ObesityPEARLSNCT01771133
Pregnancy and EARly Lifestyle Improvement Study
A study testing Lifestyle intervention group in people with Obesity and Hyperglycemia, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hyperglycemia
- What is being tested?
- Lifestyle intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Jan 2013to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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*
Who cannot join
- 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*
Show all 33Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
University of Puerto Rico Medical Science Campus
San Juan, 00935
About this study
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.
Read the 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.
- Conditions
- Obesity, Hyperglycemia
- Being tested
- Lifestyle intervention group
- 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
- Medical subject headings
- Obesity, Hyperglycemia, Motor Activity, Metabolic Diseases, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle intervention groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Lifestyle intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Delivery
Secondary outcomes (17)
Does the lifestyle intervention (compared with control) affect the infant BMI z-score at 12 months of age (major
To evaluate whether the intervention influences infant BMI by comparison of infants of mothers randomized to either active intervention or control intervention
Measured: 12 months post-partum
Estimates of beta-cell function and insulin action in the mother.
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.
Measured: 35,0-36,6 wks 48,0-56,0 wks pp
Maternal blood pressure during pregnancy
Measured: 24,0-27,6 wks; 35,0-36,6 wks; Delivery
Maternal blood pressure postpartum.
Measured: 4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp
Infant blood pressure
Measured: < 48 hour pp; 4-6 wks pp; 16-24 wks pp
Post-partum weight retention
Measured: 4,0-6,0 wks pp; 16,0-24,0 wks pp; 48,0-56,0 wks pp
Body circumferences in mothers
Measured: 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
Measured: < 48 hour pp 4-6 wks pp 16-24 wks pp 48-56 wks pp
Skinfold measures in infants
Measured: < 48 hour pp 16-24 wks pp 48-56 wks pp
Sleep quality and duration in the prenatal periods in mothers
Sleep quality and duration will be assessed using an accelerometer in order to assess duration and quality of sleep
Measured: 35,0-36,6 wks
Sleep quality and duration in the postpartum periods in mothers and infants
Sleep quality and duration will be assessed using an accelerometer in order to assess duration and quality of sleep
Measured: 48,0-56,0 wks pp
Insulin levels adjusted for glucose levels in the infants
Measured: < 48 hour pp 16-24 wks pp 48-56 wks pp
Developmental measures in infants
Measured: < 48 hour pp 16-24 wks pp 48-56 wks pp
Anthropometric and growth measures in the infants
Measured: < 48 hour pp 4-6 wks pp 16-24 wks pp 48-56 wks pp
Psychosocial measures in the mothers
Measured: 35,0-36,6 wks 48,0-56,0 wks pp
Pregnancy and Delivery complications
Measured: 35,0-36,6 wks delivery
Fetal and neonatal adverse outcomes
Measured: Birth and < 48 hour pp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: recruiting or enrolling participants has halted prematurely by Life-Moms Consortium and will not resume; participants are no longer being examined or treated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Kaumudi Joshipura, University of Puerto Rico
- Investigators
- Kaumudi J Joshipura, ScD MS, Principal investigator, University of Puerto Rico Medical Science CampusPaul W Franks, PhD MPhil MS, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771133
- Sponsor's protocol ID
- 1U01HD072834
- Other IDs
- U01HD072834
- Acronym
- PEARLS
- Status last verified
- Oct 2016
- First submitted
- 15 Jan 2013
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 41029405Flanagan 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.
PubMed 40839263Redman 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.
PubMed 33238176Peaceman 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.
PubMed 30230252Clifton 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.
PubMed 26708836
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy and EARly Lifestyle Improvement Study
- ClinicalTrials.gov ID
- NCT01771133
- Acronym / sponsor ID
- PEARLS / 1U01HD072834
- Conditions
- Obesity, Hyperglycemia
- Keywords
- Obesity, Maternal Welfare, Child Welfare, Nutritional Sciences, Clinical Trial, Pregnancy, Physical activity, Fetal Development
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruiting or enrolling participants has halted prematurely by Life-Moms Consortium and will not resume; participants are no longer being examined or treated.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Lifestyle intervention groupThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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*
Key exclusion criteria (33 listed)
- 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*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle intervention groupThe 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. | Behavioural | Lifestyle intervention group |
Primary outcome
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.
17 secondary outcomes
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
Estimates of beta-cell function and insulin action in the mother.
Time frame: 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
Maternal blood pressure postpartum.
Time frame: 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
Post-partum weight retention
Time frame: 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
Body circumferences in infants
Time frame: < 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
Sleep quality and duration in the prenatal periods in mothers
Time frame: 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
Insulin levels adjusted for glucose levels in the infants
Time frame: < 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
Anthropometric and growth measures in the infants
Time frame: < 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
Pregnancy and Delivery complications
Time frame: 35,0-36,6 wks delivery
Fetal and neonatal adverse outcomes
Time frame: Birth and < 48 hour pp
Results and safety
The study was stopped early (reason given: recruiting or enrolling participants has halted prematurely by Life-Moms Consortium and will not resume; participants are no longer being examined or treated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Derived from this study: PubMed 41029405Cabre 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.
- Derived from this study: PubMed 40839263Flanagan 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.
- Derived from this study: PubMed 33238176Redman 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.
- Derived from this study: PubMed 30230252Peaceman 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.
- Derived from this study: PubMed 26708836Clifton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaumudi J Joshipura, ScD MS principal investigator
University of Puerto Rico Medical Science Campus
Paul W Franks, PhD MPhil MS principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention group in people with Obesity and Hyperglycemia, run by University of Puerto Rico at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruiting or enrolling participants has halted prematurely by Life-Moms Consortium and will not resume; participants are no longer being examined or treated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational Weight Gain (time frame: Delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01771133, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.