Study Summary
This trial will study the effects of a lifestyle program on pregnant women with obesity. The program is designed to help with weight maintenance and fat loss, and researchers will track changes in weight, fat mass, cardiometabolic risk factors, and safety measures like fetal and neonatal growth. They will also study the factors that affect how well the program works, and whether the fat loss leads to better obstetrical outcomes.
Eligible Conditions
- Obesity
- Gestational Weight Gain
Treatment Effectiveness
Effectiveness Progress
Study Objectives
8 Primary · 0 Secondary · Reporting Duration: 13-16 weeks gestation and 35-37 weeks gestation
Week 37
Body weight change from early pregnancy to end of pregnancy
Fat mass change from early pregnancy to end of pregnancy
Fat-free mass change from early pregnancy to end of pregnancy
Total body water change from early pregnancy to end of pregnancy
Week 16
Body weight change from early pregnancy to approximately 2 weeks postpartum
Fat mass change from early pregnancy to approximately 2 weeks postpartum
Fat-free mass change from early pregnancy to approximately 2 weeks postpartum
Total body water change from early pregnancy to approximately 2 weeks postpartum
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Provider Directed Group
1 of 2
Weight Maintenance Group
1 of 2
Active Control
Experimental Treatment
100 Total Participants · 2 Treatment Groups
Primary Treatment: Weight Maintenance Group · No Placebo Group · N/A
Weight Maintenance Group
Behavioral
Experimental Group · 1 Intervention: Weight Maintenance Group · Intervention Types: BehavioralProvider Directed GroupNoIntervention Group · 1 Intervention: Provider Directed Group · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 13-16 weeks gestation and 35-37 weeks gestation
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,141 Previous Clinical Trials
4,064,375 Total Patients Enrolled
401 Trials studying Obesity
492,665 Patients Enrolled for Obesity
Pennington Biomedical Research CenterLead Sponsor
267 Previous Clinical Trials
166,301 Total Patients Enrolled
56 Trials studying Obesity
115,076 Patients Enrolled for Obesity
Oregon Health and Science UniversityOTHER
893 Previous Clinical Trials
6,829,377 Total Patients Enrolled
27 Trials studying Obesity
8,832 Patients Enrolled for Obesity
California Polytechnic State University-San Luis ObispoOTHER
25 Previous Clinical Trials
2,725 Total Patients Enrolled
7 Trials studying Obesity
1,279 Patients Enrolled for Obesity
Leanne M Redman, Ph.D.Principal InvestigatorPennington Biomedical Research Center
8 Previous Clinical Trials
1,682 Total Patients Enrolled
Eligibility Criteria
Age 18 - 45 · Female Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The participants in the study were willing and able to eat the study foods.
The text is saying that the researchers are willing to enroll an infant for study measurements after birth.
?
Less than or equal to 15 weeks gestation at screening means that the woman is pregnant and the baby is less than or equal to 15 weeks old.
Have a body mass index of between 35 and 55.
You have a confirmed viable singleton pregnancy.\n
I am willing to be randomized to either group.
Who else is applying?
What state do they live in?
| Louisiana | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Pennington Biomedical Research Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments