Postpartum Weight Retention

Study Overview
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Brief Summary
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The Postpartum Weight Management Study is a true community-academic collaboration, bringing together Maternity Care Coalition (MCC) staff and the investigator, Dr. Charmaine Smith Wright from the University of Pennsylvania to address the needs of postpartum moms. The project is an innovative intervention to help moms lose weight after the birth of their baby. Helping mothers control their weight during pregnancy and beyond can help both mother and baby avoid later obesity and cardiovascular disease. Although all women are at risk for retaining the weight gained during pregnancy, this problem is amplified for low-income, minority women. The holistic approach aims to prevent postpartum weight retention and increase breastfeeding duration with a multi-component, low-cost intervention that provides: 1) Motivational appeals delivered in text message format; 2) Environmental aides, such as a baby carrier to combine exercise with infant care, and a pedometer to accurately measure exercise at home; 3) Enhanced peer support, including home visits and group classes with other mothers; and 4) Task-oriented professional support from nutrition and lactation experts, who assist women in developing a personalized health plan. The effectiveness of the intervention will be evaluated using a randomized control methodology among clients of MCC.

Official Title
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A Randomized Controlled Trial (RCT) of an Intervention to Combat Postpartum Weight Retention

Conditions
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Obesity, Hypertension, Depression

Intervention / Treatment
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* Behavioral: 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All women who speak English, and are within six weeks of delivering a live, term, single infants Exclusion Criteria: Women who have multiple births or preterm (<38 weeks gestation) infants
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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Enhanced control<br>Regular care as provided by the community based organization from which the convenience sample is recruited with one year of assessments only | |
| Experimental: Intervention<br>6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes | Behavioral: 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes<br>* 6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum weight change | Weight difference at one year post intervention and start of intervention | Baseline and 1 year post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum weight change | Weight difference at 6 months post intervention and start of intervention | Baseline and 6 months post intervention start | 
| Depression | Using Edinburgh perinatal depression screen score, as a continuous and dichotomous (Yes/No) variable | Baseline, 6 weeks, 6 months, and 1 year post intervention start | 
| Dietary quality | Descriptive analysis of a food log from the time points proposed | Baseline, 6 weeks, 6 months, and 1 year post intervention | 
| Infant growth | Infant weight for length percentile at 6 weeks, 6 months, and 1 year post intervention (weight in pounds and length in inches converted to weight for length percentile using World Health Organization software support http://www.who.int/childgrowth/software/readme_stata.pdf?ua=1) | Baseline, 6 weeks, 6 months, and 1 year post intervention start | 
| Nutrition knowledge score change | Using validated nutrition knowledge scale at 6 weeks, 6 months, and 1 year post intervention, difference from baseline | Baseline, 6 weeks, 6 months, and 1 year post intervention start | 
| Waist circumference as continuous measure, in inches | Acquired at study assessments at the proposed time points | Baseline, 6 weeks, 6 months, and 1 year post intervention start | 
| Back to prepregnancy weight | Dichotomous (yes/no) variable describing whether the subject returned to pre-pregnancy weight (difference between 1 year post and self-reported pre-pregnancy weight at baseline time point survey=0) or not | baseline and 1 year post intervention | 
| Back to pregnancy weight, continuous | Continuous (difference in 1 year post-intervention weight and self-reported pre-pregnancy weight reported at baseline time point survey) variable describing the change in weight over time | baseline and 1 year postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervention study, Maternal obesity, Nutrition, Maternal child health