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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK124806-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| California Polytechnic State University-San Luis Obispo | OTHER |
| Oregon Health and Science University | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The aims of this randomized controlled trial are to determine the effects of a lifestyle program that supports weight maintenance and fat mass loss during pregnancy in women with obesity on changes in 1) maternal weight, fat mass, and cardiometabolic risk factors; 2) safety measures, including fetal and neonatal growth; 3) the mediators and moderators of the fat mass loss intervention and 4) the effects gestational fat mass loss has on reducing incidence of adverse obstetrical outcomes, including non-elective cesarean delivery, gestational diabetes, hypertension, and pre-eclampsia.
One hundred pregnant women with obesity who are otherwise healthy will be studied from early pregnancy until approximately 2 weeks postpartum. Major assessments will occur at baseline (13-16 weeks gestation), 27-29 weeks gestation, 35-37 weeks gestation, and approximately 2 weeks postpartum. Safety assessments will be collected every 4 weeks after enrollment. Participants will be randomized within site (approximately 50 individuals at Pennington Biomedical Research Center and approximately 50 individuals at California Polytechnic University) and obesity to either: Provider Directed Group or Weight Maintenance Group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Maintenance Group | Experimental | Individuals in this group will receive all aspects of the Provider Directed Group plus a comprehensive behavioral fat mass loss intervention with food provision. Individuals in this group will be provided foods to eat to support weight maintenance and loss of body fat throughout pregnancy. They will be asked to attend two behavioral counseling sessions at the beginning of the study to help learn the program and set goals. They will return for brief visits with a lifestyle counselor every two weeks until 20 weeks gestation and at least once a month until delivery. Individuals will be provided a scale to help keep track of weight during pregnancy. |
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| Provider Directed Group | No Intervention | Individuals in this group will receive what is standard practice by their prenatal care providers during pregnancy. In addition, individuals in this group will be asked to attend a brief session at the time of randomization to familiarize with the study and what is expected. They will also be provided with materials describing healthy behaviors in pregnancy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Maintenance Group | Behavioral | The behavioral program is rooted in social learning theory and based on our existing prenatal intervention but with full food provision to ensure gestational fat mass loss is steady and closely supervised. Brief counseling sessions are designed to review self-monitoring records, reinforce adherence to the structured food provision program, problem-solve barriers, and provide additional support. Individuals will be provided with a structured meal plan designed to promote 25% calorie restriction during the second trimester followed by eucaloric intake during the 3rd trimester. Participants will be provided three meals and two snacks on 7 days at no cost. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Body weight will be measured using a calibrated electrical scale with participants wearing a hospital gown and underwear. | From study entry to approximately 2 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Fat mass | Fat mass will be assessed via a 3-compartment model in which fat mass is calculated from body weight, body density measured by the BODPOD, and total body water measured by deuterium dilution. | From study entry to approximately 2 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Total body water | Total body water is assessed by deuterium dilution. | From study entry to approximately 2 weeks postpartum |
| Fat-free mass | Fat-free mass will be calculated as the subtraction of fat mass from total body weight. |
Inclusion Criteria:
Exclusion Criteria:
100 pregnant women with obesity will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Leanne M Redman, Ph.D. | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Polytechnic State University | San Luis Obispo | California | 93407 | United States | ||
| Pennington Biomedical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40000086 | Derived | Redman LM, Phelan S, Apolzan JW, Beyl RA, Altazan AD, Dickey MS, Simeon E, Flanagan EW, Cabre HE, Sparks JR, Kebbe M, Caughey AB, Valent AM, Hsia DS, Yin E, Keadle SK. Protocol for a randomised controlled trial of a weight maintenance intervention to promote fat loss in pregnant individuals with obesity. BMJ Open. 2025 Feb 25;15(2):e095804. doi: 10.1136/bmjopen-2024-095804. |
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| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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Two site randomized controlled trial
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Outcome assessments will be conducted by staff members who are masked to the participant's intervention group assignment.
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| From study entry to approximately 2 weeks postpartum |
| Fetal weight | Fetal weight is measured by ultrasound and estimated by Hadlock formula. | From 19-22 weeks gestation to 39-42 weeks gestation |
| Infant body composition | Infant body composition will be assessed via a 3-compartment model which includes body weight, PEAPOD, and dual-energy x-ray absorptiometry. | Approximately 2 weeks old |
| Dietary intake | Dietary intake is assessed by automated self-administered 24-hour dietary assessment tool (ASA-24). | From study entry to 35-37 weeks gestation |
| Time Spent in Physical activity | Physical activity (amount of time spent in physical activity) is assessed by activPAL activity device over a period of 5-7 days. | From study entry to 35-37 weeks gestation |
| Metabolic syndrome score | Metabolic syndrome score will be determined using measured blood pressure and waist circumference, and triglycerides, high density lipoprotein cholesterol, and glucose. | From study entry to approximately 2 weeks postpartum |
| Perinatal outcomes | All perinatal outcomes (ie non-elective cesarean delivery, gestational diabetes, hypertension, pre-eclampsia) will be obtained by prenatal and delivery medical chart abstraction. | From study entry to approximately 2 weeks postpartum |
| Baton Rouge |
| Louisiana |
| 70808 |
| United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |