Individually Tailored, Adaptive Intervention to Manage Gestational Weight Gain: Protocol for a Randomized Controlled Trial in Women With Overweight and Obesity

Danielle Symons Downs, Jennifer S Savage, Daniel E Rivera, Joshua M Smyth, Barbara J Rolls, Emily E Hohman, Katherine M McNitt, Allen R Kunselman, Christy Stetter, Abigail M Pauley, Krista S Leonard, Penghong Guo

Research output: Contribution to journalArticle

Abstract

BACKGROUND: High gestational weight gain is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in effectively managing pregnancy weight gain, especially among women with overweight and obesity. Well-designed interventions are needed that take an individualized approach and target unique barriers to promote healthy weight gain.

OBJECTIVE: The primary aim of the study is to describe the study protocol for Healthy Mom Zone, an individually tailored, adaptive intervention for managing weight in pregnant women with overweight and obesity.

METHODS: The Healthy Mom Zone Intervention, based on theories of planned behavior and self-regulation and a model of energy balance, includes components (eg, education, self-monitoring, physical activity/healthy eating behaviors) that are adapted over the intervention (ie, increase in intensity) to better regulate weight gain. Decision rules inform when to adapt the intervention. In this randomized controlled trial, women are randomized to the intervention or standard care control group. The intervention is delivered from approximately 8-36 weeks gestation and includes step-ups in dosages (ie, Step-up 1 = education + physical activity + healthy eating active learning [cooking/recipes]; Step-up 2 = Step-up 1 + portion size, physical activity; Step-up 3 = Step-up 1 + 2 + grocery store feedback, physical activity); 5 maximum adaptations. Study measures are obtained at pre- and postintervention as well as daily (eg, weight), weekly (eg, energy intake/expenditure), and monthly (eg, psychological) over the study period. Analyses will include linear mixed-effects models, generalized estimating equations, and dynamical modeling to understand between-group and within-individual effects of the intervention on weight gain.

RESULTS: Recruitment of 31 pregnant women with overweight and obesity has occurred from January 2016 through July 2017. Baseline data have been collected for all participants. To date, 24 participants have completed the intervention and postintervention follow-up assessments, 3 are currently in progress, 1 dropped out, and 3 women had early miscarriages and are no longer active in the study. Of the 24 participants, 13 women have completed the intervention to date, of which 1 (8%, 1/13) received only the baseline intervention, 3 (23%, 3/13) received baseline + step-up 1, 6 (46%, 6/13) received baseline + step-up 1 + step-up 2, and 3 (23%, 3/13) received baseline + step-up 1 + step-up 2 +step-up 3. Data analysis is still ongoing through spring 2018.

CONCLUSIONS: This is one of the first intervention studies to use an individually tailored, adaptive design to manage weight gain in pregnancy. Results from this study will be useful in designing a larger randomized trial to examine efficacy of this intervention and developing strategies for clinical application.

REGISTERED REPORT IDENTIFIER: RR1-10.2196/9220.

Original languageEnglish (US)
Pages (from-to)e150
JournalJMIR research protocols
Volume7
Issue number6
DOIs
StatePublished - Jun 8 2018

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Weight Gain
Randomized Controlled Trials
Obesity
Exercise
Pregnancy
Pregnant Women
Portion Size
Education
Weights and Measures
Problem-Based Learning
Cooking
Feeding Behavior
Spontaneous Abortion
Energy Intake
Energy Metabolism
Public Health
Mothers
Psychology
Control Groups
Healthy Diet

