Postpartum Weight Retention
Conditions
Keywords
pregnancy, weight loss
Brief summary
The purpose of this study is to help women lose the weight they gained during their pregnancy using a SmartPhone app the investigators have developed called E-Moms. The investigators hypothesize that the moms given the app to use during the study will lose more weight than the moms who do not use the app.
Detailed description
The E-Moms Study will last about 4 months. The weight management program is 4 months long and will end about 6 months after the participant's baby is born. All participants will receive Women, Infants and Children (WIC) services. For the weight management program, participants will be put into one of these groups: 1. WIC Moms: receive advice and services for nutrition and weight management after pregnancy from their WIC clinic. 2. WIC E-Moms: receive a personalized diet and exercise plan to help them lose the weight they gained during their pregnancy. All information will be given to them using a SmartPhone, such as an iPhone. They will also get advice and services from your WIC clinic.
Interventions
BEHAVIORALWIC E-Moms
Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week.
Sponsors
University of California, Los Angeles
United States Department of Agriculture (USDA)
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Are a female who has delivered a baby within the last 2 months * Are 18 years of age or older * Have a body mass index ≥25 kg/m2 or \<40 kg/m2 * Are accepted for post-pregnancy WIC services * Are English-speaking
Exclusion criteria
* Are participating in the Nurse Family Partnership program * Had multiples in your most recent pregnancy * Are unwilling to be assigned at random to either of the 2 study groups * Are planning to move out of the study area within the next 6 months * Have a history of psychiatric conditions or chronic disease than can impact body weight, appetite, or energy intake such as HIV/AIDS, cancer, bipolar disorder or schizophrenia * Currently use antipsychotic medications or have used such medications in the previous 12 months * Have been diagnosis with type I diabetes * Report having a heart attack, stroke, or being hospitalized or treated for chest pain * Currently taking medications or supplements to aid in weight loss * Have had weight loss surgery in the past year or plan to have it prior to study completion. * Currently participating in another interventional study that influences weight control * Currently abusing drugs or alcohol (up to 14 drinks per week allowed)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight Change | Baseline and 16 weeks | The primary outcome measure is weight change after the 16 week intervention. |
Countries
United States
Participant flow
Recruitment details
Potential participants will be recruited via Institutional Review Board (IRB) approved posters and flyers displayed in the WIC office and advertisements posted on the PBRC website (http://www.pbrc.edu/clinicaltrials).
Participants by arm
| Arm | Count |
|---|---|
| WIC E-Moms Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week. | 19 |
| WIC Moms Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team. | 16 |
| Total | 35 |
Baseline characteristics
| Characteristic | Total | WIC Moms | WIC E-Moms |
|---|---|---|---|
| Age, Continuous | 26.5 years STANDARD_DEVIATION 5.4 | 27.2 years STANDARD_DEVIATION 6.1 | 26.0 years STANDARD_DEVIATION 5.2 |
| BMI | 32.1 kg/m^2 STANDARD_DEVIATION 3.3 | 32.7 kg/m^2 STANDARD_DEVIATION 2.8 | 31.3 kg/m^2 STANDARD_DEVIATION 3.2 |
| Body fat | 40.9 % STANDARD_DEVIATION 4.3 | 41.7 % STANDARD_DEVIATION 3.8 | 40.2 % STANDARD_DEVIATION 4.7 |
| Breastfeed ever No | 9 Participants | 5 Participants | 4 Participants |
| Breastfeed ever Yes | 26 Participants | 11 Participants | 15 Participants |
| Current smoker No | 31 Participants | 13 Participants | 18 Participants |
| Current smoker Yes | 4 Participants | 3 Participants | 1 Participants |
| Diastolic blood pressure | 74.5 mmHg STANDARD_DEVIATION 9.7 | 73.9 mmHg STANDARD_DEVIATION 10.1 | 74.6 mmHg STANDARD_DEVIATION 9.2 |
| Education 1-3 college | 14 Participants | 9 Participants | 5 Participants |
| Education College degree | 8 Participants | 3 Participants | 5 Participants |
| Education High school diploma/General education development | 9 Participants | 3 Participants | 6 Participants |
| Education Postgraduate | 3 Participants | 1 Participants | 2 Participants |
