PREPARE: A Randomized Trial of a Pre-pregnancy Weight Loss Intervention
Primary Purpose
Overweight, Obese
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight management
Usual Care Control
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Pre-pregnancy, Weight management
Eligibility Criteria
Inclusion Criteria:
- Current Kaiser Permanente Northwest (KPNW) member
- Expects to be KPNW member for at least 2 more years
- Body Mass Index (BMI) ≥ 27
- Not currently pregnant
- Access to computer with Internet
- Completion of screening diet assessment
- English speaking
Exclusion Criteria:
- Taking medication (insulin or pills) for treatment of diabetes
- Gastrointestinal disease requiring special diet or medications (for example, ulcerative colitis, celiac sprue, phenylketonuria)
- Currently receiving treatment for cancer
- Renal disease (kidney disease requiring special diet or medication)
- History of bariatric surgery
- Use of prescription weight loss medications in the last three months
- Another household member already participating in the Prepare study
Sites / Locations
- Anna Edelmann
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Usual Care Control
Arm Description
Weight management intervention
Usual Care for planning healthy pregnancy
Outcomes
Primary Outcome Measures
Reduced pregnancy-related weight gain
Secondary Outcome Measures
Lower weight at the start of pregnancy
Decreased risk of exceeding national norms for weight at birth
Full Information
NCT ID
NCT02346162
First Posted
January 20, 2015
Last Updated
April 4, 2022
Sponsor
Kaiser Permanente
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02346162
Brief Title
PREPARE: A Randomized Trial of a Pre-pregnancy Weight Loss Intervention
Official Title
PREPARE: A Randomized Trial of a Pre-pregnancy Weight Loss Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 21, 2019 (Actual)
Study Completion Date
June 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The US obesity epidemic is being transmitted to the next generation. Growing evidence suggests that both a mothers' weight at pregnancy onset, and excessive weight gain during pregnancy, are associated with increased risk of pregnancy-related complications such as gestational diabetes and pre-eclampsia, and an increased risk that her child will become obese and face obesity-related health issues in later life.
Currently, over one-third of reproductive-aged women in the U.S. are obese [body mass index (BMI) ≥ 30]. Our research team has shown that we can improve birth weight outcomes in babies of obese women who start a weight-management intervention program at 14 to 15 weeks of their pregnancy (soon after their first prenatal visit). However, organogenesis and metabolic programming begin early in the first trimester, well before the first prenatal visit. Therefore, waiting to address mothers' weight, physical activity, and diet quality until the first prenatal visit is not optimal. Given the need to reach overweight and obese women prior to pregnancy, and the Institute of Medicine's (IOM's) recent recommendation, based on observational studies, that women should reach a healthy weight before conceiving, this randomized clinical trial will evaluate a comprehensive preconception weight loss program.
Detailed Description
The goals are to help overweight and obese women (BMI ≥ 27) who are considering pregnancy to adopt improved dietary and physical activity habits and lose weight prior to becoming pregnant, and then help them maintain those habits and prevent excessive weight gain during their pregnancy. We model this intervention after successful, frequent-contact interventions designed by ourselves and other investigators. We start with face-to-face counseling followed by frequent telephone counseling contacts. The expected outcomes for mothers include reduced pregnancy-related weight gain (primary) and lower weight at the start of pregnancy (secondary) and for babies, decreased risk of exceeding national norms for weight at birth (secondary).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese
Keywords
Pre-pregnancy, Weight management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Weight management intervention
Arm Title
Usual Care Control
Arm Type
Other
Arm Description
Usual Care for planning healthy pregnancy
Intervention Type
Behavioral
Intervention Name(s)
Weight management
Intervention Description
Phone counseling for pre-pregnancy weight loss and weight maintenance when BMI </=25, and when pregnant, weight gain within IOM guidelines.
Intervention Type
Other
Intervention Name(s)
Usual Care Control
Intervention Description
Usual care control participants receive general dietary advice as it relates to planning for a healthy pregnancy (e.g. folate requirements, prenatal vitamins, smoking cessation, alcohol cessation, and prenatal food safety).
Primary Outcome Measure Information:
Title
Reduced pregnancy-related weight gain
Time Frame
1 day at the end of pregnancy
Secondary Outcome Measure Information:
Title
Lower weight at the start of pregnancy
Time Frame
Self-reported pre-pregnancy weight supplemented by weight at first prenatal visit (1 day)
Title
Decreased risk of exceeding national norms for weight at birth
Time Frame
birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Current Kaiser Permanente Northwest (KPNW) member
Expects to be KPNW member for at least 2 more years
Body Mass Index (BMI) ≥ 27
Not currently pregnant
Access to computer with Internet
Completion of screening diet assessment
English speaking
Exclusion Criteria:
Taking medication (insulin or pills) for treatment of diabetes
Gastrointestinal disease requiring special diet or medications (for example, ulcerative colitis, celiac sprue, phenylketonuria)
Currently receiving treatment for cancer
Renal disease (kidney disease requiring special diet or medication)
History of bariatric surgery
Use of prescription weight loss medications in the last three months
Another household member already participating in the Prepare study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin S LeBlanc, MD
Organizational Affiliation
Center for Health Research, Kaiser Permanente Northwest
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victor J Stevens, PhD
Organizational Affiliation
Center for Health Research, Kaiser Permanente Northwest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anna Edelmann
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Any information from this study we present in reports or publications will not identify any individual.
Citations:
PubMed Identifier
32687819
Citation
LeBlanc ES, Smith NX, Vesco KK, Paul IM, Stevens VJ. Weight loss prior to pregnancy and subsequent gestational weight gain: Prepare, a randomized clinical trial. Am J Obstet Gynecol. 2021 Jan;224(1):99.e1-99.e14. doi: 10.1016/j.ajog.2020.07.027. Epub 2020 Jul 18.
Results Reference
result
PubMed Identifier
36238226
Citation
LeBlanc ES, Boisvert C, Catlin C, Lee MH, Smith N, Vesco KK, Savage J, Mitchell DC, Gruss I, Stevens VJ. Prepare randomized clinical trial: Acceptability, engagement, and lifestyle effects of a weight loss intervention beginning in pre-pregnancy. Obes Sci Pract. 2022 Feb 24;8(5):603-616. doi: 10.1002/osp4.596. eCollection 2022 Oct.
Results Reference
derived
PubMed Identifier
34313765
Citation
LeBlanc ES, Smith NX, Vesco KK, Hillier TA, Stevens VJ. Weight Loss Prior to Pregnancy and Early Gestational Glycemia: Prepare, a Randomized Clinical Trial. J Clin Endocrinol Metab. 2021 Nov 19;106(12):e5001-e5010. doi: 10.1210/clinem/dgab547.
Results Reference
derived
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PREPARE: A Randomized Trial of a Pre-pregnancy Weight Loss Intervention
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