Helping Moms to be Healthy After Baby
2 other identifiers
interventional
42
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2017
CompletedFirst Submitted
Initial submission to the registry
August 1, 2017
CompletedFirst Posted
Study publicly available on registry
August 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2018
CompletedResults Posted
Study results publicly available
March 20, 2020
CompletedMarch 20, 2020
March 1, 2020
7 months
August 1, 2017
May 31, 2019
March 6, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
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The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.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 Outcomes (8)
Change in Weight Between Visits
Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks
Changes in Diet: Intakes Measured in Grams
Baseline and 12 weeks
Changes in Physical Activity
Baseline and 12 weeks
Changes in Diet and Physical Activity Self-efficacy
Baseline and 12 weeks
Changes in Motivations to Eat
Baseline and 12 weeks
- +3 more secondary outcomes
Study Arms (2)
Observational Group
EXPERIMENTALIntervention: 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.
Lifestyle Group
EXPERIMENTALIntervention: 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.
Interventions
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.
Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Eligibility Criteria
You may qualify if:
- Adult woman (≥18 and \<50 years old).
- Enrolled in WIC or with an infant enrolled in WIC.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aurora WIC Office
Aurora, Colorado, 80011, United States
University of Colorado
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Darcy Thompson, Associate Professor
- Organization
- University of Colorado
Study Officials
- PRINCIPAL INVESTIGATOR
Darcy A Thompson, MD, MPH
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2017
First Posted
August 22, 2017
Study Start
July 31, 2017
Primary Completion
February 22, 2018
Study Completion
February 22, 2018
Last Updated
March 20, 2020
Results First Posted
March 20, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share