Helping Moms to be Healthy After Baby

NCT ID: NCT03257657

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2018-02-22

Brief 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.

Detailed Description

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.

Conditions

Weight Loss; Diet Modification; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Observational Group

Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.

Group Type: EXPERIMENTAL

Observation Group participants

Intervention Type: BEHAVIORAL

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

Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.

In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.

Group Type: EXPERIMENTAL

Lifestyle group participants

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Lifestyle group participants

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Colorado Clinical & Translational Sciences Institute

OTHER

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darcy A Thompson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Aurora WIC Office

Aurora, Colorado, United States

University of Colorado

Aurora, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UL1TR002535

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-1932

Identifier Type: -

Identifier Source: org_study_id