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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social network building intervention | Experimental | Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members |
|
| Home visit | Active Comparator | Home visits focused on preventable infant injuries |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social network building intervention | Behavioral | Group support and 12 weekly health education/skills building sessions during pregnancy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | Duration of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 times over 12 weeks (Week 6, Week 12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabina B Gesell, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coleman Regional Community Center- Parks & Rec Department | Nashville | Tennessee | 37211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25649967 | Result | Arinze NV, Karp SM, Gesell SB. Evaluating Provider Advice and Women's Beliefs on Total Weight Gain During Pregnancy. J Immigr Minor Health. 2016 Feb;18(1):282-6. doi: 10.1007/s10903-015-0162-8. | |
| 26577514 | Result | Tesdahl E, Gesell SB. Assessing the Impact of De Novo Social Ties within Health Intervention Settings: New Questions for Health Behavior Intervention Research. Clin Transl Sci. 2015 Dec;8(6):676-81. doi: 10.1111/cts.12345. Epub 2015 Nov 18. |
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An individual participant data set ("The Madre Sana Data Set") and codebook are publically available and can be downloaded at:
http://www.insna.org/connections/v35/v35\_2\_6.html Citation: Gesell SB, Tesdahl E. Data Exchange Network: The "Madre Sana" data set. Connections 2016, 35 (2), 62-65.
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147 were consented; 12 withdrew consent before randomization (reason: too much time to commit); 135 were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Home Visit | Home visits focused on preventable infant injuries Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.) | 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). | Posted | Count of Participants | Participants | Duration of pregnancy |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Pilot study; Low session attendance; Missing data from medical record abstractions; Loss to follow-up, possibly due to not requiring participants to attend two baseline visits prior to randomization; Generalizability may be limited to Latina women
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sabina B. Gesell | Wake Forest School of Medicine | 336-713-8738 | sgesell@wakehealth.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D000078064 | Gestational Weight Gain |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D006792 | House Calls |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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|
| Home visit | Behavioral | Three home visits during pregnancy focused on providing education on infant injury prevention |
|
| 25874878 | Result | Gesell SB, Katula JA, Strickland C, Vitolins MZ. Feasibility and Initial Efficacy Evaluation of a Community-Based Cognitive-Behavioral Lifestyle Intervention to Prevent Excessive Weight Gain During Pregnancy in Latina Women. Matern Child Health J. 2015 Aug;19(8):1842-52. doi: 10.1007/s10995-015-1698-x. |
| 27812234 | Result | Gesell SB, Tesdahl EA. The "Madre Sana" Data Set. Connect (Tor). 2015;35(2):62-65. doi: 10.17266/35.2.6. No abstract available. |
| Home Visit |
Home visits focused on preventable infant injuries Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Language preference | Count of Participants | Participants |
|
| Baseline Body Mass Index Category | Number | participants |
|
| OG001 | Home Visit | Home visits focused on preventable infant injuries Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | number of discussion partner ties | 2 times over 12 weeks (Week 6, Week 12) |
|
|
|
| 0 |
| 68 |
| 0 |
| 68 |
| EG001 | Home Visit | Home visits focused on preventable infant injuries Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention | 0 | 67 | 0 | 67 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| Within IOM recommendations |
|
| Over IOM recommendations |
|
| Within IOM recommendations |
|
| Over IOM recommendations |
|
| Within IOM recommendations |
|
| Over IOM recommendations |
|
| Within IOM recommendations |
|
| Over IOM recommendations |
|