Cite this

@article{bd23a2d3488946cca86732c8d6f356e4,
title = "Individually Tailored, Adaptive Intervention to Manage Gestational Weight Gain: Protocol for a Randomized Controlled Trial in Women With Overweight and Obesity",
abstract = "BACKGROUND: High gestational weight gain is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in effectively managing pregnancy weight gain, especially among women with overweight and obesity. Well-designed interventions are needed that take an individualized approach and target unique barriers to promote healthy weight gain.OBJECTIVE: The primary aim of the study is to describe the study protocol for Healthy Mom Zone, an individually tailored, adaptive intervention for managing weight in pregnant women with overweight and obesity.METHODS: The Healthy Mom Zone Intervention, based on theories of planned behavior and self-regulation and a model of energy balance, includes components (eg, education, self-monitoring, physical activity/healthy eating behaviors) that are adapted over the intervention (ie, increase in intensity) to better regulate weight gain. Decision rules inform when to adapt the intervention. In this randomized controlled trial, women are randomized to the intervention or standard care control group. The intervention is delivered from approximately 8-36 weeks gestation and includes step-ups in dosages (ie, Step-up 1 = education + physical activity + healthy eating active learning [cooking/recipes]; Step-up 2 = Step-up 1 + portion size, physical activity; Step-up 3 = Step-up 1 + 2 + grocery store feedback, physical activity); 5 maximum adaptations. Study measures are obtained at pre- and postintervention as well as daily (eg, weight), weekly (eg, energy intake/expenditure), and monthly (eg, psychological) over the study period. Analyses will include linear mixed-effects models, generalized estimating equations, and dynamical modeling to understand between-group and within-individual effects of the intervention on weight gain.RESULTS: Recruitment of 31 pregnant women with overweight and obesity has occurred from January 2016 through July 2017. Baseline data have been collected for all participants. To date, 24 participants have completed the intervention and postintervention follow-up assessments, 3 are currently in progress, 1 dropped out, and 3 women had early miscarriages and are no longer active in the study. Of the 24 participants, 13 women have completed the intervention to date, of which 1 (8{\%}, 1/13) received only the baseline intervention, 3 (23{\%}, 3/13) received baseline + step-up 1, 6 (46{\%}, 6/13) received baseline + step-up 1 + step-up 2, and 3 (23{\%}, 3/13) received baseline + step-up 1 + step-up 2 +step-up 3. Data analysis is still ongoing through spring 2018.CONCLUSIONS: This is one of the first intervention studies to use an individually tailored, adaptive design to manage weight gain in pregnancy. Results from this study will be useful in designing a larger randomized trial to examine efficacy of this intervention and developing strategies for clinical application.REGISTERED REPORT IDENTIFIER: RR1-10.2196/9220.",
author = "{Symons Downs}, Danielle and Savage, {Jennifer S} and Rivera, {Daniel E} and Smyth, {Joshua M} and Rolls, {Barbara J} and Hohman, {Emily E} and McNitt, {Katherine M} and Kunselman, {Allen R} and Christy Stetter and Pauley, {Abigail M} and Leonard, {Krista S} and Penghong Guo",
note = "{\circledC}Danielle Symons Downs, Jennifer S Savage, Daniel E Rivera, Joshua M Smyth, Barbara J Rolls, Emily E Hohman, Katherine M McNitt, Allen R Kunselman, Christy Stetter, Abigail M Pauley, Krista S Leonard, Penghong Guo. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.06.2018.",
year = "2018",
month = "6",
day = "8",
doi = "10.2196/resprot.9220",
language = "English (US)",
volume = "7",
pages = "e150",
journal = "JMIR research protocols",
issn = "1929-0748",
number = "6",

}

Individually Tailored, Adaptive Intervention to Manage Gestational Weight Gain : Protocol for a Randomized Controlled Trial in Women With Overweight and Obesity. / Symons Downs, Danielle; Savage, Jennifer S; Rivera, Daniel E; Smyth, Joshua M; Rolls, Barbara J; Hohman, Emily E; McNitt, Katherine M; Kunselman, Allen R; Stetter, Christy; Pauley, Abigail M; Leonard, Krista S; Guo, Penghong.

In: JMIR research protocols, Vol. 7, No. 6, 08.06.2018, p. e150.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Individually Tailored, Adaptive Intervention to Manage Gestational Weight Gain

T2 - Protocol for a Randomized Controlled Trial in Women With Overweight and Obesity

AU - Symons Downs, Danielle

AU - Savage, Jennifer S

AU - Rivera, Daniel E

AU - Smyth, Joshua M

AU - Rolls, Barbara J

AU - Hohman, Emily E

AU - McNitt, Katherine M

AU - Kunselman, Allen R

AU - Stetter, Christy

AU - Pauley, Abigail M

AU - Leonard, Krista S

AU - Guo, Penghong

N1 - ©Danielle Symons Downs, Jennifer S Savage, Daniel E Rivera, Joshua M Smyth, Barbara J Rolls, Emily E Hohman, Katherine M McNitt, Allen R Kunselman, Christy Stetter, Abigail M Pauley, Krista S Leonard, Penghong Guo. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.06.2018.

