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, 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

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.

Keywords: adaptive intervention; body weight maintenance; exercise; gestational weight gain; intervention study; mHealth; nutrition science; obesity; overweight; pregnant women; randomized controlled trial.

Conflict of interest statement

Conflicts of Interest: None declared.

©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.

Figures

Figure 1
Figure 1
Flow of participants through Healthy Mom Zone Intervention (still underway) as per Consolidated Standards for Reporting Trials guidelines. Participants allocated to intervention group could be assigned to various step-ups throughout the intervention time period. Step-ups will vary by individual and time-point of intervention and gestation. Incomplete cells are due to ongoing data collection.
Figure 2
Figure 2
Conceptual framework for Healthy Mom Zone Intervention. HE: healthy eating; PA: physical activity, GWG: gestational weight gain.
Figure 3
Figure 3
Energy balance model underlying the Healthy Mom Zone Intervention. TPB: Theory of Planned Behavior; I1…In: Intervention components; i: exogenous variables that serve as inputs for behavioral models; yi: system outputs; ξ1: Behavioral belief × evaluation of outcome; ξ2: Normative belief × motivation to comply; ξ3: Control belief × power of control belief; I1: Healthy Eating Education; I2: Healthy Eating Weekly Plan; I3: Healthy Eating Active Learning; I4: Goal Setting; I5: Physical Activity Education; I6: Physical Activity Weekly Plan; I7: Physical Activity Session; I8: Daily Weight Scale; I9: Dietary Record; I10: PA monitor output. Black solid line shows input/output signals between models; Black dashed line shows self-regulation feedback loop; Blue dashed line shows intervention dosages which indicate how and when the intervention is adapted; Green dashed line shows tailoring variables that inform whether the intervention is adapted; Circle dashed line shows regular measurement of important outcomes (self-regulation intervention).
Figure 4
Figure 4
Healthy Mom Zone Intervention components. Components in light blue are in baseline intervention and delivered throughout the duration of the intervention. Active Learning component is adapted depending on decision rules and gestational weight gain (GWG) evaluations. BMI: body mass index.
Figure 5
Figure 5
Preliminary visualization of a Healthy Mom Zone Intervention participant’s gestational weight gain data. The intervention participant’s measured weight is plotted against her predicted weight (based on the computerized applet) and the Institute of Medicine upper and lower ranges for recommended weight gain for a woman who is OW. Her EI (measured with phone app and estimated with a back-calculation formula) and PA (measured with wrist-worn activity monitor) are also plotted. BMI: body mass index; OW: overweight; INT: intervention participant; W: weight; EI: energy intake; PA: physical activity; kcal: kilocalories.

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