NCT02168647

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

2.4 years

First QC Date

June 18, 2014

Last Update Submit

March 17, 2018

Conditions

Excessive Weight Gain in Pregnancy With Baby Delivered

Keywords

Excessive gestational weight gainInsulin resistancePhysical activityBehavioral prenatal lifestyle interventionReduced carbohydrate intakeSelf-determination theoryMotivational interviewing

Outcome Measures

Primary Outcomes (1)

  • Maternal Body Weight Change

    Gestational weight gain as measured by last pre-delivery weight minus self-reported pre-pregnancy weight. Maternal weight will be measured at each routine prenatal appointment and plotted on the IOM pregnancy weight gain chart. Body composition changes measured by BodPod at baseline and 2 months postpartum.

    From 14 weeks of gestation through 2 months post partum

Secondary Outcomes (3)

  • Maternal Postpartum Depression and Perceived Quality of Life

    Baseline through 2 months post partum

  • Maternal Insulin Resistance

    Maternal 26th-28th week of gestation

  • Postpartum Weight Retention

    From 14 weeks of gestation through 2 months post partum

Other Outcomes (1)

  • Infant Outcomes

    2 months post partum

Study Arms (2)

Behavioral Lifestyle counseling

EXPERIMENTAL

Intervention group participants will take part in behavioral lifestyle counseling provided by a Registered Dietitian Nutritionist from week 14 of gestation through childbirth.

Behavioral: Behavioral Lifestyle counseling

Control

ACTIVE COMPARATOR

Participants in the control arm will receive no form of lifestyle intervention.

Other: Control

Interventions

Behavioral Lifestyle counselingBEHAVIORAL

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.

Behavioral Lifestyle counseling
ControlOTHER

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.

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women between the ages of 18-45 with a pre-pregnancy BMI between 18.5-35.0 kg/m2 will be recruited for this study.
  • Qualified pregnant women include those participating in a low-active or sedentary lifestyle defined as \<3 30-minute exercise sessions per week and therefore, are not currently meeting physical activity guidelines during pregnancy.
  • Participants will need to have qualification criteria confirmed by their medical provider prior to beginning the first data collection period.

You may not qualify if:

  • Pregnant beyond 14 weeks gestation
  • Multiple fetuses
  • History of smoking during pregnancy
  • History of gestational diabetes mellitus, pre-eclampsia, or chronic disease (e.g. Type 1 diabetes, Type 2 diabetes, heart disease, renal disease, or untreated thyroid conditions)
  • Inability to comprehend the information shared during the informed consent process
  • Any adverse reactions to armband monitors (e.g. metal allergies, electromagnetic devices)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iowa State University

Ames, Iowa, 50011, United States

Location

Related Publications (1)

  • Buckingham-Schutt LM, Ellingson LD, Vazou S, Campbell CG. The Behavioral Wellness in Pregnancy study: a randomized controlled trial of a multi-component intervention to promote appropriate weight gain. Am J Clin Nutr. 2019 Apr 1;109(4):1071-1079. doi: 10.1093/ajcn/nqy359.

    PMID: 30949691DERIVED

MeSH Terms

Conditions

Insulin ResistanceMotor Activity

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Officials

  • Christina Campbell, Ph.D.

    Iowa State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Christina Campbell, Associate Professor

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 20, 2014

Study Start

March 1, 2015

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

March 20, 2018

Record last verified: 2018-03

Locations

US(1)