length [ Time Frame: 6 weeks postpartum ]
    The infant's birth length will be obtained through medical records or self-report from mother
  • 20. Resting Metabolic Rate [ Time Frame: Baseline, through study completion (every week for ~6 months), 6 weeks postpartum ]
    The Breezing Device: An indirect calorimetry analyzer that measures the rate of oxygen consumption and carbon dioxide production and determines how much energy the body is burning due to the metabolism of nutrients (named Resting Energy Expenditure, REE), and the type of nutrients the body uses to produce energy (Energy source = respiratory quotient, RQ). Developed at Arizona State University. The Breezing is a cellphone-size, battery operated, portable technology that syncs with smartphones. This tracker takes a traditional laboratory-based measurement and makes it faster, more affordable and mobile. Breezing has a 99.8% correlation with the gold standard method, Douglas Bag (Forzani, Tao, et.al., Clinical Nutrition, 2013).
  • 21. Body Area Satisfaction Scale [ Time Frame: Baseline, through study completion (every month for ~6 months), 6 weeks postpartum ]
    The Body Area Satisfaction Scale (BASS) measure is a 9-item subscale originating from the Multidimensional Body-Self Relations Questionnaire (MBSRQ), which is a 69-item self-report inventory for the assessment of self-attitudinal aspects of the construct of body-image. Developed by Cash (1990), the BASS assesses one's personal satisfaction with body parts such as arms, legs, and face in which participants rate their degree of body satisfaction with each specified body party from 1 (very dissatisfied) to 5 (very satisfied). The first 8 of the 9 items are added together for a total score.Scores range from 8-40. A higher score indicates higher body satisfaction
  • 22. Center for Epidemiological Studies Depression Scale [ Time Frame: Baseline, through study completion (every month for ~6 months) ]
    Center for Epidemiological Studies Depression Scale (CESD): Measures current levels of depressive symptomology. A cut off score of 16 is used to determine case status (depressed versus not depressed). A total CES-D score can be calculated [Total CES-D Score = sum (items 1-20)]. Scores range from 0-60
  • 23. Pregnancy Figure Rating Scale [ Time Frame: Baseline, through study completion (every day for ~6 months) ]
    The Body Figures Rating Scale is a 3-item scale that was developed by Stunkard, Sorenson and Schulsinger (1983), to assess body dissatisfaction. The scale consists of a set of nine male and female figures that range from underweight to overweight. Subjects are asked to rate the nine figures based on their current body size and their ideal body size which has been adapted to pregnancy figures. Subjects are asked to rate the figures based on the following instructional protocol: (a) current size (i.e. "which figure looks the most like you") and (b) ideal size (i.e. "which figure would you like to look like"). The difference between the ratings is a discrepancy index and is considered to represent the individual's level of dissatisfaction. For analyzing purposes, satisfaction scores can be grouped categorically where 1 = satisfied, 2 = wants to be thinner, and 3 = wants to be fatter.
  • 24. State-Trait Anxiety Inventory [ Time Frame: Baseline, through study completion (every month for ~6 months), 6 weeks postpartum ]
    The State-Trait Anxiety Inventory (STAI) is a 20-item questionnaire developed by Spielberger (1983), to measure state and trait anxiety. The State version of the STAI is being used for the current study. This scale consists of twenty items that evaluate how respondents feel "right now, at this moment." In responding to the STAI State-Anxiety scale, participants choose the response statement that best describes the intensity of their feelings: (1) not at all; (2) somewhat; (3) moderately so; (4) very much so. The state version of the STAI can also be used to evaluate how someone felt at a particular time in the recent past and how they anticipated to feel either in a specific situation that is likely to be encountered in the future or in a variety of hypothetical situations. A total score is used to determine anxiety with a higher score indicating higher anxiety.
  • 25. Perceived Stress Scale [ Time Frame: Baseline, through study completion (every week for ~6 months), 6 weeks postpartum ]
    The Perceived Stress Scale (PSS) is a 10-item scale developed by Cohen (1988) that measures the degree to which situations in one's life are appraised as stressful. The PSS was designed for use with community samples with at least a junior high-school education. The 14 items are easy to understand and the response alternatives (never, almost never, neutral, sometimes, fairly often, very often) are simple to grasp. The questions are quite general in nature and hence relatively free of content specific to any sub-population group. Scores range from 0-40. A higher score indicates higher levels of perceived stress.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 40 Years (Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- 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]

- 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

Exclusion Criteria:

- 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].

- 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

Contacts and Locations
Contacts
Locations

United States, Pennsylvania
Noll Laboratory
University Park

Sponsors and Collaborators

Penn State University

National Heart, Lung, and Blood Institute (NHLBI)

Arizona State University

Investigators

Principal Investigator: Danielle S Downs, Ph.D. The Pennsylvania State University

More Information