| Education Some high school | 1 Participants | 0 Participants | 1 Participants |
| Enrollment weight | 85.9 kg STANDARD_DEVIATION 12 | 88.4 kg STANDARD_DEVIATION 9.7 | 83.8 kg STANDARD_DEVIATION 13.5 |
| Gestational weight gain | 14.7 kg STANDARD_DEVIATION 8.6 | 15.2 kg STANDARD_DEVIATION 8 | 14.3 kg STANDARD_DEVIATION 9.2 |
| Marital status Married | 8 Participants | 3 Participants | 5 Participants |
| Marital status Not married and living with significant other | 9 Participants | 3 Participants | 6 Participants |
| Marital status Separated/divorced | 1 Participants | 1 Participants | 0 Participants |
| Marital status Single | 17 Participants | 9 Participants | 8 Participants |
| Parity | 1.8 pregnancies STANDARD_DEVIATION 1.2 | 2 pregnancies STANDARD_DEVIATION 1.3 | 1.6 pregnancies STANDARD_DEVIATION 1 |
| Preconception weight | 80.4 kg STANDARD_DEVIATION 14.2 | 79.9 kg STANDARD_DEVIATION 17.4 | 80.7 kg STANDARD_DEVIATION 9.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 14 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Female | 35 Participants | 16 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Systolic blood pressure | 117.2 mmHg STANDARD_DEVIATION 13.2 | 116.7 mmHg STANDARD_DEVIATION 12.6 | 117.5 mmHg STANDARD_DEVIATION 13.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 19 | 1 / 16 |
| serious Total, serious adverse events | 0 / 19 | 0 / 16 |
Outcome results
Primary
Body Weight Change
The primary outcome measure is weight change after the 16 week intervention.
Time frame: Baseline and 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WIC E-Moms | Body Weight Change | -0.1 kg | Standard Error 0.9 |
| WIC Moms | Body Weight Change | 1.8 kg | Standard Error 0.9 |
Post Hoc
Changes in % Body Fat in WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers.
Changes in % body fat from baseline (week 0) stratified by adherence to the E-Moms intervention and usual care (WIC Moms).
Time frame: Baseline and 16 weeks
Population: All participants stratified by adherence to the E-Moms intervention and usual care (WIC Moms)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WIC E-Moms | Changes in % Body Fat in WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers. | 1.1 % body fat | Standard Error 0.9 |
| WIC Moms | Changes in % Body Fat in WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers. | 0.9 % body fat | Standard Error 0.9 |
| High Adherers | Changes in % Body Fat in WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers. | -2.5 % body fat | Standard Error 1 |
| WIC Moms | Changes in % Body Fat in WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers. | 1.7 % body fat | Standard Error 0.6 |
Post Hoc
Changes in Hip Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers
Changes in hip circumference from baseline (Week 0) stratified by adherence to the E-Moms intervention and usual care (WIC Moms).
Time frame: Baseline and 16 weeks
Population: All participants stratified by adherence to the E-Moms intervention and usual care (WIC Moms)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WIC E-Moms | Changes in Hip Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers | 2.8 cm | Standard Error 1.4 |
| WIC Moms | Changes in Hip Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers | 0.96 cm | Standard Error 1.44 |
| High Adherers | Changes in Hip Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers | -5.0 cm | Standard Error 1.7 |
| WIC Moms | Changes in Hip Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers | 0.62 cm | Standard Error 0.95 |
Post Hoc
Changes in Waist Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers
Changes in waist circumference from baseline (week 0) stratified by adherence to the E-Moms intervention and usual care (WIC Moms)
Time frame: Baseline and 16 weeks
Population: All participants stratified by adherence to the E-Moms intervention and usual care (WIC Moms)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WIC E-Moms | Changes in Waist Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers | 2.6 cm | Standard Error 2.2 |
| WIC Moms | Changes in Waist Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers | -2.5 cm | Standard Error 0.96 |
| High Adherers | Changes in Waist Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers | -4.1 cm | Standard Error 2.6 |
| WIC Moms | Changes in Waist Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers | 0.99 cm | Standard Error 1.48 |