Helping Moms to be Healthy After Baby
NCT03257657 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2020-03-20
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
- Weight Loss
- Diet Modification
- Obesity
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
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