PY - 2018/6/8

Y1 - 2018/6/8

N2 - BACKGROUND: High gestational weight gain is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in effectively managing pregnancy weight gain, especially among women with overweight and obesity. Well-designed interventions are needed that take an individualized approach and target unique barriers to promote healthy weight gain.OBJECTIVE: The primary aim of the study is to describe the study protocol for Healthy Mom Zone, an individually tailored, adaptive intervention for managing weight in pregnant women with overweight and obesity.METHODS: The Healthy Mom Zone Intervention, based on theories of planned behavior and self-regulation and a model of energy balance, includes components (eg, education, self-monitoring, physical activity/healthy eating behaviors) that are adapted over the intervention (ie, increase in intensity) to better regulate weight gain. Decision rules inform when to adapt the intervention. In this randomized controlled trial, women are randomized to the intervention or standard care control group. The intervention is delivered from approximately 8-36 weeks gestation and includes step-ups in dosages (ie, Step-up 1 = education + physical activity + healthy eating active learning [cooking/recipes]; Step-up 2 = Step-up 1 + portion size, physical activity; Step-up 3 = Step-up 1 + 2 + grocery store feedback, physical activity); 5 maximum adaptations. Study measures are obtained at pre- and postintervention as well as daily (eg, weight), weekly (eg, energy intake/expenditure), and monthly (eg, psychological) over the study period. Analyses will include linear mixed-effects models, generalized estimating equations, and dynamical modeling to understand between-group and within-individual effects of the intervention on weight gain.RESULTS: Recruitment of 31 pregnant women with overweight and obesity has occurred from January 2016 through July 2017. Baseline data have been collected for all participants. To date, 24 participants have completed the intervention and postintervention follow-up assessments, 3 are currently in progress, 1 dropped out, and 3 women had early miscarriages and are no longer active in the study. Of the 24 participants, 13 women have completed the intervention to date, of which 1 (8%, 1/13) received only the baseline intervention, 3 (23%, 3/13) received baseline + step-up 1, 6 (46%, 6/13) received baseline + step-up 1 + step-up 2, and 3 (23%, 3/13) received baseline + step-up 1 + step-up 2 +step-up 3. Data analysis is still ongoing through spring 2018.CONCLUSIONS: This is one of the first intervention studies to use an individually tailored, adaptive design to manage weight gain in pregnancy. Results from this study will be useful in designing a larger randomized trial to examine efficacy of this intervention and developing strategies for clinical application.REGISTERED REPORT IDENTIFIER: RR1-10.2196/9220.

AB - BACKGROUND: High gestational weight gain is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in effectively managing pregnancy weight gain, especially among women with overweight and obesity. Well-designed interventions are needed that take an individualized approach and target unique barriers to promote healthy weight gain.OBJECTIVE: The primary aim of the study is to describe the study protocol for Healthy Mom Zone, an individually tailored, adaptive intervention for managing weight in pregnant women with overweight and obesity.METHODS: The Healthy Mom Zone Intervention, based on theories of planned behavior and self-regulation and a model of energy balance, includes components (eg, education, self-monitoring, physical activity/healthy eating behaviors) that are adapted over the intervention (ie, increase in intensity) to better regulate weight gain. Decision rules inform when to adapt the intervention. In this randomized controlled trial, women are randomized to the intervention or standard care control group. The intervention is delivered from approximately 8-36 weeks gestation and includes step-ups in dosages (ie, Step-up 1 = education + physical activity + healthy eating active learning [cooking/recipes]; Step-up 2 = Step-up 1 + portion size, physical activity; Step-up 3 = Step-up 1 + 2 + grocery store feedback, physical activity); 5 maximum adaptations. Study measures are obtained at pre- and postintervention as well as daily (eg, weight), weekly (eg, energy intake/expenditure), and monthly (eg, psychological) over the study period. Analyses will include linear mixed-effects models, generalized estimating equations, and dynamical modeling to understand between-group and within-individual effects of the intervention on weight gain.RESULTS: Recruitment of 31 pregnant women with overweight and obesity has occurred from January 2016 through July 2017. Baseline data have been collected for all participants. To date, 24 participants have completed the intervention and postintervention follow-up assessments, 3 are currently in progress, 1 dropped out, and 3 women had early miscarriages and are no longer active in the study. Of the 24 participants, 13 women have completed the intervention to date, of which 1 (8%, 1/13) received only the baseline intervention, 3 (23%, 3/13) received baseline + step-up 1, 6 (46%, 6/13) received baseline + step-up 1 + step-up 2, and 3 (23%, 3/13) received baseline + step-up 1 + step-up 2 +step-up 3. Data analysis is still ongoing through spring 2018.CONCLUSIONS: This is one of the first intervention studies to use an individually tailored, adaptive design to manage weight gain in pregnancy. Results from this study will be useful in designing a larger randomized trial to examine efficacy of this intervention and developing strategies for clinical application.REGISTERED REPORT IDENTIFIER: RR1-10.2196/9220.

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DO - 10.2196/resprot.9220

M3 - Article

C2 - 29884603

VL - 7

SP - e150

JO - JMIR research protocols

JF - JMIR research protocols

SN - 1929-0748

IS - 6

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