Obesity, Pregnancy
Conditions
Keywords
gestational weight gain
Brief summary
The purpose of this study is to examine whether we can use social networks to spread health information and health behaviors during pregnancy to prevent excessive gestational weight gain.
Detailed description
The long-term goal of this research is to prevent obesity-related adverse health outcomes for future generations by applying information emerging from social network studies to the development of new population-based behavioral interventions. There are a number of critical periods during fetal development that appear to influence the later development of obesity. Interventions that prevent insult to these critical windows from occurring could improve children's life course trajectories. This project sets the groundwork for examining whether social networks could explicitly be utilized to support women in gaining weight during pregnancy within their clinically recommended weight gain target.
Interventions
BEHAVIORALSocial network building intervention
Group support and 12 weekly health education/skills building sessions during pregnancy
BEHAVIORALHome visit
Three home visits during pregnancy focused on providing education on infant injury prevention
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* any race/ethnicity * speak Spanish or English * ≥16 years * \>10 and \<28 weeks pregnant * in prenatal care * anticipating remaining in Middle Tennessee for their full gestation * willing to sign a medical information release form so that we can abstract weight measures from their obstetric and pediatric records
Exclusion criteria
* speak neither Spanish or English * \<16 years * \< 10 weeks or \>28 weeks pregnant * not in prenatal care * anticipating leaving Middle Tennessee before full gestation * unwilling to sign medical information release form * current or past (within last 12 months) enrollment in another research program that targets weight, physical activity, nutrition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational Weight Gain | Duration of pregnancy | Total weight gain during pregnancy extracted from medical record, relative to the 2009 Institute of Medicine (IOM) Weight Gain Recommendations for Pregnancy. (Reference: Institute of Medicine (US). Weight gain during pregnancy: reexamining the guidelines. Washington, DC. National Academies Press; 2009. 2009 National Academy of Sciences.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Network | 2 times over 12 weeks (Week 6, Week 12) | Number of discussion partners within the intervention group. Participants were asked to identify by name any program participants with whom they had spoken about their pregnancy or pregnancy-related health behaviors. |
Countries
United States
Participant flow
Pre-assignment details
147 were consented; 12 withdrew consent before randomization (reason: too much time to commit); 135 were randomized
Participants by arm
| Arm | Count |
|---|---|
| Social Network Building Intervention Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members
Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy | 68 |
| Home Visit Home visits focused on preventable infant injuries
Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention | 67 |
| Total | 135 |
Baseline characteristics
| Characteristic | Home Visit | Total | Social Network Building Intervention |
|---|---|---|---|
| Age, Continuous | 26.3 years STANDARD_DEVIATION 5.9 | 26.2 years STANDARD_DEVIATION 5.9 | 26.1 years STANDARD_DEVIATION 5.9 |
| Baseline Body Mass Index Category Normal weight | 27 participants | 53 participants | 26 participants |
| Baseline Body Mass Index Category Obese | 17 participants | 36 participants | 19 participants |
| Baseline Body Mass Index Category Overweight | 23 participants | 46 participants | 23 participants |
| Baseline Body Mass Index Category Underweight | 0 participants | 0 participants | 0 participants |
| Language preference English | 17 Participants | 37 Participants | 20 Participants |
| Language preference English AND Spanish | 2 Participants | 9 Participants | 7 Participants |
| Language preference Spanish | 48 Participants | 89 Participants | 41 Participants |
| Race/Ethnicity, Customized African-American | 6 Participants | 21 Participants | 15 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 5 Participants | 6 Participants | 1 Participants |
| Race/Ethnicity, Customized Latina | 50 Participants | 98 Participants | 48 Participants |
| Race/Ethnicity, Customized Not self-identified | 4 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 5 Participants | 3 Participants |
| Region of Enrollment United States | 67 participants | 135 participants | 68 participants |
| Sex: Female, Male Female | 67 Participants | 135 Participants | 68 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 | 0 / 68 | 0 / 67 |
| serious Total, serious adverse events | 0 / 68 | 0 / 67 |
Outcome results
Primary
Gestational Weight Gain
Total weight gain during pregnancy extracted from medical record, relative to the 2009 Institute of Medicine (IOM) Weight Gain Recommendations for Pregnancy. (Reference: Institute of Medicine (US). Weight gain during pregnancy: reexamining the guidelines. Washington, DC. National Academies Press; 2009. 2009 National Academy of Sciences.)
