Helping Moms to be Healthy After Baby

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; Diet Modification
• Intervention / Treatment: Behavioral: Observation Group participants; Behavioral: Lifestyle group participants

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Aurora, Colorado, United States, 80011
      • Aurora WIC Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	Behavioral: Lifestyle group participants; Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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.	12 weeks
Evaluation of the Use of Phone Coaching	Investigators will count the total number of times any participant used phone coaching.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline and 12 weeks
Changes in Physical Activity	To determine differences in total physical activity from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of the Pregnancy Physical Activity Questionnaire. This is a validated survey measure for physical activity.	Baseline and 12 weeks
Changes in Diet and Physical Activity Self-efficacy	To determine differences in self-efficacy from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of Eating Habits Confidence Survey and Exercise Confidence Survey. Diet self-efficacy: Possible range: -32 to 32; Higher scores indicate improved self-efficacy. Physical activity self-efficacy: Sticking to it scale: Possible range: -32 to 32; Higher scores indicate improved self-efficacy. Making time scale: -12 to 12; Higher scores indicate improved self-efficacy.	Baseline and 12 weeks
Changes in Motivations to Eat	To determine differences from baseline to12 weeks in motivations to eat between intervention and control groups, participants will complete the Eating Stimulus Index questionnaire. Possible range = -92 to 92. Higher scores indicated improved lifestyle-related behaviors and motivations to eat.	Baseline and 12 weeks
Changes in Readiness to Change	Investigators will evaluate any differences in readiness to change from baseline to 12 weeks between intervention and control groups by participants completing the Readiness to Change questionnaire. Possible range = -3 to 3; higher scores indicate greater change in readiness to change	Baseline and 12 weeks
Changes in Diet: Intakes Measured in Cups	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. Fruit and vegetable intake changes are measured and reported in cups.	Baseline and 12 weeks
Changes in Diet: kCal Intake	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.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Center for Advancing Translational Sciences (NCATS); Colorado Clinical & Translational Sciences Institute
• Investigators: Principal Investigator: Darcy A Thompson, MD, MPH, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Actual): February 22, 2018
• Study Completion (Actual): February 22, 2018

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 16-1932; UL1TR002535 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No