Pregnancy and EARly Lifestyle Improvement Study

NCT01771133 | Terminated DMC

• 2 other identifiers: 1U01HD072834U01HD072834
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Gestational Weight Gain

  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 Outcomes (17)

• Does the lifestyle intervention (compared with control) affect the infant BMI z-score at 12 months of age (major

  12 months post-partum

• Estimates of beta-cell function and insulin action in the mother.

  35,0-36,6 wks 48,0-56,0 wks pp

• Maternal blood pressure during pregnancy

  24,0-27,6 wks; 35,0-36,6 wks; Delivery

• Maternal blood pressure postpartum.

  4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp

• Infant blood pressure

  < 48 hour pp; 4-6 wks pp; 16-24 wks pp

Other Outcomes (4)

• Additional Outcome Measures

  12 months

• Additional Outcome Measures

  Pre-partum and post-partum

• Additional Outcome Measures

  Pre-partum and post-partum

Study Arms (2)

Lifestyle and nutrition control group

NO INTERVENTION

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.

Lifestyle intervention group

ACTIVE COMPARATOR

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.

Behavioral: Lifestyle intervention group

Interventions

Lifestyle intervention group BEHAVIORAL

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.

Lifestyle intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\*

You may not qualify if:

• 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\*
• 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) \*

Sponsors & Collaborators

• University of Puerto Rico: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Puerto Rico Medical Science Campus

San Juan, 00935, Puerto Rico

Location

Related Publications (5)

• Cabre HE, Drews KL, Pomeroy J, Keadle SK, Arteaga SS, Franks PW, Haire-Joshu D, Knowler WC, Pi-Sunyer X, Van Horn L, Wing RR, Cahill AG, Clifton RG, Couch KA, Gallager D, Josefson JL, Joshipura K, Klein S, Martin CK, Peaceman AM, Phelan S, Thom EA, Redman LM; LIFE-Moms Research Group. LIFE-Moms: effects of multicomponent lifestyle randomized control trial on physical activity during pregnancy in women with overweight and obesity. Int J Behav Nutr Phys Act. 2025 Sep 30;22(1):119. doi: 10.1186/s12966-025-01805-9.

  PMID: 41029405 DERIVED

• Flanagan EW, Drews KL, Cade WT, Franks PW, Gallagher D, Phelan S, Van Horn L, Redman LM. Metabolic Health and Heterogenous Outcomes of Prenatal Interventions: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2528264. doi: 10.1001/jamanetworkopen.2025.28264.

  PMID: 40839263 DERIVED

• 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.

  PMID: 33238176 DERIVED

• 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.

  PMID: 30230252 DERIVED

• 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.

  PMID: 26708836 DERIVED

MeSH Terms

Conditions

Obesity; Hyperglycemia; Motor Activity; Metabolic Diseases; Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders

Study Officials

• Kaumudi J Joshipura, ScD MS

  University of Puerto Rico Medical Science Campus

  PRINCIPAL INVESTIGATOR

• Paul W Franks, PhD MPhil MS

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Center for Clinical Research and Health Promotion

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 18, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

PR (1)