Time frame: Duration of pregnancy
Population: Analysis is presented within baseline BMI categories and overall. The Overall Number of Participants Analyzed represents those study participants for whom medical records could be abstracted in the trial (87/135).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Social Network Building Intervention | Gestational Weight Gain | Underweight (pre-pregnancy BMI) | Under IOM recommendations | 0 Participants |
| Social Network Building Intervention | Gestational Weight Gain | Normal weight (pre-pregnancy BMI) | Within IOM recommendations | 6 Participants |
| Social Network Building Intervention | Gestational Weight Gain | Overweight (pre-pregnancy BMI) | Over IOM recommendations | 4 Participants |
| Social Network Building Intervention | Gestational Weight Gain | All (pre-pregnancy BMI) | Under IOM recommendations | 15 Participants |
| Social Network Building Intervention | Gestational Weight Gain | All (pre-pregnancy BMI) | Over IOM recommendations | 12 Participants |
| Social Network Building Intervention | Gestational Weight Gain | All (pre-pregnancy BMI) | Within IOM recommendations | 17 Participants |
| Social Network Building Intervention | Gestational Weight Gain | Underweight (pre-pregnancy BMI) | Within IOM recommendations | 0 Participants |
| Social Network Building Intervention | Gestational Weight Gain | Underweight (pre-pregnancy BMI) | Over IOM recommendations | 0 Participants |
| Social Network Building Intervention | Gestational Weight Gain | Normal weight (pre-pregnancy BMI) | Under IOM recommendations | 8 Participants |
| Social Network Building Intervention | Gestational Weight Gain | Normal weight (pre-pregnancy BMI) | Over IOM recommendations | 1 Participants |
| Social Network Building Intervention | Gestational Weight Gain | Overweight (pre-pregnancy BMI) | Under IOM recommendations | 3 Participants |
| Social Network Building Intervention | Gestational Weight Gain | Overweight (pre-pregnancy BMI) | Within IOM recommendations | 7 Participants |
| Social Network Building Intervention | Gestational Weight Gain | Obese (pre-pregnancy BMI) | Under IOM recommendations | 4 Participants |
| Social Network Building Intervention | Gestational Weight Gain | Obese (pre-pregnancy BMI) | Within IOM recommendations | 4 Participants |
| Social Network Building Intervention | Gestational Weight Gain | Obese (pre-pregnancy BMI) | Over IOM recommendations | 7 Participants |
| Home Visit | Gestational Weight Gain | All (pre-pregnancy BMI) | Under IOM recommendations | 13 Participants |
| Home Visit | Gestational Weight Gain | Normal weight (pre-pregnancy BMI) | Under IOM recommendations | 6 Participants |
| Home Visit | Gestational Weight Gain | Normal weight (pre-pregnancy BMI) | Over IOM recommendations | 8 Participants |
| Home Visit | Gestational Weight Gain | Normal weight (pre-pregnancy BMI) | Within IOM recommendations | 3 Participants |
| Home Visit | Gestational Weight Gain | Overweight (pre-pregnancy BMI) | Over IOM recommendations | 6 Participants |
| Home Visit | Gestational Weight Gain | Obese (pre-pregnancy BMI) | Under IOM recommendations | 1 Participants |
| Home Visit | Gestational Weight Gain | All (pre-pregnancy BMI) | Within IOM recommendations | 11 Participants |
| Home Visit | Gestational Weight Gain | Obese (pre-pregnancy BMI) | Over IOM recommendations | 5 Participants |
| Home Visit | Gestational Weight Gain | Overweight (pre-pregnancy BMI) | Under IOM recommendations | 6 Participants |
| Home Visit | Gestational Weight Gain | All (pre-pregnancy BMI) | Over IOM recommendations | 19 Participants |
| Home Visit | Gestational Weight Gain | Underweight (pre-pregnancy BMI) | Under IOM recommendations | 0 Participants |
| Home Visit | Gestational Weight Gain | Obese (pre-pregnancy BMI) | Within IOM recommendations | 5 Participants |
| Home Visit | Gestational Weight Gain | Underweight (pre-pregnancy BMI) | Within IOM recommendations | 0 Participants |
| Home Visit | Gestational Weight Gain | Overweight (pre-pregnancy BMI) | Within IOM recommendations | 3 Participants |
| Home Visit | Gestational Weight Gain | Underweight (pre-pregnancy BMI) | Over IOM recommendations | 0 Participants |
Secondary
Social Network
Number of discussion partners within the intervention group. Participants were asked to identify by name any program participants with whom they had spoken about their pregnancy or pregnancy-related health behaviors.
Time frame: 2 times over 12 weeks (Week 6, Week 12)
Population: 59 participants in the intervention group completed at least one wave of social network data collection. Control group participants did not have protocol-specified group sessions to evaluate.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social Network Building Intervention | Social Network | 3.56 number of discussion partner ties | Standard Deviation 2.11 |