Helping Moms to be Healthy After Baby

NCT03257657 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-03-20

Study results available
· View outcomes & findings →

Summary

Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women. Aims for this pilot study are listed below:

Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss intervention delivered in a WIC setting to a population of low-income, predominantly racial/ethnic minority, obese, postpartum women.

Aim 2: To evaluate differences in weight change, diet, physical activity, self-efficacy, readiness to change, motivations to eat between intervention and control participants to determine preliminary intervention efficacy over a 12-week period.

Conditions

Interventions

BEHAVIORAL

Observation Group participants

Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.

BEHAVIORAL

Lifestyle group participants

Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.

Sponsors & Collaborators

  • Colorado Clinical & Translational Sciences Institute

    collaborator OTHER
  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH
  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Darcy A Thompson, MD, MPH · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2018-02-22
Completion
2018-02-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03257657 on ClinicalTrials.gov