N/A
N=42
Helping Moms to be Healthy After Baby
Weight Loss · Diet Modification · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03257657 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Feasibility of Recruitment — 22; 19 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Observation Group participants (Behavioral); Lifestyle group participants (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Recruitment |
22; 19 | — |
| PRIMARY Attrition Rate of Subjects Enrolled in the Study |
0; 4 | — |
| PRIMARY Visit Attendance |
7; 5; 3; 3 | — |
| PRIMARY Acceptability of a Weight Loss Intervention |
14 | — |
| PRIMARY Evaluation of the Use of Phone Coaching |
1 | — |
| SECONDARY Change in Weight Between Visits |
-0.8; -4.7 | 0.1 |
| SECONDARY Changes in Diet: Intakes Measured in Grams |
-3.7; -4.1; 0.2; -1.2; -35.1; -25.2 | — |
| SECONDARY Changes in Physical Activity |
-45.5; 38.6 | 0.13 |
| SECONDARY Changes in Diet and Physical Activity Self-efficacy |
-0.5; 0.4; -0.3; 0.0; 3.3; -0.1 | — |
| SECONDARY Changes in Motivations to Eat |
-3.3; 5.9 | 0.02 sig |
| SECONDARY Changes in Readiness to Change |
0; 1.0; 0; 1.0; 0; 1.0 | — |
| SECONDARY Changes in Diet: Intakes Measured in Cups |
-0.2; 0; -0.1; 0.3 | — |
| SECONDARY Changes in Diet: kCal Intake |
-294; -297 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03257657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.