Healthy Mom Zone: A Gestational Weight Gain Management Intervention

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

Interventions

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.

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Arizona State University

  collaborator OTHER

• Penn State University

  lead OTHER

Principal Investigators

• Danielle S Downs, Ph.D. · The Pennsylvania State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-07-08

Primary Completion

2018-01-11

Completion

2018-03-30

Countries

• United States

Study Locations