Skip to main content
OpenTrials
Completed

NCT Number: NCT03257657

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Weight Loss Body Weight Body Weight Changes Diet Modification Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aurora WIC Office, Aurora, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observation Group participants

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 participants

Behavioral

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

Primary outcomes

  1. Feasibility of Recruitment

    Time frame: Once the final participant is recruited

    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

  2. Attrition Rate of Subjects Enrolled in the Study

    Time frame: Once the final participant completes the 12 week visit

    The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.

  3. Visit Attendance

    Time frame: Baseline through Week 12, reported at Week 12

    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

  4. Acceptability of a Weight Loss Intervention

    Time frame: 12 weeks

    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.

  5. Evaluation of the Use of Phone Coaching

    Time frame: 12 weeks

    Investigators will count the total number of times any participant used phone coaching.

Secondary outcomes

  1. Change in Weight Between Visits

    Time frame: Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks

    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.

  2. Changes in Diet: Intakes Measured in Grams

    Time frame: Baseline and 12 weeks

    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.

  3. Changes in Physical Activity

    Time frame: Baseline and 12 weeks

    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.

  4. Changes in Diet and Physical Activity Self-efficacy

    Time frame: Baseline and 12 weeks

    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.

  5. Changes in Motivations to Eat

    Time frame: Baseline and 12 weeks

    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.

  6. Changes in Readiness to Change

    Time frame: Baseline and 12 weeks

    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

  7. Changes in Diet: Intakes Measured in Cups

    Time frame: Baseline and 12 weeks

    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.

  8. Changes in Diet: kCal Intake

    Time frame: Baseline and 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Colorado Clinical & Translational Sciences Institute
  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2017
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.