Healthy Mom Zone: A Gestational Weight Gain Management Intervention
Palabras clave
Abstracto
Descripción
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.
fechas
Verificado por última vez: | 04/30/2019 |
Primero enviado: | 05/05/2019 |
Inscripción estimada enviada: | 05/06/2019 |
Publicado por primera vez: | 05/09/2019 |
Última actualización enviada: | 05/06/2019 |
Última actualización publicada: | 05/09/2019 |
Fecha de inicio real del estudio: | 07/07/2014 |
Fecha estimada de finalización primaria: | 01/10/2018 |
Fecha estimada de finalización del estudio: | 03/29/2018 |
Condición o enfermedad
Intervención / tratamiento
Behavioral: Intervention group
Behavioral: Control group
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
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. |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | Female |
Acepta voluntarios saludables | si |
Criterios | 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 |
Salir
Medidas de resultado primarias
1. Gestational Weight Change [Baseline, through study completion (ever day for ~6 months). Weight will also be measured for a week at 6 weeks postpartum]
Medidas de resultado secundarias
1. Theory of Planned Behavior (Motivational Determinants of Healthy Eating) [Baseline, through study completion (each week and each month for ~6 months), 6 weeks postpartum]
2. Theory of Planned Behavior (Motivational Determinants of Physical Activity) [Baseline, through study completion (each week and each month for ~6 months), 6 weeks postpartum]
3. Self-regulation of Healthy Eating [Baseline, through study completion (every other week for ~6 months), 6 weeks postpartum]
4. Self-regulation of Physical Activity [Baseline, through study completion (every other week for ~6 months), 6 weeks postpartum]
5. Tangney Self-Control Scale [Baseline, through study completion (every month for ~6 months), 6 weeks postpartum]
6. MyFitnessPal [Baseline, through study completion (every day for ~6 months), 6 weeks postpartum]
7. Leisure Time Exercise Questionnaire [Baseline, through study completion (every month for ~6 months), 6 weeks postpartum]
8. Self-report physical activity log [Baseline, through study completion (every other week for ~6 months), 6 weeks postpartum]
9. Objective activity monitor Actigraph wGt3X-BTl [Baseline, through study completion (every day, for 3 week, ever 2 weeks for ~6 months), 6 weeks postpartum]
10. Objective activity monitor UP Jawbone [Baseline, through study completion (every day for ~6 months), 6 weeks postpartum]
11. Three Factor Eating Questionnaire [Baseline, through study completion (every month for ~6 months), 6 weeks postpartum]
12. Remote Food Photography [Three days a week at study's end (~35 weeks gestation) and three days a week at 6 weeks postpartum]
13. Pittsburgh Sleep Quality Index [Baseline, through study completion (every month for ~6 months), 6 weeks postpartum]
14. Sleep Behaviors (activity monitor) [Baseline, through study completion (every day for ~6 months), 6 weeks postpartum]
15. Adult Temperament (Rothbart Adult Temperament) [Baseline]
16. Socio-demographic and health correlates [Baseline]
17. Fetal measure: ultrasounds [fetal growth] [Through study completion (every month for ~6 months), 6 weeks postpartum]
18. Infant birthweight [6 weeks postpartum]
19. Infant length [6 weeks postpartum]
20. Resting Metabolic Rate [Baseline, through study completion (every week for ~6 months), 6 weeks postpartum]
21. Body Area Satisfaction Scale [Baseline, through study completion (every month for ~6 months), 6 weeks postpartum]
22. Center for Epidemiological Studies Depression Scale [Baseline, through study completion (every month for ~6 months)]
23. Pregnancy Figure Rating Scale [Baseline, through study completion (every day for ~6 months)]
24. State-Trait Anxiety Inventory [Baseline, through study completion (every month for ~6 months), 6 weeks postpartum]
25. Perceived Stress Scale [Baseline, through study completion (every week for ~6 months), 6 weeks postpartum]