The Blossom Project: "Be-Well" Behavioral Wellness Study in Pregnancy

Summary

Multiple studies have demonstrated a very low prevalence of women meeting physical activity and weight gain recommendations during pregnancy. The aim of this study is to provide a lifestyle intervention to increase physical activity, reduce carbohydrate intake, prevent excessive gestational weight gain, decrease postpartum weight retention, and improve mental well-being compared to "usual care" using a randomized controlled design in pregnant women. Participants in the intervention group will receive behavioral lifestyle counseling and take part in monthly one-on-one visits with a registered dietitian (RDN) from approximately week 14 of their pregnancy to child birth. Participants in the "usual care" group (control) will not receive any lifestyle counseling. Data collected from this group will be used to compare the effectiveness of the lifestyle intervention. Unlike many studies examining diet and physical activity factors alone, this study evaluates additional psychosocial factors such as psychological health, self-efficacy, competence, motivation and barriers that may influence excessive gestational weight gain. In addition, the Self-Determination Theory framework will be used to measure how motivation and motivational interviewing strategies can help explain changes in volitional behavior.

Conditions

• Excessive Weight Gain in Pregnancy With Baby Delivered

Interventions

BEHAVIORAL

Behavioral Lifestyle counseling

Participants in the intervention group will take part in one-on-one visits with a registered dietitian nutritionist (RDN) from no later than week 14 to child birth at the OBGYN clinic where the participant receives her routine prenatal care or the Nutrition Wellness Research Center in the Iowa State Research Park. These visits will be coordinated with her routine prenatal appointment; therefore a minimum of 6 face-to-face meetings will occur. The counseling sessions will focus on appropriate weight gain during pregnancy through the use of an individualized meal plan, physical activity goals, and behavioral modification. Weight gain will be plotted on an IOM weight gain chart and discussed with study RDN.

OTHER

Control

Participants in the control arm will receive no form of lifestyle intervention. Women will be provided with usual care by their physician. Participants in the control arm will have their weight gain plotted on an IOM growth chart and sent electronically by research staff after each routine prenatal appointment. No other feedback on weight gain or behavior modification will be provided by the study RDN.

Sponsors & Collaborators

• Iowa State University

  lead OTHER

Principal Investigators

• Christina Campbell, Ph.D. · Iowa State University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2017-08-31

Completion

2017-10-31

Countries

• United States

Study Locations