- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01771133
Pregnancy and EARly Lifestyle Improvement Study (PEARLS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obesity and hyperglycemia in pregnancy are thought to impact fetal growth through over-nutrition and may stress the fetal pancreas because of the increased demand for insulin. Such intrauterine programming events affect birth weight and raise the offspring's risk trajectory for future obesity, type 2 diabetes, cardiovascular disease and premature death. Investigators propose to conduct a randomized controlled trial in 200 overweight or obese pregnant Puerto Rican women (free of diabetes) and their infants, to favorably impact metabolic health in mothers and infants.
Women presenting will be randomized to a lifestyle modification intervention or standard care control group before 16 gestational weeks. The intervention will focus on improving: (1) physical activity levels and (2) diet quality and calorie intake. The lifestyle intervention will be delivered within an empowerment theoretical framework through individualized intervention sessions, intensive group sessions, and by phone calls. The intervention will continue through the first postpartum year and will include the infants. A key objective is to evaluate whether the intervention optimizes infant BMI z-score. We will also evaluate whether the intervention increases the number of women who experience appropriate gestational weight gain, and evaluate several additional aims including relating the interventions with improved insulin sensitivity and beta-cell function in the women, and insulin concentrations adjusted for glucose in their infants.This study will also help us to identify and overcome barriers to develop effective ways of intervening during pregnancy to meaningfully improve cardio-metabolic risk trajectories of future generations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
San Juan, Puerto Rico, 00935
- University of Puerto Rico Medical Science Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Singleton viable pregnancy. A twin pregnancy reduced to singleton before 14 weeks by project gestational age is acceptable. An ultrasound must be conducted before randomization that shows a fetal heartbeat; there should be no evidence of more than one fetus on the most recent pre-randomization ultrasound.*
- Gestational age at randomization no earlier than 9 weeks 0 days and no later than 15 weeks 6 days based on an algorithm that compares the last menstrual period (LMP) date and data from the earliest ultrasound.*
- BMI ≥25 kg/m2 based on first trimester measured weight and on measured height. The earliest weight measurement before randomization, measured specifically for the study will be used. Reported pre-pregnancy weight will not be used to determine eligibility because of the potential for inaccuracy. If the earliest weight measurement is conducted at 140 to 146 weeks or 150 to 156 weeks, 1 lb or 2 lbs will be subtracted from the measured weight respectively, to adjust to a first trimester weight.*
- Age ≥ 18*
Exclusion Criteria:
- Diagnosis of diabetes prior to pregnancy (reported physician diagnosed diabetes other than GDM in previous pregnancy or taking insulin or medications to treat diabetes), or an HbA1c ≥ 6.5 % or other test result (elevated fasting glucose ≥126 mg/dL/7.0 mmol/L or 2 h glucose ≥200 mg/dL/11.1 mmol/L when OGTT is completed) suggestive of pre-pregnancy diabetes. All potential participants will have HbA1c performed prior to randomization.*
- Known fetal anomaly *
- Planned termination of pregnancy*
- History of three or more consecutive first trimester miscarriages*
- Past history of anorexia or bulimia by medical history or patient report. Binge eating disorder is not an exclusion*
- Current eating disorder diagnosed by EDE-Q questions 2-4 and confirmed after discussion with the participant by study staff*
- Actively suicidal defined as a value ≥ 2 on the BDI-II question 9*
- Prior or planned (within 1 year of expected delivery) bariatric surgery*
Current use of one or more of the following medications: *
- Metformin
- Systemic steroids
- Antipsychotic agents
- Anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight
- Medications for ADHD including amphetamines and methylphenidate
- Continued use of weight loss medication including OTC and dietary supplements for weight loss *
Contraindications to aerobic exercise in pregnancy specified in the ACOG Committee Opinion #267, 2002 (reaffirmed 2009) *
- Hemodynamically significant heart disease defined as an AHA class II (short of breath with exercise) or greater
- Restrictive lung disease (e.g. pulmonary fibrosis)
- Poorly controlled seizure disorder
- Poorly controlled hypertension (blood pressure ≥160/110)
