Back to resultsA Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity (Healthy Mamas)
Primary Purpose
Gestational Weight Gain, Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Maintenance Group
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Weight Gain focused on measuring Pregnancy, Body Composition
Eligibility Criteria
Inclusion Criteria:
- Are pregnant less than or equal to 15 weeks gestation at screening
- Have a body mass index between 35.0 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
Sites / Locations
- California Polytechnic State UniversityRecruiting
- Pennington Biomedical Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Weight Maintenance Group
Provider Directed Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Body weight change from early pregnancy to end of pregnancy
Body weight will be measured using a calibrated electrical scale with participants wearing a hospital gown and underwear.
Fat mass change from early pregnancy to end of pregnancy
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.
Total body water change from early pregnancy to end of pregnancy
Total body water is assessed by deuterium dilution.
Fat-free mass change from early pregnancy to end of pregnancy
Fat-free mass will be calculated as the subtraction of fat mass from total body weight.
Body weight change from early pregnancy to approximately 2 weeks postpartum
Body weight will be measured using a calibrated electrical scale with participants wearing a hospital gown and underwear.
Fat mass change from early pregnancy to approximately 2 weeks postpartum
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.
Total body water change from early pregnancy to approximately 2 weeks postpartum
Total body water is assessed by deuterium dilution.
Fat-free mass change from early pregnancy to approximately 2 weeks postpartum
Fat-free mass will be calculated as the subtraction of fat mass from total body weight.
Secondary Outcome Measures
Full Information
NCT ID
NCT04731688
First Posted
January 26, 2021
Last Updated
August 28, 2023
Sponsor
Pennington Biomedical Research Center
Collaborators
California Polytechnic State University-San Luis Obispo, Oregon Health and Science University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT04731688
Brief Title
A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity
Acronym
Healthy Mamas
Official Title
A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
California Polytechnic State University-San Luis Obispo, Oregon Health and Science University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 equally randomized within site (50 individuals at Pennington Biomedical Research Center and 50 individuals at California Polytechnic University) and obesity grade 2 or 3 to either: Provider Directed Group or Weight Maintenance Group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Weight Gain, Obesity
Keywords
Pregnancy, Body Composition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two site randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Outcome assessments will be conducted by staff members who are masked to the participant's intervention group assignment.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Weight Maintenance Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Provider Directed Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Weight Maintenance Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body weight change from early pregnancy to end of pregnancy
Description
Body weight will be measured using a calibrated electrical scale with participants wearing a hospital gown and underwear.
Time Frame
13-16 weeks gestation and 35-37 weeks gestation
Title
Fat mass change from early pregnancy to end of pregnancy
Description
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.
Time Frame
13-16 weeks gestation and 35-37 weeks gestation
Title
Total body water change from early pregnancy to end of pregnancy
Description
Total body water is assessed by deuterium dilution.
Time Frame
13-16 weeks gestation and 35-37 weeks gestation
Title
Fat-free mass change from early pregnancy to end of pregnancy
Description
Fat-free mass will be calculated as the subtraction of fat mass from total body weight.
Time Frame
13-16 weeks gestation and 35-37 weeks gestation
Title
Body weight change from early pregnancy to approximately 2 weeks postpartum
Description
Body weight will be measured using a calibrated electrical scale with participants wearing a hospital gown and underwear.
Time Frame
13-16 weeks gestation and approximately 2 weeks postpartum
Title
Fat mass change from early pregnancy to approximately 2 weeks postpartum
Description
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.
Time Frame
13-16 weeks gestation and approximately 2 weeks postpartum
Title
Total body water change from early pregnancy to approximately 2 weeks postpartum
Description
Total body water is assessed by deuterium dilution.
Time Frame
13-16 weeks gestation and approximately 2 weeks postpartum
Title
Fat-free mass change from early pregnancy to approximately 2 weeks postpartum
Description
Fat-free mass will be calculated as the subtraction of fat mass from total body weight.
Time Frame
13-16 weeks gestation and approximately 2 weeks postpartum
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
100 pregnant women with obesity will be enrolled.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abby D Altazan, M.S.
Phone
225-763-2801
Email
Abby.Altazan@pbrc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Madison S Dickey, M.S.
Phone
225-763-2725
Email
Madison.Dickey@pbrc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leanne M Redman, Ph.D.
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Polytechnic State University
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casey Heaney, M.S.
Phone
805-756-5365
Email
heaney@calpoly.edu
First Name & Middle Initial & Last Name & Degree
Suzanne Phelan, Ph.D.
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abby D Altazan, M.S.
Phone
225-763-2801
Email
Abby.Altazan@pbrc.edu
First Name & Middle Initial & Last Name & Degree
Leanne M Redman, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity
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