Clinical trial NCT03257657: Helping Moms to be Healthy After Baby
Official title: Helping Moms to be Healthy After Baby
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Diet Modification
Obesity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado Clinical & Translational Sciences Institute
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2017-08-22
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot, randomized controlled trial. The investigators will pilot a multi-component intervention delivered in a WIC (Women, Infants, children) setting.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Feasibility of Recruitment
timeFrame: Once the final participant is recruited
measure: Attrition Rate of Subjects Enrolled in the Study
timeFrame: Once the final participant completes the 12 week visit
measure: Visit Attendance
timeFrame: Baseline through Week 12, reported at Week 12
measure: Acceptability of a Weight Loss Intervention
timeFrame: 12 weeks
measure: Evaluation of the Use of Phone Coaching
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Weight Between Visits
timeFrame: Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks
measure: Changes in Diet: Intakes Measured in Grams
timeFrame: Baseline and 12 weeks
measure: Changes in Physical Activity
timeFrame: Baseline and 12 weeks
measure: Changes in Diet and Physical Activity Self-efficacy
timeFrame: Baseline and 12 weeks
measure: Changes in Motivations to Eat
timeFrame: Baseline and 12 weeks
measure: Changes in Readiness to Change
timeFrame: Baseline and 12 weeks
measure: Changes in Diet: Intakes Measured in Cups
timeFrame: Baseline and 12 weeks
measure: Changes in Diet: kCal Intake
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Aurora WIC Office
state: Colorado
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Darcy A Thompson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: