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The study will use a comprehensive behavioral intervention adapted for pregnant women to change dietary intake, eating behavior and physical activity. The central hypothesis of this study is that the intervention will reduce excess gestational weight gain and achieve clinical and metabolic benefits in obese and overweight pregnant women and their infants over the first year of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiber Cereal | Active Comparator | Women assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided high fiber cereal to manage hunger. |
|
| Control Group | No Intervention | Women assigned to this arm of the study will receive routine clinical care and no additional interventions. | |
| Resistant Starch | Active Comparator | Women assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided resistant starch to control hunger |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention to reduce excess weight gain during pregnancy | Behavioral | Intervention includes meetings with a nutrition counselor and/or psychologist where individualized eating plans will be developed and reviewed, and regular group meetings during which information about healthy eating for weight management will be discussed. |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal and Infant Body Weight Change |
| From first trimester through 1 year post-partum |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Outcomes |
| From birth through first year |
| Maternal and Perinatal Outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan B Roberts, Ph.D. | Tufts University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States | ||
| Tufts University Human Nutrition Research Center on Aging |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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|
|
| First trimester through 1 year post-partum |
| Boston |
| Massachusetts |
| 02111 |
| United States |
| D013568 | Pathological Conditions, Signs and Symptoms |