Helping Moms to be Healthy After Baby

Obesity Clinical Trial

Official title:

Helping Moms to be Healthy After Baby

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257657
• Other study ID #: 16-1932
• Secondary ID: UL1TR002535
• Status: Completed
• Phase: N/A
• Start date: July 31, 2017
• Est. completion date: February 22, 2018

Study information

• Verified date: March 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 22, 2018
• Est. primary completion date: February 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet Modification
• Obesity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Aurora WIC Office	Aurora	Colorado
United States	University of Colorado	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Colorado Clinical & Translational Sciences Institute, National Center for Advancing Translational Science (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Evaluation of the Use of Phone Coaching	Investigators will count the total number of times any participant used phone coaching.	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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