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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL114377 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Brown University | OTHER |
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The purpose of this study is to study the effects of a multicomponent lifestyle intervention that includes partial meal replacements as a means to prevent excessive gestational weight gain in obese women. The primary hypothesis is that the intervention will reduce the rate of gestational weight gain compared with standard care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | No Intervention | ||
| Lifestyle intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention | Behavioral | The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain Per Week of Observation | Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used. | 13 weeks gestation, 35 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Offspring Weight Gain | Offspring weight for age z scores from birth (1 week), to 6 months, and 12 months of age. | 1 week, 6 months, 12 months |
| Kcals/Day | Changes in maternal calorie intake (Kcal/day) |
Not provided
Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Phelan, PhD | Cal Poly | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Polytechnic State University | San Luis Obispo | California | 93401 | United States | ||
| Miriam Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41029405 | Derived | Cabre HE, Drews KL, Pomeroy J, Keadle SK, Arteaga SS, Franks PW, Haire-Joshu D, Knowler WC, Pi-Sunyer X, Van Horn L, Wing RR, Cahill AG, Clifton RG, Couch KA, Gallager D, Josefson JL, Joshipura K, Klein S, Martin CK, Peaceman AM, Phelan S, Thom EA, Redman LM; LIFE-Moms Research Group. LIFE-Moms: effects of multicomponent lifestyle randomized control trial on physical activity during pregnancy in women with overweight and obesity. Int J Behav Nutr Phys Act. 2025 Sep 30;22(1):119. doi: 10.1186/s12966-025-01805-9. | |
| 40839263 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC) |
| FG001 | Lifestyle Intervention | Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who withdrew (N = 7) are not included in baseline analysis population table or in any results.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC) |
| 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 | Weight Gain Per Week of Observation | Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used. | Posted | Least Squares Mean | Standard Deviation | kg/wk | 13 weeks gestation, 35 weeks gestation |
|
35 weeks gestation
Preterm delivery (< 36 weeks)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care | Participants in the enhanced-usual care group received all aspects of usual care offered by their prenatal care providers, including physicians, nurses, nutritionists, or counselors from the Women, Infants, and Children's Special Supplemental Nutrition Program (WIC) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Preterm Delivery | General disorders | Preterm Delivery | Systematic Assessment | <36 weeks gestation |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzanne Phelan | Cal Poly | 805-756-2087 | sphelan@calpoly.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
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| 13 weeks gestation, 34 weeks gestation |
| Changes in Offspring Dietary Intake | Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day). | 1 week, 6 months, 12 months |
| Changes in Maternal Glucose | Fasting glucose | 13 weeks gestation, 34 weeks gestation |
| Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group. | Self-reported pre-pregnancy weight will be subtracted from weight measured at last clinic visit prior to delivery. Women will be categorized as exceeding 2009 IOM guidelines if the difference is > 11.5 kg gain for women with prepregnancy overweight or >9 kg for women with prepregnancy obesity. | 13 weeks, 40 weeks |
| Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group | Weight measured at 48-56 weeks postpartum and subtracted from self-reported prepregnancy weight and then categorized as at or below vs. above self-reported prepregnancy weight. | 48-56 weeks post delivery |
| Providence |
| Rhode Island |
| 02906 |
| United States |
| Derived |
