Helping Moms to be Healthy After Baby

University of Colorado, Denver42 enrolled

Overview

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.

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. Obesity science supports that weight loss interventions should be multi-component with regular points of contact. Building upon this, we have designed a multi-component intervention that considers the demands on women in the postpartum period and utilizes technology for both provider decision support and for virtual contact with participants. The intervention will address diet, physical activity, and social support through the use of in-person meetings with WIC staff, text messaging, phone coaching, self-monitoring, and Facebook.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Interventions

Observation Group participantsBEHAVIORAL

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.

Lifestyle group participantsBEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adult woman (≥18 and \<50 years old). * Enrolled in WIC or with an infant enrolled in WIC. * 3-12 months postpartum. * A pre-pregnancy BMI of 25 - 40 kg/m2 (based on self-reported height and weight prior to pregnancy). * Postpartum body mass index between 25 and 50 kg/m2. * English- and/or Spanish-speaking. * Owns a mobile phone with texting functionality in order to receive texts during the trial. Exclusion Criteria: * Health conditions impacting weight or ability to participate in a weight loss trial. * Pregnancy or planned pregnancy in next 5 months. * Any health problems or undergoing any treatments that might interfere with what participant eats or her ability to exercise. * Medical provider recommendation to avoid exercise. * Plans to be in a different geographic area within the next 5 months. * Plans to stop coming to Aurora WIC in the next 5 months. * Unable to give informed consent. * Not able to read and understand English or Spanish at an 8th grade level. * Not willing to create a Facebook account if they do not already have one. * Asked to follow-up in \< 3 months at most recent WIC visit.

Outcomes

Primary Outcomes

Feasibility of Recruitment

The investigators plan to determine the feasibility of recruitment for a weight loss intervention by evaluating the rate of recruitment. Below describes number recruited/enrolled over 14 weeks of recruitment

Time frame: Once the final participant is recruited

Attrition Rate of Subjects Enrolled in the Study

The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.

Time frame: Once the final participant completes the 12 week visit

Visit Attendance

The investigators will measure lifestyle group participant attendance from enrollment through the 12-week visit. The number of participants who attended their visits is reported

Time frame: Baseline through Week 12, reported at Week 12

Acceptability of a Weight Loss Intervention

To determine acceptability, investigators will use qualitative interviews to ask open-ended questions on this topic including asking participants in the intervention whether they would participate again. The number of participants interviewed who indicated that they would participate again is reported.

Time frame: 12 weeks

Evaluation of the Use of Phone Coaching

Investigators will count the total number of times any participant used phone coaching.

Time frame: 12 weeks

Secondary Outcomes

Change in Weight Between Visits

To determine differences in change in weight between the intervention and control groups, participants will be weighed on a scale in the Women, Infants, and Children (WIC) setting.

Time frame: Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks

Changes in Diet: Intakes Measured in Grams

To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.