Obesity
Conditions
Keywords
Postpartum weight retention, Low income women, WIC, Online
Brief summary
This study will examine the effects of an online behavioral intervention to promote weight loss in low income postpartum women in the WIC program.
Detailed description
This program is designed to reduce postpartum weight retention in low income women in the WIC program. The weight loss program will be delivered over the internet and will use behavioral weight loss techniques.
Interventions
BEHAVIORALOnline postpartum weight control
The intervention group will be given access to an online weight loss program supplemented by monthly group meetings.
Sponsors
University of North Carolina, Chapel Hill
California Polytechnic State University-San Luis Obispo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Women * Age 18-40 years. * Delivery within 6-52 weeks * Exceed pre-pregnancy weight by at least 4.5 kg (10 pounds) or current body mass index (BMI) \>/= 25 * Current BMI \> 22 * English or Spanish speaking * Has internet access at home or a landline * Literacy of at least 5th grade reading level * Has a cell phone
Exclusion criteria
* Pregnant or planning to become pregnant * Relocating in the next year * Serious psychological problems (untreated depression, schizophrenia, bipolar disorder) or medical problem (i.e. heart disease, cancer, renal disease and diabetes), for which physician supervision of diet and exercise prescription is needed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 12 months | Women randomized to the weight loss group will be assessed over time at study entry, 6 months, and 12 months. The primary outcome is change from entry to the endpoint at 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Calorie Intake | 12 months | Calorie intake was measured over time at study entry, 6 and 12 months. The primary outcome is change from entry to 12 months. |
Countries
United States
Participant flow
Recruitment details
12 WIC Clinics Recruited; 371 participants total across all clinics
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention.
Online postpartum weight control: The intervention group will be given access to an online weight loss program supplemented by monthly group meetings. | 174 |
| Standard WIC Care The control group will received Standard Care as provided through WIC. | 197 |
| Total | 371 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Treatment Group | Standard WIC Care | Total |
|---|---|---|---|
| Age, Continuous | 27.5 years STANDARD_DEVIATION 5.2 | 28.6 years STANDARD_DEVIATION 5.5 | 28.1 years STANDARD_DEVIATION 5.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 146 Participants | 157 Participants | 303 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 40 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 174 Participants | 196 Participants | 370 Participants |
| Sex: Female, Male Female | 174 Participants | 197 Participants | 371 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 174 | 15 / 196 |
| serious Total, serious adverse events | 0 / 174 | 0 / 196 |
Outcome results
Primary
Weight
Women randomized to the weight loss group will be assessed over time at study entry, 6 months, and 12 months. The primary outcome is change from entry to the endpoint at 12 months.
Time frame: 12 months
Population: This cluster randomized trial included 11 clinics. Participant numbers reflect number of people randomized within the clinics.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Treatment Group | Weight | -3.2 kg |
| Standard WIC Care | Weight | -0.9 kg |
Comparison: To test the primary hypothesis, a generalized linear mixed effect model was used (intervention group as a fixed effect and clinic and subject as random effects). A group x time interaction term (fixed effect) tested if the change in weight over time differed significantly. The model included participant-level covariates (i.e., ethnicity, weeks postpartum at study entry, lactation, and age).p-value: <0.0001Mixed Models Analysis
Secondary
Calorie Intake
Calorie intake was measured over time at study entry, 6 and 12 months. The primary outcome is change from entry to 12 months.
Time frame: 12 months
Population: 12 clusters were randomized. Sample size above reflect total number of participants in each group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Treatment Group | Calorie Intake | -298 kcal/day |
| Standard WIC Care | Calorie Intake | -144 kcal/day |