Clinical trial NCT04731688: A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity
Official title: A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gestational Weight Gain
Obesity
Keywords: Pregnancy
Body Composition
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: California Polytechnic State University-San Luis Obispo
name: Oregon Health and Science University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-02-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two site randomized controlled trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Are pregnant less than or equal to 15 weeks gestation at screening
* Have a body mass index between 31.0 and 55.0 inclusive
* Have a confirmed viable singleton gestation
* Willing to receive randomization to either group
* Willing and able to eat the study foods
* Willing to enroll infant for study measurements after birth
* Receive clearance from the prenatal care provider for participation

Exclusion Criteria:

* Smoking, drug, or alcohol use
* Have a known fetal anomaly
* Have a non-pregnancy related illness
* Have pre-existing diabetes
* Have pre-existing hypertension
* Have severe anemia
* Have current mental health issue or eating disorder
* Short inter-pregnancy interval (\<6 months since last pregnancy)
* Use of assisted reproductive technology
* Use of medications with known effects on body weight including over the counter medications and supplements for weight loss
* History of pre-eclampsia, prior small for gestational age infant, bariatric surgery
* Planning to move out of the area in the next 12 months

Primary outcomes:
measure: Body weight
timeFrame: From study entry to approximately 2 weeks postpartum
Secondary outcomes:
measure: Fat mass
timeFrame: From study entry to approximately 2 weeks postpartum
Other outcomes:
measure: Total body water
timeFrame: From study entry to approximately 2 weeks postpartum
measure: Fat-free mass
timeFrame: From study entry to approximately 2 weeks postpartum
measure: Fetal weight
timeFrame: From 19-22 weeks gestation to 39-42 weeks gestation
measure: Infant body composition
timeFrame: Approximately 2 weeks old
measure: Dietary intake
timeFrame: From study entry to 35-37 weeks gestation
measure: Time Spent in Physical activity
timeFrame: From study entry to 35-37 weeks gestation
measure: Metabolic syndrome score
timeFrame: From study entry to approximately 2 weeks postpartum
measure: Perinatal outcomes
timeFrame: From study entry to approximately 2 weeks postpartum
Locations:
city: San Luis Obispo
country: United States
facility: California Polytechnic State University
state: California
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Leanne M Redman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: