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Helping Moms to be Healthy After Baby

Primary Purpose

Weight Loss, Diet Modification, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Observation Group participants
Lifestyle group participants
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Weight Loss

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Aurora WIC Office
  • University of Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Observational Group

Lifestyle Group

Arm Description

Intervention: 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.

Intervention: 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.

Outcomes

Primary Outcome Measures

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
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.
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
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.
Evaluation of the Use of Phone Coaching
Investigators will count the total number of times any participant used phone coaching.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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
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.
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.

Full Information

First Posted
August 1, 2017
Last Updated
March 6, 2020
Sponsor
University of Colorado, Denver
Collaborators
Colorado Clinical & Translational Sciences Institute, National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT03257657
Brief Title
Helping Moms to be Healthy After Baby
Official Title
Helping Moms to be Healthy After Baby
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
February 22, 2018 (Actual)
Study Completion Date
February 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Colorado Clinical & Translational Sciences Institute, National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Diet Modification, Obesity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Observational Group
Arm Type
Experimental
Arm Description
Intervention: 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.
Arm Title
Lifestyle Group
Arm Type
Experimental
Arm Description
Intervention: 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.
Intervention Type
Behavioral
Intervention Name(s)
Observation Group participants
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle group participants
Intervention Description
Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Primary Outcome Measure Information:
Title
Feasibility of Recruitment
Description
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
Time Frame
Once the final participant is recruited
Title
Attrition Rate of Subjects Enrolled in the Study
Description
The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.
Time Frame
Once the final participant completes the 12 week visit
Title
Visit Attendance
Description
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
Time Frame
Baseline through Week 12, reported at Week 12
Title
Acceptability of a Weight Loss Intervention
Description
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.
Time Frame
12 weeks
Title
Evaluation of the Use of Phone Coaching
Description
Investigators will count the total number of times any participant used phone coaching.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Weight Between Visits
Description
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.
Time Frame
Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks
Title
Changes in Diet: Intakes Measured in Grams
Description
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.
Time Frame
Baseline and 12 weeks
Title
Changes in Physical Activity
Description
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.
Time Frame
Baseline and 12 weeks
Title
Changes in Diet and Physical Activity Self-efficacy
Description
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.
Time Frame
Baseline and 12 weeks
Title
Changes in Motivations to Eat
Description
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.
Time Frame
Baseline and 12 weeks
Title
Changes in Readiness to Change
Description
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
Time Frame
Baseline and 12 weeks
Title
Changes in Diet: Intakes Measured in Cups
Description
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.
Time Frame
Baseline and 12 weeks
Title
Changes in Diet: kCal Intake
Description
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.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darcy A Thompson, MD, MPH
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aurora WIC Office
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80011
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Helping Moms to be Healthy After Baby

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