| Flanagan EW, Drews KL, Cade WT, Franks PW, Gallagher D, Phelan S, Van Horn L, Redman LM. Metabolic Health and Heterogenous Outcomes of Prenatal Interventions: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2528264. doi: 10.1001/jamanetworkopen.2025.28264. |
| 33238176 | Derived | Redman LM, Drews KL, Klein S, Horn LV, Wing RR, Pi-Sunyer X, Evans M, Joshipura K, Arteaga SS, Cahill AG, Clifton RG, Couch KA, Franks PW, Gallagher D, Haire-Joshu D, Martin CK, Peaceman AM, Phelan S, Thom EA, Yanovski SZ, Knowler WC; LIFE-Moms Research Group. Attenuated early pregnancy weight gain by prenatal lifestyle interventions does not prevent gestational diabetes in the LIFE-Moms consortium. Diabetes Res Clin Pract. 2021 Jan;171:108549. doi: 10.1016/j.diabres.2020.108549. Epub 2020 Nov 22. |
| 30421864 | Derived | Phelan S, Wing RR, Brannen A, McHugh A, Hagobian T, Schaffner A, Jelalian E, Hart CN, Scholl TO, Munoz-Christian K, Yin E, Phipps MG, Keadle S, Abrams B. Does Partial Meal Replacement During Pregnancy Reduce 12-Month Postpartum Weight Retention? Obesity (Silver Spring). 2019 Feb;27(2):226-236. doi: 10.1002/oby.22361. Epub 2018 Nov 13. |
| 30230252 | Derived | Peaceman AM, Clifton RG, Phelan S, Gallagher D, Evans M, Redman LM, Knowler WC, Joshipura K, Haire-Joshu D, Yanovski SZ, Couch KA, Drews KL, Franks PW, Klein S, Martin CK, Pi-Sunyer X, Thom EA, Van Horn L, Wing RR, Cahill AG; LIFE-Moms Research Group. Lifestyle Interventions Limit Gestational Weight Gain in Women with Overweight or Obesity: LIFE-Moms Prospective Meta-Analysis. Obesity (Silver Spring). 2018 Sep;26(9):1396-1404. doi: 10.1002/oby.22250. Epub 2018 Sep 6. |
| 29529157 | Derived | Phelan S, Wing RR, Brannen A, McHugh A, Hagobian TA, Schaffner A, Jelalian E, Hart CN, Scholl TO, Munoz-Christian K, Yin E, Phipps MG, Keadle S, Abrams B. Randomized controlled clinical trial of behavioral lifestyle intervention with partial meal replacement to reduce excessive gestational weight gain. Am J Clin Nutr. 2018 Feb 1;107(2):183-194. doi: 10.1093/ajcn/nqx043. |
| 26708836 | Derived | Clifton RG, Evans M, Cahill AG, Franks PW, Gallagher D, Phelan S, Pomeroy J, Redman LM, Van Horn L; LIFE-Moms Research Group. Design of lifestyle intervention trials to prevent excessive gestational weight gain in women with overweight or obesity. Obesity (Silver Spring). 2016 Feb;24(2):305-13. doi: 10.1002/oby.21330. Epub 2015 Dec 26. |
| Lifestyle Intervention |
Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lifestyle Intervention |
Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy. |
|
|
| Secondary | Offspring Weight Gain | Offspring weight for age z scores from birth (1 week), to 6 months, and 12 months of age. | Not Posted | 1 week, 6 months, 12 months | Participants |
| Secondary | Kcals/Day | Changes in maternal calorie intake (Kcal/day) | Posted | Least Squares Mean | 95% Confidence Interval | kcals/day | 13 weeks gestation, 34 weeks gestation |
|
|
|
| Secondary | Changes in Offspring Dietary Intake | Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day). | Not Posted | 1 week, 6 months, 12 months | Participants |
| Secondary | Changes in Maternal Glucose | Fasting glucose | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | 13 weeks gestation, 34 weeks gestation |
|
|
|
| Secondary | Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group. | Self-reported pre-pregnancy weight will be subtracted from weight measured at last clinic visit prior to delivery. Women will be categorized as exceeding 2009 IOM guidelines if the difference is > 11.5 kg gain for women with prepregnancy overweight or >9 kg for women with prepregnancy obesity. | Posted | Count of Participants | Participants | 13 weeks, 40 weeks |
|
|
|
| Secondary | Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group | Weight measured at 48-56 weeks postpartum and subtracted from self-reported prepregnancy weight and then categorized as at or below vs. above self-reported prepregnancy weight. | Posted | Count of Participants | Participants | 48-56 weeks post delivery |
|
|
|
| 0 |
| 128 |
| 5 |
| 128 |
| EG001 | Lifestyle Intervention | Lifestyle intervention: The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy. | 0 | 129 | 4 | 129 |
|
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |