Clinical trial NCT01771133: Pregnancy and EARly Lifestyle Improvement Study
Official title: Pregnancy and EARly Lifestyle Improvement Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Hyperglycemia
Keywords: Obesity
Maternal Welfare
Child Welfare
Nutritional Sciences
Clinical Trial
Pregnancy
Physical activity
Fetal Development
Metabolic Diseases
Life style
Behavior and Behavior Mechanisms
LIFE-Moms
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-01-18
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators propose to conduct a randomized controlled trial in 200 overweight/obese pregnant women and their offspring. The prenatal intervention will emphasize improving diet and physical activity. The lifestyle intervention will be delivered within an empowerment theoretical framework through a combination of group sessions, individual counseling, and by monitoring compliance to diet and physical activity to further tailor the intervention. The post-partum intervention sessions will include mothers and their offspring and will focus on breastfeeding, improving physical activity and quality of the diet and feeding practices through the first post-partum year. As part of routine prenatal care, participants in both the control and intervention arms will be given health-related advice. Since the majority of participants are expected to be eligible for the Women, Infants and Children (WIC) program, both groups will also receive assistance through WIC as per their routine policies. Our primary outcome is Gestational Weight Gain (GWG). The major secondary outcome of interest is infant BMI z-score at 12 months of age, and the investigators will also be evaluating several metabolic outcomes in mothers and infants.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gestational Weight Gain
timeFrame: Delivery
Secondary outcomes:
measure: Does the lifestyle intervention (compared with control) affect the infant BMI z-score at 12 months of age (major
timeFrame: 12 months post-partum
measure: Estimates of beta-cell function and insulin action in the mother.
timeFrame: 35,0-36,6 wks 48,0-56,0 wks pp
measure: Maternal blood pressure during pregnancy
timeFrame: 24,0-27,6 wks; 35,0-36,6 wks; Delivery
measure: Maternal blood pressure postpartum.
timeFrame: 4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp
measure: Infant blood pressure
timeFrame: < 48 hour pp; 4-6 wks pp; 16-24 wks pp
measure: Post-partum weight retention
timeFrame: 4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp
measure: Body circumferences in mothers
timeFrame: 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
measure: Body circumferences in infants
timeFrame: < 48 hour pp 4-6 wks pp 16-24 wks pp 48-56 wks pp
measure: Skinfold measures in infants
timeFrame: < 48 hour pp 16-24 wks pp 48-56 wks pp
measure: Sleep quality and duration in the prenatal periods in mothers
timeFrame: 35,0-36,6 wks
measure: Sleep quality and duration in the postpartum periods in mothers and infants
timeFrame: 48,0-56,0 wks pp
measure: Insulin levels adjusted for glucose levels in the infants
timeFrame: < 48 hour pp 16-24 wks pp 48-56 wks pp
measure: Developmental measures in infants
timeFrame: < 48 hour pp 16-24 wks pp 48-56 wks pp
measure: Anthropometric and growth measures in the infants
timeFrame: < 48 hour pp 4-6 wks pp 16-24 wks pp 48-56 wks pp
measure: Psychosocial measures in the mothers
timeFrame: 35,0-36,6 wks 48,0-56,0 wks pp
measure: Pregnancy and Delivery complications
timeFrame: 35,0-36,6 wks delivery
measure: Fetal and neonatal adverse outcomes
timeFrame: Birth and < 48 hour pp
Other outcomes:
measure: Additional Outcome Measures
timeFrame: 12 months
measure: Additional Outcome Measures
timeFrame: Pre-partum and post-partum
measure: Additional Outcome Measures
timeFrame: Pre-partum and post-partum
measure: Additional Outcome Measure
timeFrame: Pregnancy
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico Medical Science Campus
Study officials:
affiliation: University of Puerto Rico Medical Science Campus
name: Kaumudi J Joshipura, ScD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University
name: Paul W Franks, PhD MPhil MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.