- History of extreme sedentary lifestyle (e.g. bed bound)
- Orthopedic limitations to aerobic exercise
- Severe anemia defined as a hemoglobin < 8 g/dl or hematocrit <24 %
- Participation in another interventional study that influences weight control*
- Enrollment in this trial in a previous pregnancy*
- Intention of the participant or of the care provider for the delivery to be outside the LIFE-Moms Consortium hospital*
- Participant's unwillingness or inability to commit to a 1 year follow-up of herself or her child, including planning to move away*
- Past or current intravenous drug use (visual check for injection marks, recorded methadone use, self-report)
- Self-reported HIV infection (confirmed from medical records or baseline test results)
- Inability to functionally participate in group sessions and other study requirements on a regular basis during the complete duration of the study, including but not limited to the documented use of the accelerometer for the periods required by the study
- Non Spanish speaking
- Plan on giving up infant for adoption
'*' Core eligibility criterion for the LIFE-Moms Consortium
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Lifestyle and nutrition control group
The control arm will receive routine prenatal care in the prenatal clinic.
They will receive regular phone calls and mailings, token gifts and some useful information from data collected in the study, such as physical activity, feedback on behavior throughout the study.
To additionally promote adherence (since they will have less contact with study staff), we will include 2 pre-partum and 1 post-partum group sessions meant to increase bonding between participants and retention of control participants.
These sessions will include general pregnancy information not related to our interventions.
|
|
Active Comparator: Lifestyle intervention group
The lifestyle intervention will be delivered within an empowerment framework which promotes behavioral changes by facilitating health self-efficacy, utilizing self-praise and using active coping skills to address and manage emotions.
A nutrition component primarily focuses on total calories, for which energy requirements will be individually calculated for each pregnant women and on general diet quality with an emphasis on carbohydrate quality.
It will also promote an overall healthy diet, emphasizing improvement of fat quality and reducing salt intake.
A physical activity component focuses on promoting regular movement and minimizes the duration of bouts of sitting or lying during waking hours as well as non-exercise activity.
|
The lifestyle intervention will be delivered within an empowerment framework which promotes behavioral changes by facilitating health self-efficacy, utilizing self-praise and using active coping skills to address and manage emotions.
A nutrition component primarily focuses on total calories, for which energy requirements will be individually calculated for each pregnant women and on general diet quality with an emphasis on carbohydrate quality.
It will also promote an overall healthy diet, emphasizing improvement of fat quality and reducing salt intake.
A physical activity component focuses on promoting regular movement and minimizes the duration of bouts of sitting or lying during waking hours as well as non-exercise activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gestational Weight Gain
Time Frame: Delivery
|
To determine if a combined lifestyle intervention of nutrition and physical activity delivered within an empowerment theoretical framework in pregnant women result in a greater percent of women who gain the appropriate amount of gestational weight gain, as defined by the Institute of Medicine, compared to those receiving standard care.
|
Delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Does the lifestyle intervention (compared with control) affect the infant BMI z-score at 12 months of age (major
Time Frame: 12 months post-partum
|
To evaluate whether the intervention influences infant BMI by comparison of infants of mothers randomized to either active intervention or control intervention
|
12 months post-partum
|
Estimates of beta-cell function and insulin action in the mother.
Time Frame: 35,0-36,6 wks 48,0-56,0 wks pp
|
Estimation of beta-cell function, insulin resistance, and insulin sensitivity using data obtained from a frequently sampled 75g OGTT.
Calculations will be based on established equations that have been validated for use in pregnancy, such as the model-based approach and the oral disposition index.
|
35,0-36,6 wks 48,0-56,0 wks pp
|
Maternal blood pressure during pregnancy
Time Frame: 24,0-27,6 wks; 35,0-36,6 wks; Delivery
|
24,0-27,6 wks; 35,0-36,6 wks; Delivery
|
|
Maternal blood pressure postpartum.
Time Frame: 4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp
|
4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp
|
|
Infant blood pressure
Time Frame: < 48 hour pp; 4-6 wks pp; 16-24 wks pp
|
< 48 hour pp; 4-6 wks pp; 16-24 wks pp
|
|
Post-partum weight retention
Time Frame: 4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp
|
4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp
|
|
Body circumferences in mothers
Time Frame: 24,0-27,6 wks 35,0-36,6 wks 4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp
|
24,0-27,6 wks 35,0-36,6 wks 4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp
|
|
Body circumferences in infants
Time Frame: < 48 hour pp 4-6 wks pp 16-24 wks pp 48-56 wks pp
|
< 48 hour pp 4-6 wks pp 16-24 wks pp 48-56 wks pp
|
|
Skinfold measures in infants
Time Frame: < 48 hour pp 16-24 wks pp 48-56 wks pp
|
< 48 hour pp 16-24 wks pp 48-56 wks pp
|
|
Sleep quality and duration in the prenatal periods in mothers
Time Frame: 35,0-36,6 wks
|
Sleep quality and duration will be assessed using an accelerometer in order to assess duration and quality of sleep
|
35,0-36,6 wks
|
Sleep quality and duration in the postpartum periods in mothers and infants
Time Frame: 48,0-56,0 wks pp
|
Sleep quality and duration will be assessed using an accelerometer in order to assess duration and quality of sleep
|
48,0-56,0 wks pp
|
Insulin levels adjusted for glucose levels in the infants
Time Frame: < 48 hour pp 16-24 wks pp 48-56 wks pp
|
< 48 hour pp 16-24 wks pp 48-56 wks pp
|
|
Developmental measures in infants
Time Frame: < 48 hour pp 16-24 wks pp 48-56 wks pp
|
< 48 hour pp 16-24 wks pp 48-56 wks pp
|
|
Anthropometric and growth measures in the infants
Time Frame: < 48 hour pp 4-6 wks pp 16-24 wks pp 48-56 wks pp
|
< 48 hour pp 4-6 wks pp 16-24 wks pp 48-56 wks pp
|
|
Psychosocial measures in the mothers
Time Frame: 35,0-36,6 wks 48,0-56,0 wks pp
|
35,0-36,6 wks 48,0-56,0 wks pp
|
|
Pregnancy and Delivery complications
Time Frame: 35,0-36,6 wks delivery
|
35,0-36,6 wks delivery
|
|
Fetal and neonatal adverse outcomes
Time Frame: Birth and < 48 hour pp
|
Birth and < 48 hour pp
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Additional Outcome Measures
Time Frame: 12 months
|
Is there an interaction between gestational glucose abnormalities and physical activity/nutrition on infant outcomes?
|
12 months
|
Additional Outcome Measures
Time Frame: Pre-partum and post-partum
|
What is the contribution of the different intervention components and varying levels of compliance on the maternal and infant outcomes as it is important to assess the feasibility of the intervention and the positive lifestyle changes in women and their infants assigned to the intervention compared to the control group?
|
Pre-partum and post-partum
|
Additional Outcome Measures
Time Frame: Pre-partum and post-partum
|
Does the sleep quality and duration have an impact on glucose tolerance or GWG?
|
Pre-partum and post-partum
|
Additional Outcome Measure
Time Frame: Pregnancy
|
GIS (Geographic Information Systems) will be used to evaluate the association between participants' environments in terms of proximity to parks and recreation facilities, restaurants, mass transit, etc and the major study outcomes, as well as compliance with physical activity and nutrition interventions.
|
Pregnancy
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kaumudi J Joshipura, ScD MS, University of Puerto Rico Medical Science Campus
- Principal Investigator: Paul W Franks, PhD MPhil MS, Lund University
Publications and helpful links
General Publications
- Redman LM, Drews KL, Klein S, Horn LV, Wing RR, Pi-Sunyer X, Evans M, Joshipura K, Arteaga SS, Cahill AG, Clifton RG, Couch KA, Franks PW, Gallagher D, Haire-Joshu D, Martin CK, Peaceman AM, Phelan S, Thom EA, Yanovski SZ, Knowler WC; LIFE-Moms Research Group. Attenuated early pregnancy weight gain by prenatal lifestyle interventions does not prevent gestational diabetes in the LIFE-Moms consortium. Diabetes Res Clin Pract. 2021 Jan;171:108549. doi: 10.1016/j.diabres.2020.108549. Epub 2020 Nov 22.
- Peaceman AM, Clifton RG, Phelan S, Gallagher D, Evans M, Redman LM, Knowler WC, Joshipura K, Haire-Joshu D, Yanovski SZ, Couch KA, Drews KL, Franks PW, Klein S, Martin CK, Pi-Sunyer X, Thom EA, Van Horn L, Wing RR, Cahill AG; LIFE-Moms Research Group. Lifestyle Interventions Limit Gestational Weight Gain in Women with Overweight or Obesity: LIFE-Moms Prospective Meta-Analysis. Obesity (Silver Spring). 2018 Sep;26(9):1396-1404. doi: 10.1002/oby.22250. Epub 2018 Sep 6.
- Clifton RG, Evans M, Cahill AG, Franks PW, Gallagher D, Phelan S, Pomeroy J, Redman LM, Van Horn L; LIFE-Moms Research Group. Design of lifestyle intervention trials to prevent excessive gestational weight gain in women with overweight or obesity. Obesity (Silver Spring). 2016 Feb;24(2):305-13. doi: 10.1002/oby.21330. Epub 2015 Dec 26.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1U01HD072834 (U.S. NIH Grant/Contract)
- U01HD072834 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hyperglycemia
-
Mayo ClinicCompletedHospital Hyperglycemia | Post-transplant HyperglycemiaUnited States
-
Zealand University HospitalNot yet recruitingStress Hyperglycemia | Postoperative Hyperglycemia
-
University of CopenhagenUnknownSurgery--Complications | Hyperglycemia Stress | Hyperglycemia Steroid-inducedDenmark
-
University of LeedsCompletedEffect of Food on Postprandial HyperglycemiaUnited Kingdom
-
Emory UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...RecruitingHyperglycemia StressUnited States
-
Loughborough UniversityUniversity of BedfordshireCompletedPostprandial HyperglycemiaUnited Kingdom
-
Centre Hospitalier Universitaire de BesanconEli Lilly and Company; AstraZenecaCompleted
-
Medical University of ViennaCompleted
-
Addis Ababa UniversityCompletedHyperglycemia, Postprandial
-
University of Eastern FinlandFinnsugar LtdCompletedHyperglycemia, PostprandialFinland
Clinical Trials on Lifestyle intervention group
-
Ullevaal University HospitalThe Royal Norwegian Ministry of Health; The Norwegian Women´s Public Health...Unknown
-
Chinese University of Hong KongCompletedObstructive Sleep ApneaChina
-
Oslo Metropolitan UniversityRecruiting
-
Jordi Gol i Gurina FoundationInstituto de Salud Carlos III; Department of Health, Generalitat de CatalunyaUnknownType 2 Diabetes MellitusSpain
-
Northwestern UniversityNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...CompletedPregnancy | Weight GainUnited States
-
Baylor College of MedicineUnited States Department of DefenseCompleted
-
Brazilian National Cancer InstituteSuspendedObesity | Life Style | Endometrium CancerBrazil
-
Université de SherbrookeFonds de la Recherche en Santé du Québec; Diabetes QuébecCompletedGestational Diabetes | Excessive Weight Gain During PregnancyCanada
-
Universidad de SonoraCompletedChildhood ObesityMexico
-
Fundacion para la Investigacion y Formacion en...Instituto de Salud Carlos IIICompleted