Helping Moms to be Healthy After Baby

Study Overview
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Brief Summary
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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
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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.

Official Title
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Helping Moms to be Healthy After Baby

Conditions
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Weight Loss, Diet Modification, Obesity

Intervention / Treatment
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* Behavioral: Observation Group participants
* Behavioral: Lifestyle group participants


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Observational Group<br>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. | Behavioral: Observation Group participants<br>* 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.<br>|
| Experimental: Lifestyle Group<br>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. | Behavioral: Lifestyle group participants<br>* Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Evaluation of the Use of Phone Coaching | Investigators will count the total number of times any participant used phone coaching. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |